Sunday, June 28, 2009

Wireless Changing Medicine

Newly developed non-invasive sensors, coupled with body area networks via smart phones or gateway receivers to transmit data over the internet, have the potential to transform medicine according to Eric Topol M.D. As the Director of the Scripps Translational Science Institute, and the Chief Medical Officer at West Wireless Health Institute, he presented his ideas on the future of wireless and medicine on June 25th at the National Center for Research Resources Telehealth meeting held at NIH.

Dr Topol demonstrated the use of “smart band-aids” that are disposable and inexpensive to produce. They can track 24/7 most physiological parameters, including ECG heart rhythm, respiratory rate, blood pressure, temperature, EEG and sleep cycles, calories taken in and expended, pollen counts, air quality forced expiratory volume, position activity, and more.

He continued to say “Remote mobile monitoring can be transformative in preventing hospital readmissions for congestive heart failure, chronic obstructive pulmonary disease, and several other key chronic medical conditions. Medications can be tagged with micro sensors that are digestible and can be activated wirelessly or a drug could be given in a precise dose via a polymeric delivery transmitted through the skin at the moment of wireless activation.”

He pointed out that some of the key possibilities for using remote monitoring are for patients with chronic diseases particularly if the patient has multiple problems, or to use in the instances when physicians are dealing with high risk pregnancies, or perhaps be used as a personal emergency response system for the elderly in their home.

He explained how the Wireless Health Institute (WWHI) a new non-profit research and education institute located in San Diego California is one of the first medical research organizations dedicated to research on the use of wireless technologies.

WWHI has just announced that they will be doing clinical trials on their remote heart monitoring system using “Band Aid” like patches to send readings real time via a Bluetooth connection to the patient’s smart phone. The trial is designed to clinically validate remote wireless monitoring technology to proactively manage heart failure patients.

“Congestive heart failure is one of the largest and most problematic diagnoses in medicine today but fortunately heart failure is prototypic for remote wireless monitoring”, said Topol. The Institute will be collaborating with Corventis, Inc., on their first clinical research program with Dr. Topol leading the effort along with Don Jones, Vice President of Health and Life Sciences at Qualcomm and WWHI’s Chief Wireless Officer.

The trial is going to study CHF to find ways to prevent hospital readmissions. Participation will be offered to the sites supported by the NIH’s Clinical and Translational Science Award National Consortium consisting of 38 prestigious academic medical centers in the U.S. It is anticipated that this trial will be one of many trials.

In addition to the NCRR meeting, Dr. Topol delivered a keynote address on June 24th at a technology and policy forum on mHealth solutions hosted by CTIA-The Wireless Association. The Forum was held on Capitol Hill so that Congressional members, Obama administration officials, and medical and policy experts were able to have information on all the mobile medical applications available and understand how tremendous cost savings can be achieve with wireless health solutions.

Universities Receive Funds

Stanford University School of Medicine projects that had been stalled by budget shortfalls at NIH are now moving forward with $6.9 million in federal stimulus funding. Up to now, eleven of the newly funded projects have been peer reviewed and approved. Another six projects involve seeking supplemental grants to existing projects.

The biggest grant $1.6 million from the National Library of Medicine was awarded to Amar Das, M.D. PhD. Assistant Professor of Medicine and of Psychiatry and Behavioral Sciences at Stanford. The funding will enable researchers to develop methods so that scientists in the biomedical community can better understand disease patterns by extracting time-related and other useful information from large databases.

For example, the researchers have been working with the NIH-supported National Database for Autism Research. The information available from the database will help researchers examine neurodevelopmental problems in children and how they might be related to biological markers and imaging findings.

Dr Das reports that the grant originally was submitted as a three year project, but that he compressed it into two years to fit the stimulus program guidelines. He is planning to hire two new people to work on his staff, a software engineer and postdoctoral scholar, at the Stanford Center for Biomedical Informatics Research.

The University of Colorado received 33 grants totaling $12.7 million in stimulus funding mostly from NIH. The money will be used to support research on determining the cause of birth defects and to find ways to have better outcomes for patients suffering from lung ailments caused by life support machines.

For example, Mark Moss, M.D. a pulmonary critical care doctor at the University of Colorado Hospital and Professor in the UC Denver School of Medicine with $ 3 million in funding, will lead a five year clinical study to look at a dysfunction of the nerves or muscles called polyneuromyopathy, which is often a consequence of being on mechanical life support for seven days or more.

The funding was made available through the National Institute of Nursing Research and will pay for the first two years of the study to start July 1. The researchers will work with 400 patients to find a less invasive way to diagnose the condition and try to find out if intensive physical therapy will improve patient outcomes. NIH funding will also pay for the final three years of the study as well.

Dr. Moss told the Governor’s office that ARRA enables him and his colleagues to obtain research funding much faster than would have been possible otherwise and to start the study sooner.”

HHS Awards $35 Million Contract

HHS Secretary Kathleen Sebelius is pursuing new ways to make influenza vaccine. Protein Sciences Corporation, Inc., located in Meriden Connecticut, under a new HHS $35 million dollar contract will conduct the research. The contract could be extended up to five years at a total cost of $147 million and will be administered by the Office of Biomedical Advanced Research and Development Authority.

“The technology has advanced in recent years to a point that we believe it could help meet a surge in demand for U.S. based vaccine for seasonal and pandemic flu,” Secretary Sebelius said. “We want to use the technology to help our nation respond to emerging infectious diseases.”

With this new technology, known as recombinant influenza vaccine, a gene would be extracted from a flu virus and placed into an insect virus called baculovirus, which does not affect people and can multiply quickly to high levels in insect cells. The cells are purified to become a basic part of a human vaccine.

Using this method, vaccine candidates, clinical investigational lots, and commercial-scale vaccine production may be available faster than by using traditional vaccine production methods. Because the basic cells can be frozen and stored indefinitely, manufacturing large quantities of a vaccine is also faster using recombinant technology.

If this new technology is demonstrated to be safe and effective and the FDA licenses the new technology, the contract requires the company to establish domestic manufacturing capability to provide a finished vaccine within 12 weeks of pandemic onset and to produce at least 50 million doses of pandemic flu vaccine within six months of pandemic onset.

DOD&VA Making Changes

According to (, the House Armed Services Committee transferred most of the Military Health System’s proposed fiscal 2010 information technology budget to the Defense Secretary’s office. This was done because none of the IT projects that the Military Health Service has proposed during the past two years have found their way into the president’s budget request. This information was included in a report accompanying the recently released Defense Authorization bill.

The House Committee said it shifted $1.1 billion or 85 percent of the agency’s total $1.3 billion IT budget to the secretary’s office because a higher level of leadership oversight is required to ensure that existing problems with the department’s health information management and information technology programs are addressed to ensure better coordination among other department information technology efforts.

At the VA, the agency is implementing a new IT department wide management approach. Effective immediately, all new IT programs and projects at VA must be implemented using the Project Management Accountability System (PMAS). PMAS is an incremental development approach to ensure that frequent deliveries will be made to customers and to halt programs that fail to meet delivery milestones. This new system will ensure early identification and then correct failing IT programs.

The program must establish milestones to deliver to customers in short increments of at most every six months. Under PMAS, a third missed customer delivery milestone will cause the program to be halted and re-planned. Before the program can restart, substantial changes must be instituted, including a re-evaluation of the program and approach, plus the replacement of the program manager, contractors, and a portion of the government staff.

Wednesday, June 24, 2009

Bills to Improve Care

The “National MS and Parkinson’s Disease Registries Act” to establish national registries to better understand and treat neurological diseases was introduced on June 16th by Senators Byron Dorgan, Debbie Stabenow, Mark Udall, and Johnny Isakson.

Currently, a national coordinated system to collect and analyze data on MS or Parkinson’s disease does not exist for the 1.4 million Americans that are affected by both of the diseases. The lack of core information and knowledge about MS and Parkinson’s disease inhibits progress in biomedical research, the development of new and better treatments, and the creation of programs to help people fighting these diseases to live an independent and productive life.

The Agency for Toxic Substances and Disease Registry established a series of small pilot studies beginning in FY 2006 to evaluate the various methodologies that would be needed to create an MS surveillance system at the national level and now there is a need for the system to be developed into a national surveillance system to include not only information on MS but also on Parkinson’s disease.

The legislation recommends grants be awarded through the Director of the Agency for Toxic Substances and Disease Registry to use for the collection, analysis, and reporting of data. The bill would authorize $5,000,000 for each year 2010 through 2014. The legislation also recommends building and coordinating existing data with other public health systems.

The other systems that could be included in the project are the two MS surveillance pilot studies, the Department of Veterans Affairs Parkinson’s Disease and MS databases, current Parkinson’s disease registries in Nebraska and California, the MS registries in New York State, plus any other existing or relevant databases that collect or maintain information on neurological diseases and disorders.

The legislation calls for the establishment of an Advisory Committee on Neurological Disease Registries to include representatives from national voluntary health associations that focus on MS and Parkinson’s disease, NIH, Department of Veterans Affairs, Department of Defense, FDA, CDC, patients with the diseases, family members of the patients, clinicians, research scientists, epidemiologists, geneticists, statisticians, bioethicists, attorneys, and other interested individuals, and experts in the field.

The goal for the Advisory committee would be to not only develop and maintain the surveillance system, but also to use and coordinate existing databases, discuss the type of information to be collected and how it will be collected, the availability of the data, and how the application of the registry methodologies can be used to benefit other neurological diseases and disorders.

On the House side, Representatives Artur Davis, Steve Israel, and Mary Jo Kilroy on June 15th introduced the “Medicare Quality Cancer Care Demonstration Project Act of 2009.” The act would establish a cancer care demonstration to establish quality metrics and align Medicare payment incentives in the areas of treatment planning and end-of-life care for Medicare beneficiaries.

Although two of the critical components of cancer care are treatment planning and end-of-life care, none of the 153 quality measures in the CMS 2009 Physician Quality Reporting Initiative address overall treatment planning or end-of-life care for cancer patients. The medical literature suggests that adherence to quality metrics and evidence-based guidelines helps to lower costs.

The demonstration project would establish quality metrics and align Medicare payment incentives with $300,000,000 to be available each year to use for payments for documented cancer treatments. The demonstration project would also explore the potential to report quality data through registries or other electronic means that also could be used for treatment planning and end-of-life care.

Addressing Costs & Emergency Care

Recently, Governor Edward G. Rendell signed healthcare legislation resulting from his “Prescription for Pennsylvania” healthcare reform plan. The plan helps address the costs for healthcare and the state is now saving the state’s healthcare system billions of dollars since the plan has been implemented statewide.

In May, the Governor signed the legislation that will help the state to continue to contain costs. One of the bills prohibits healthcare providers from seeking reimbursement for a serious, preventable medical error. Approximately 140 patients who experience an adverse medical event that might be both serious and preventable die each year in Pennsylvania hospitals. The total charges for the hospitals amounted to $21.8 million dollars. About 3,500 other patients a year survive an adverse event for which charges are an additional $316 million a year. By signing the bill, it is illegal for healthcare providers to charge when they have made a serious, preventable medical mistake.

Another piece of legislation reauthorizes the Pennsylvania Health Care Cost Containment Council (PHC4). The work of the PHC4 is to improve patient safety and healthcare quality outcomes, as well as healthcare cost containment for the state’s purchasers such as businesses and labor unions.

A study showed that PHC4’s public reporting process prevented 1,500 deaths in one year in just six disease and treatment categories. PHC4’s own findings show improvements in hospital care over the past 12 years of public reporting have saved an estimated 49,000 lives and saved $1.7 billion in hospital charges.

The Philadelphia Inquirer reports that the first results of the Governors, “Prescription for Pennsylvania” plan show that the program’s chronic care initiative regarding diabetics is encouraging. Thirty two medical practices in the southeastern part of the state signed up and 44 percent of the 15,000 diabetic patients in the program gained ideal control of their blood sugar. That’s up from 33 percent a year ago. The number of people receiving chronic care attention is expanding and the program now extends to all parts of the state and involves 400 primary care providers covering 750,000 patients.

The state is addressing how best to provide emergency care especially if there is an H1N1 outbreak or any other type of emergency situation. According to the state Health Secretary Everette James, portable hospitals play a key part in Pennsylvania’s preparedness plans. These portable systems are flexible and can be used in areas that don’t have hospitals, or they can be used to support existing hospitals, or used as alternate care sites. The state received funding through HHS to purchase eight 50 bed portable hospital systems that are packaged as tow-behind trailer systems. The hospitals are positioned in strategic locations across the state.

The systems can function in a variety of capacities including triage, acute care and inpatient treatment. They can also be adapted for use as first aid stations, field hospitals, mass immunization sites or used for negative pressure isolation units for suspected infectious disease outbreaks. The portable hospital tent systems can be inflated in five minutes by six trained people and can be operational within two hours of an emergency notification.

Portable hospital staffing will be complemented by various volunteer organizations, including Emergency Medical Services Strike Teams, the State Emergency Registry of Volunteers in Pennsylvania (SERVPA), Medical Reserve Corps, and State Medical Response Teams.

Partnership Launched

The Woodruff Health Science Center at Emory University and the Ohio State University Medical Center are forming the Alliance for Predictive and Personalized Health. This partnership will transform healthcare into a more patient-centered system that will integrate scientific breakthroughs in genomics and molecular biology with advances in communications and information technology.

Personalized healthcare is the cornerstone of the Ohio State University Medical Center’s vision. In 2005, Ohio State formed a Center for Personalized Health Care to join programs in biomedical informatics, genomics and biomarker science, imaging, clinical trials and investigation, employee health/managed care, and clinical applications. In 2006, personalized healthcare practices were incorporated into the university health plans through the introduction of “Your Plan for Health”.

Predictive Health is a major initiative within Emory University’s strategic plan. In 2005, Emory and Georgia Tech established the Emory/Georgia Tech Predictive Health Institute to combine research investigating new genetic and protein biomarkers. The Center for Health Discover and Well-Being does clinical testing and translational research on predictors of health, disease risks, and prognosis.

The partnership will focus on:

  • Genomics/biomarker science—bio-banking, shared databases and shared core resources focused on cancer genetics, autoimmune imaging, critical care medicine, wound care, and behavioral medicine
  • Clinical investigation/clinical trials—phenotyping and biomarkers, access to information, medical and legal liability issues, education and training to change the culture around personalized healthcare, systems biology, and mathematical bioscience
  • Biomedical informatics and information technology—data integration, hypothesis testing, biomedical informatics, healthcare information systems, high throughput computing, and genomics/proteomics
  • Technology transfer and research management—intellectual property management and technology research and development to focus on databases, biobanks, and biomarkers

States Making Progress

States are making significant progress toward achieving interoperable communications, but more work is needed before information can be freely exchanged among jurisdictions during an emergency according to a new issue brief. The National Governors Association Center for Best Practice on June 18th published the brief “Advancing Public Safety Interoperable Communications: Recent State Actions” to highlight the states’ progress in advancing interoperability and to review the obstacles they face to efficiently share information across all levels of government.

The states continue to face challenges in five key areas and the brief recommends several strategies:

  • States need statewide interoperability coordinators with leadership abilities to administer interoperability programs in their state. For example, Virginia established the Office of the Commonwealth Interoperability Coordinator and currently 24 states now have full time coordinators with an additional 24 states planning to create full or part time statewide interoperability communication coordinator positions
  • Foster the development of Standard Operating Procedures through collaboration across disciplines. Minnesota’s response to the bridge collapse in 2007 demonstrates an example of a well maintained interoperability system
  • Fund technology for the long term by planning and budgeting for ongoing updates to systems, procedures, and documentation. Aging infrastructure, technological advances, and turnover in personnel requires continued maintenance to protect public safety. For example, Indiana’s Project Hoosier SAFE-T is funded by a $1.25 surcharge on all Department of Motor Vehicle transactions
  • States need to not only provide for basic training and exercises on interoperable communication equipment, but they also need to use routine events as an opportunity to test interoperable communications with other jurisdictions
  • Encourage the use of interoperable communications on a routine basis. Without regular use, the equipment and potentially effective technology will be cumbersome and inhibit a coordinated response. For example, South Carolina’s Palmetto network supports 350 jurisdictions on an 800MHz network

For more information, go to or call David Henry at (202) 624-5366.

Sunday, June 21, 2009

Project HealthDesign Findings

Developing EHR systems coupled with growing patient demand to access their personal health information has helped spur the boom to develop personal health records (PHRs). “Project HealthDesign” is a Robert Wood Johnson Foundation funded project to extend applications and enhance the range of services now offered by existing PHRs.

A final report and work products are available from the initial phase of the project and to download go to The team’s work captured key data from the work conducted by the first nine grantee teams as well as the team’s efforts to develop a common platform and explore the ethical, legal, and social issues tied to next-generation PHRs. The project is also releasing open sharable source code and other technical code documentation produced by the grantee teams.

Key findings from the report include:

  • Traditional concepts of privacy and confidentiality are in many respects inadequate to capture the way health information can be shared and distributed
  • Patients themselves have a large and unprecedented role in helping to safeguard their own health information
  • Society’s response to demands for privacy, confidentiality protection, and best practices for information management must take into account the health aspirations and social and economic fears of patients

“Project Health Design” will continue to explore Observations of Daily Living (ODLs) through a second round of funding from the RWJF’s Pioneer Portfolio. Grantee teams selected for the next phase of the project will work closely with patients and providers to assess and test the potential of ODLs to help better manage chronic illnesses. Specifically, the teams will demonstrate how information from everyday life can be collected, interpreted, and integrated into the clinical care process.

Developing 21st Century Materials

Tim Bryant a senior researcher reports that NASA’s Langley’s Research Center has developed a new material that not only benefits the aerospace sector but may also be used to extend the quality of life. Langley Research Center’s material “Soluble Imide” or referred to as LaRC-SI is a material that is highly flexible, resistant to chemicals, and can withstand extreme hot and cold temperatures. The material is suitable to use in medicine and this includes using the material for implantable devices.

Cardiac Resynchronization Therapy or CRT is designed to coordinate the contraction of the heart’s two lower chambers and improve the heart’s efficiency to increase blood flow. LaRC-SI can be used to insulate leads to the human heart from CRT—a stopwatch-sized device implanted into the chest. Placing a lead in the heart is widely recognized by physicians as the most challenging aspect of implanting CRT devices.

Medtronic Inc., a Minneapolis-based medical technology company worked with the Innovative Partnerships Program office at Langley, and as a result, NASA licensed the patented LaRC-SI insulation technology to the company. The company saw the potential of the highly flexible resin for use in its Attain Ability left-heart lead cardiac CRT device. The insulation material is one of the thinnest left-heart leads available. Clinical studies in the U.S. and Canada showed that physicians are successful in placing the Attain Ability lead 96.4 percent of the time. In April 2009, the FDA approved a left heart lead available for use with the new Medtronic CRT.

In another project, the Air Force is exploring material research in their Air Force Research Laboratory. Researchers have invented a process called “Reactive Surface Treatment” to provide individual protection on garments from warfare agents. Multifunctional garments have been produced that are antibacterial, waterproof, and oil resistant. Use of this material is ideal for the military, first responders, and anywhere where germs and fire is a problem.

The Air Force Laboratory licensed the nanotechnology process to Alexium Ltd. Based in Cambridge, U.K with U.S. headquarters in Dayton Ohio. The company is planning to commercialize the technology internationally in their U.S. operations.

Alexium’s initial focus for the apparel is for the U.S. military to use the material for first responders so they can be protected with chemical and biological protection gear. Following this will be other diverse applications ranging from using the surface treatment on anti-infective wound dressings, nurses uniforms, and hospital bedding.

Newborns Clearinghouse Needed

HRSA posted the announcement “Clearinghouse of New Born Screening Information” on June 15th soliciting applications to establish and maintain a central clearinghouse geared to newborns. The clearinghouse will be complete with current information, on resources, services, and research data that is now possible to obtain from newborn screenings. This information will be made available to parents, family members, expectant parents, health professionals, industry representatives, and the public to increase awareness, knowledge, and understanding of newborn screening. The clearinghouse also needs to maintain current data on quality indicators of newborn screening performance.

The closing date for the application is July 15th. Approximately $750,000 will fund one cooperative agreement award to develop the Clearinghouse. Eligible applicants can include any public or private entity, Indian tribe or tribal organization, faith-based or community organization.

The requirements for the Clearinghouse are to:

  • Be available on the Internet and updated at least quarterly
  • Provide links to websites that supply research-based information on newborn screening tests currently available throughout the U.S
  • Provide information for each state concerning newborn conditions and screening services available from laboratories
  • Provide information about current research
  • Provide information about the availability of federal funding for newborn and child screening for heritable disorders
  • Maintain an interactive forum

The Clearinghouse needs to be developed in consultation with health educators and medical homes. The Clearinghouse needs to take into consideration health literacy and cultural competence, so that a fully integrated Clearinghouse system is designed and implemented to serve the needs of a diverse population.

For more information, go to

Help for Health Clinics

Nurse-Managed Health Clinics (NMHCs) need more funding to provide wellness services and to strengthen the healthcare safety net. The goal is to expand access to chronic disease management services for geriatric and medically underserved populations.

NMHCs reinforce the medical home concept by providing a critical first level of care for populations living in rural areas with limited access to physicians and other primary care providers. NMHC patients participating in wellness services are connected to a medical home through established referral networks.

Legislation called the “Nurse-Managed Health Clinic Investment Act of 2009 (H.R. 2754), was recently introduced by Representatives Lois Capps from California and Lee Terry from Nebraska to help NMHCs improve access to quality healthcare and reduce health disparities. Representative Capps is a nurse and Vice-Chair of the House Energy and Commerce Health Subcommittee.

The legislation would help fund NMHCs so it would be possible to do a better job of meeting the needs of vulnerable populations in underserved communities. Basically, NMHCs offer primary care and behavioral health and wellness services and are located in easily accessible facilities such as public housing developments, senior living arrangements, schools, and community centers

The funds would be used to manage the program and for buildings and equipment. Approximately $50,000,000 would be provided for FY 2010 and funding would be provided as needed for FY 2011 through 2014.

A companion bill (S 1104) to fund NMHCs was introduced by Senator Daniel K. Inouye in the Senate. In addition, the Senator announced that the Department of Commerce in their Economic Development Administration has provided a grant for $1.2 million to go to Chaminade University in Honolulu. The funding will be used to establish a nursing simulation center complete with a nursing training suite, laboratories, and a state-of-the-art human simulator.

EHR Includes Dental Records

The Military Health System (MHS) AHLTA-Dental has consolidated Tri-Service Dental Records into a single secure electronic resource. The system now provides worldwide access to integrated medical and dental records and provides diagnoses to procedures with real-time access to the information.

“AHLTA-Dental ushers in a new era for medical readiness. With such extensive capabilities, the system improves the sharing of patient information by allowing clinicians to have easy access to patient information anytime. It creates opportunities to reinforce health promotion and disease prevention activities”, said Charles Campbell, MHS Chief Information Officer.

Approximately 377 dental clinics will train and implement AHLTA-Dental by the end of 2010, starting in the mid-Atlantic region. The Defense Health Information Management System’s Deployment Operations team is working closely with the Service Representatives to ensure that all military treatment facilities are ready and prepared for a successful launch at each site.

Almost 11,500 personnel are slated to complete two interactive web-based lessons to prepare for on-site training that includes eight hours of classroom training followed by four to six hours of on-the-job-training.

Wednesday, June 17, 2009

Plan to Help with Brain Injuries

Last January, over 60 of the top medical professionals in the field came together in New York City and drafted the first ever National Pediatric Acquired Brain Injury (PABI) Plan. The goal for the Sarah Jane Brain Project (SJB) is for the PABI plan to create a model system for children suffering from all pediatric acquired brain injuries.

According to the SJB Project, pediatric acquired brain injury is the leading cause of death and disability for children under 15 years of age in the U.S., causes more than 5,000 deaths per year, more than 17,000 permanent disabilities, and more than 1,000,000 hospitalizations.

Complete medical and therapy research data on children suffering from brain injuries is available to doctors, researchers, parents, caregivers, therapists, students and the public on the web site

The SJB Project is now in the process of establishing Centers of Excellence for the PABI Plan. The Foundation will work with 52 lead centers with one from each state, plus Puerto Rico and the District of Columbia to establish a national information system.

The National PABI Plan is estimated to cost $125 million annually to implement across the country. The plan will provide for seven categories of care for brain injury treatment to include prevention, acute care, rehabilitation, adult transition, rural/telehealth, mild TBI, and a virtual center that includes a family registry, electronic medical records, and healthcare information technology.

The SJB project will be led by Patrick Donohue, whose five day old daughter was violently shaken by her baby nurse, resulting in severe brain injury. Donohue founded the project because he found no existing standard or convenient system for families to be able to find access to consistent long-term quality care.

Gillian Hotz, PhD, Co-Director Pediatric Brain and SCI Program, Department of Neurosurgery University of Miami Miller School of Medicine, said “Through the efforts of the SJB project, we will now have a national system for ensuring that the greatest numbers of those with brain injury will benefit from breakthroughs in clinical management, biomedical engineering, stem cell-based therapy, and rehabilitation.”

The Center for Health Sciences (CHS) at Oklahoma State University is one of the leads selected for the SJB Project in Oklahoma. OSU-CHS will be responsible for developing and implementing a statewide master plan in partnership with other state healthcare and educational institutions and organizations. In addition, OSU-CHS will be able to use its telemedicine expertise, as well as the mobile telemedicine clinic for rural outreach efforts. Research facilities include a hyperbaric chamber and a biomedical research department available for translational studies with clinicians.

Kayse Shrum, D.O., Chair of Pediatrics at OSU-CHS reports that the system caring for pediatric acquired brain injuries is fragmented and without a comprehensive system in place, physicians are faced with reinventing the wheel with each case.

In Alabama, the University of Alabama at Birmingham and Children’s Hospital of Alabama will be the lead for their state. UAB’s Division of Pediatric Rehabilitation Medicine will be the coordinator for the project.

According to Drew Davis, M.D., Assistant Professor of Pediatric Rehabilitation Medicine at UAB and Director of the UAB Children’s Center, “There is a tremendous need for funding and resources so we can better understand the natural history of brain injury and develop appropriate interventions to help the children affected by acquired brain injury each year. We also need an evidence-based standardized approach to care for all phases of pediatric brain injury treatment and recovery.”

NY Creates Grant Program

New York Governor Paterson announced that the new Innovation Economy Matching Grants program will provide a 10 percent match in state funds for each ARRA dollar that the federal government designates for technology and research in crucial areas. New York will allocate $100 million over several years for this program which is expected to leverage one billion dollars in federal research funding.

The state will use the grant program primarily to support ARRA applications to federal agencies in strategic technology areas that have been identified as very important and critical to the state economy. These technology areas include renewable energy, clean tech and smart grid, nanotechnology, stem cell, biomedical and life sciences, advanced manufacturing, broadband, information technology, and cyber security.

New York State institutions of higher education, not-for-profit research institutions, and businesses are eligible to apply. Applications need to include how the research will economically benefit the state, demonstrate a tie to New York industry, and describe the potential applications for the research.

The Governor’s Stimulus Cabinet which has been closely monitoring opportunities for competitive funds will determine the parameters of the grants program and administer the program.

In addition to the grant program, the Governor announced that a life science innovation cluster will be created to bring together venture capital companies, medical schools, academic health centers, and research institution partners to develop the healthcare products of the future. The state has already created the Empire State Stem Cell Fund which has invested $118 million to support vital stem cell research at institutions across the state.

For more information, go to or contact John Demarest of NYStar at 518-292-5700.

Nebraska Implementing HIE

The Nebraska Health Information Initiative (NeHII) is currently communicating with many providers to connect them to the NeHII platform. Currently, the NEHII pilot program is evaluating the technical and functional capabilities of the HIE system with a limited number of participants. Today, there are 50 physicians and staff members using the Virtual Health Record and an additional 46 physicians asking to participate.

NeHII uses a hybrid federated model allowing for information to be stored on multiple databases on the back end. This model allows for better data storage and improved performance. Over the next few years, the HIE will be rolled out across the state and will ultimately become part of the Nationwide health Information Network.

The eHealth Council was created by the Nebraska Information Technology Commission (NTIC) to discuss eHealth initiatives in the state. The Council held a meeting in May 2009 on the strategies needed to support the development and expansion of HIEs.

One of the strategies is to support efforts to obtain HIE funding. This effort will be helped by working with other stakeholders to publicize health IT success stories within the state and to inform all stakeholders of the benefits of health IT.

The Legal Work Group of the Nebraska HISPC has reviewed Nebraska’s health information disclosure laws to identify laws that are more stringent than HIPAA. The result was that they found that the Nebraska Rev. Stat. 71-8403 stipulates that authorizations for release of medical records are valid for a maximum period of 180 days. The group recommended deleting the 180 day limit. HIPAA requirements would then apply allowing patients to state an expiration date or expiration event.

The Council’s e-Prescribing Work Group also identified a potential barrier to e-prescribing in a Nebraska statute that requires pharmacists to keep paper copies of prescriptions. A change to this statute would enable pharmacists to keep copies of prescriptions in a readily retrievable format.

The goal for the e-prescribing work group is to identify the barriers to e-prescribing and study the start-up and sustainability costs and resources to support the essential needs of pharmacies. Costs include transaction, software, and other optional fees.

Other problems hindering e-prescribing include changes in workflow which can temporarily reduce productivity for some, not being able to transmit prescriptions for controlled substances electronically, lack of training on the system, and prior negative experiences with the e-prescribing process.

The state also supports the development of interconnections among HIEs in the state and across borders. The idea is to determine the requirements for connections among exchanges and to explore options including connecting through NeHII or through NHIN’s open source Connect Software. There are plans to issue an RFP in the future.

The Council is going to work with the HIEs to map the adoption of standards to enable the integration of data from disparate sources into electronic medical records. The migration to HL7 version 3 has been identified as a potential strategy.

Other eHealth initiatives currently underway in Nebraska include:
  • The Nebraska Statewide Telehealth Network (NSTN) is going to connect nearly all of the state’s hospitals and public health departments particularly in rural Nebraska
  • The Western Nebraska HIE, has completed a plan and is beginning to implement a regional HIE
  • The Southeast Nebraska Behavioral Health Information Network is implementing the country’s first behavioral HIE
  • The Southeast Nebraska HIE now connects five rural health clinics, a home health agency, a nursing home, an assisted living facility, several EMS units, two pharmacies, and the St. Elizabeth Regional Health System in Lincoln

Defining "Meaningful Use"

ARRA authorizes CMS to provide reimbursement incentives to physician and hospital providers who are successful in becoming “meaningful users” of an electronic health record. These incentive payments will begin in 2011 and gradually phase down. Starting in 2015, providers are expected to have adopted and be actively using an EHR in compliance with the “meaningful use” definition or they will be subject to financial penalties under Medicare.

The Meaningful Use Workgroup met on June 16, 2009 and presented their recommendations to the HHS Health IT policy Committee. The Workgroup’s presentation reflects the diverse ideas and contributions from the workgroup members and also builds upon the National Committee on Vital and Health Statistics public hearing that discussed “meaningful use”.

Progressing towards the ultimate goal requires:

  • Using EHRs to make significant and measurable improvements in population health through a transformed healthcare delivery system
  • All patients to be fully engaged in their healthcare
  • Providers to have real-time access to all medical information and tools to ensure quality and safety, to improve access to care, and eliminate healthcare disparities
  • Privacy and security protections to be in place
  • Key information generated in the delivery of care to be digitized

The recommended definition of “meaningful use” will depend on the healthcare setting. Some features and capabilities will be recommended as required in an ambulatory setting before similar functions are expected to be widely used in the hospital. This is due to the availability of the technology in these different settings as well as the potential impact of these features on the health of the population served.

A notice to be published in the June 18th Federal Register, seeks comments no longer than 2,000 words to be submitted by June 26th at 5pm on the workgroup’s draft recommendations for the term “meaningful use”.

Stakeholder feedback is desired as to whether the recommended timeline is overly aggressive based on the current state of technology and the demands on new provider workflows, or not challenging enough to result in significant transformation in light of the declining level of Medicare incentives in future years. In addition, further information on the June 16th meeting is available at

Send comments to, subject line “Meaningful Use”. Written comments may also be submitted to the Office of the National Coordinator for Health Information Technology, 200 Independence Ave, SW, Suite 729D, Washington D.C. 20201. Attention: HIT Policy Committee Meaningful Use Comments.

For additional information including any requests for a hard copy or faxed copy of the draft description, call Judith Sparrow, 202-205-4528, or email

Sunday, June 14, 2009

Help for Rural Colorado

The Colorado Rural Health Care Grant Council awarded $1.2 million in their second round of grant funding to strengthen healthcare delivery in rural communities. “As we continue toward our goal of providing access to high quality affordable healthcare to all Coloradans, it is critical that we support our rural communities”, said Governor Ritter.

For example, there is a serious problem in the state since the prevalence of diabetes is somewhat higher in rural than in urban areas in the state. People in the rural areas of the state tend to be diagnosed later and as a result, receive substandard healthcare as compared to their urban counterparts.

To address rural health issues, the Colorado Rural Health Care Grant program established in 2007, was funded with a $7.5 million gift to be distributed over six years from UnitedHealthcare. The 27 grants in the second round of grants awarded in rural communities ranged from $30,000 to $50,000. The funding went to physical, mental, and oral healthcare providers in 19 counties.

Grantees include Federally Qualified Health Centers, public health departments, public and private health clinics, and school-based health centers. The grants provide funding for health information technology, construction and remodeling, equipment and supplies, and staff training.

The Colorado Rural Health Care Grant Council meets at least annually to monitor the impact and effectiveness of the grant program, and regularly examines eligibility requirements. The Council is co-chaired by Colorado’s Chief Medical Officer, Dr. Ned Calonge, and UnitedHealthcare’s Vice President for Health Care Strategies, Dr. Jacqueline Stiff. The Council includes healthcare consumers, rural healthcare providers, and representatives from the Governor’s Office, Division of Insurance at the Department of Regulatory Agencies, Department of Health Care Policy and Financing, and the Department of Local Affairs.

The Colorado Rural Health Center (CRHC), the state’s non-profit Office of Rural Health administers the grant program. Recently, in February 2009, CRHC was able to open its first regional office to serve southeastern Colorado.

CRHC was able to open the office with a grant from the Colorado Health Foundation and as a result, implemented an “Improving Performance in Practice” initiative in rural health clinics in Southeastern Colorado. The goal for the initiative is to integrate quality improvement and data collection methods into practices, increase efficiency, manage patients through population-based strategies, and expand and sustain improvements to care.

A piece of state legislation the “Colorado Healthcare Affordability Act” (HB09-1293) was recently passed by both the House and the Senate to help to insure over 100,000 people in Colorado and to provide the hospitals with enhanced Medicaid, CHP+ and CICP reimbursement rates.

The bill however creates a “Hospital Provider Fee Oversight and Advisory Board” to oversee the implementation of a fee required in the legislation. However, to help rural areas, the legislation may allow Critical Access Hospitals and rural hospitals to be exempt from paying the provider fee or perhaps pay the fee at a reduced amount.


Monitoring Fetal Heartbeats

Tiny fluctuations in a fetus’s heartbeat can indicate distress, but currently there is no way to detect such subtle variations except during labor, when it may be too late to prevent serious or even fatal complications. Now a new system developed by MIT scientist Gari Clifford and colleagues was designed to make earlier monitoring of the fetal heartbeat possible. Additional researchers working on the project are from the Institut National Polytechnique de Grenoble, Sharif University, Tufts Medical Center, and E-TROLZ Inc.

Among other advantages, the system is expected to be less expensive and easier to use than current technologies. It could also cut the rate of Cesarean deliveries by helping clinicians rule out potential problems that might otherwise prompt the procedure. Finally, the device used today to monitor subtle changes in the fetal heartbeat during labor must be attached to the fetus itself, but the new product being developed would be noninvasive.

One of the methods used today to detect the fetal heartbeat is to use ultrasound but ultrasound is not sensitive enough to catch variations in the heartbeat rhythm that might indicate problems. Another method is to use electrocardiography to record the electrical activity of the heart to catch subtle changes in the heartbeat. However, until now there has been no reliable way to use the technique except by attaching an electrode to the baby’s scalp during labor.

Although it is possible to monitor the fetal ECG signal noninvasively through electrodes on the mother’s abdomen, the signal is weak compared to the maternal heartbeat and surrounding noise. It also has not been possible to separate the three signals without distorting characteristics of the fetal heartbeat key to identify potential clinical problems.

The new system separates the maternal ECG signal from the fetus’s and from background noise due to a complex algorithm derived from the fields of signal processing and source separations. Together these fields work to break any signal into its source components.

To use the system, which the team believes could be deployed during the second trimester of pregnancy and perhaps earlier, a woman would wear a wide belt around her abdomen fitted with several ECG electrodes. The prototype has 32, but that number will be lower in the final device. The data collected from the electrodes is then fed to a monitor and analyzed with the new algorithm which in turn, separates the different signals.

By monitoring the fetal ECG through the mother’s abdomen, you can get a multidimensional view of the fetal heart because its electrical activity is recorded from many different angles. The single probe used now to monitor the heartbeat during labor only gives data from one direction.

Principal colleagues on the signal processing work include Dr. Reza Sameni, Professor Christian Jutten of the Institut National Polytechnique de Grenoble, and Professor Mohammad B. Shamsollahi of Aharif University. The researchers have published papers in several journals.

Clifford’s key collaborator on the clinical work is Dr. Adam Wolfberg, an obstetrician and a fellow in maternal fetal medicine at Tufts Medical Center. To validate the algorithm and build the system, he turned to E-TROLZ. Dr Clifford expects the system to be commercially available in two to three years pending FDA approval.

The original development of the device was funded by the Center for Integration of Medicine and Innovative Technology. Recently several patent applications were licensed by MindChild Medical Inc.

Online Care for Cancer Survivors

The Lance Armstrong Foundation (LAF) and Penn Medicine just announced that they have formed a four year partnership to develop and disseminate the LIVESTRONG Care Plan to be powered by Penn Medicine’s OncolLink. Originally launched as OncolLife on Penn Medicine’s OncolLink website in 2007, this tool is the only one of its kind created and updated continuously by a team of cancer physicians and nurses.

“There are currently 12 million cancer survivors in the U.S. and 28 million worldwide,” said Doug Ulman, President and CEO of the Lance Armstrong Foundation. “The lack of post-cancer medical care leaves a staggering number of people without support.”

The LIVESTRONG Care Plan is taking steps to develop a basic plan that survivors can review and discuss with their healthcare team. The plan will give the oncology team details on a cancer survivor’s therapy such as the type of cancer, where the patient received radiation therapy, facts and details on chemotherapy, and details if the patient underwent surgery as part of the treatment.

The Institute of Medicine researched the state-of-care for cancer survivors and found that there was little guidance that may arise after treatment available for survivors and their healthcare providers. Now cancer survivors, their families, and physicians will be able to create an individualized plan of care using up-to-date treatment information. Also the site will provide education on the options available once the patient is out of treatment.

Specifically, the Institute of Medicine suggests that once a person has completed cancer therapy, they should be able to find information on the potential late effects of treatment, recommendations for cancer screening, psychosocial effects on relationships, recommendations for a healthy lifestyle, genetic counseling, effective prevention options, and a list of resources.

The LIVESTRONG Care Plan program is designed only for survivors of adult cancers. Childhood cancer survivors are not included in the plan since the late effects of their treatment during childhood development have been studied in greater detail and much more is known.

IHIE Improving Quality Care

Unified Group Services a third party administrator is working with the Indiana Health Information Exchange (IHIE) on their Quality Health First (QHF) Program. The program helps physicians and patients achieve better health outcomes and reduce the overall cost of care. Unified is the first third party administrator to participate in the QHF.

“As our newest partner in the Quality Health First program, Unified Group Services is providing its members with a cutting-edge service that brings proactive information to physicians in order to improve the quality of patient care,” said Dr. J. Marc Overhage, President and CEO of the Indiana Health Information Exchange.

The QHF program designed by IHIE and the Employers’ Forum of Indiana, securely delivers patient information such as lab results, medication histories, treatment histories, and other clinical data in a standardized electronic format across all providers.

The QHF service is available at no cost to physicians, enables the physicians to view a list of their patients who are due for preventive screenings and chronic disease follow-up care for diabetes and heart disease, along with mammography, and well-child visits. Currently over 900 physicians have signed up to participate.

As an example of the QHF program in action in the Indianapolis community, the health information exchange platform has found that 30% of area diabetics aren’t receiving timely tests and 35% of women aren’t having timely mammograms.

Telehealth Conference at NIH

A two day event “The Future of Telehealth: Essential Tools and Technologies for Clinical Research and Care” will bring stakeholders to the main NIH campus in Bethesda MD to review the state of telehealth and discuss future opportunities on June 25th and 26th. The National Center for Research Resources (NCRR) within the National Institute of Health is collaborating with Internet2, the American Telemedicine Association, Veterans Administration, and with other federal partners to present this conference and workshop.

The meeting is free and open to the public. Attendees will gather to hear ideas from government agencies, academic institutions, healthcare organizations, and technology companies. The goal is to review the state of telehealth science and technology, identify gaps in knowledge to be addressed through targeted research and evaluation initiatives, and to explore opportunities to leverage information and communication technologies to advance the field.

Interactive panel sessions on the second day will yield specific recommendations to stimulate development, implementation, and evaluation of telehealth applications for clinical care, clinical and translational research, and health education and training, with the ultimate goal to broaden participation in research and to improve health outcomes in medically underserved communities.

For more information and to register, go to Telehealth. For logistical questions or for additional information on registering, contact Monica Barnette at 301-650-8660 or email For workshop content, contact Michael H. Sayre, PhD at 301-435-0962 or email

Wednesday, June 10, 2009

NIH Recives 20,000 Applications

NIH received 20,000 applications for Challenge Grants to be awarded through ARRA funding. This number of applications is equal to the total number of applications that NIH receives in just one of the agency’s three major review rounds each year.

The Challenge Grant program is designed to spur new areas of research and trigger an influx of research dollars into communities. NIH requested applications on topics in broad scientific areas that would benefit from a jumpstart. Some of these areas are bioethics, translational science, genomics, health disparities, enhancing clinical trials, behavioral change and prevention, and regenerative medicine.

The next step is for the Center for Scientific Review (CSR) to check the applications for compliance and review them in a two phase process. Reviewers with expertise in the specialized topic areas have been recruited to do the first phase reviews. Their reviews and applications will be further assessed by one of 30 study sections by researchers who will focus on the application’s overall significance and impact.

All Challenge Grant applications will receive a summary statement containing critiques with criterion scores from three assigned reviewers. More than 18,000 scientists are expected to be involved in the peer review process.

CSR typically reviews 16,000 applications with the help of about 8,000 reviewers in each of the three main yearly review rounds. Including Challenge Grants and other ARRA grants, CSR will assess about 40,000 applications this round with about 28,000 reviewers.

The deadline for the grant applications was in April. Scores and summary statements will be available in August 2009 and the Challenge Grants will be awarded by September 30. 2009.

NIH expects to provide $200 million in ARRA funding to Challenge Grants. In addition to the 200 Challenge Grants to be funded by the NIH Office of the Director, it is likely that more than 200 ARRA related grants will also be funded by NIH Institutes or Centers.

Advancing Health Research

In 1880, Alexander Graham Bell’s first telephone was successful because Bell was able to generate sound from light. Today, with support from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), researchers at the University of Arkansas for Medical Sciences in Little Rock, are using the same principle to create a novel, highly sensitive diagnostic tool that may detect cancer and other disease before they become life-threatening.

This new phone developed by the researchers combines a laser and an ultrasound transducer and enables the researchers to listen for both normal and abnormal cells flowing throughout the lymphatic system. Although researchers know the lymphatic system plays a role in cancer, inflammation, and fighting infections, little is understood about the cellular composition of lymph and how cells move through this network. This research will permit the identification of a wide range of cell types including those related to infection, cancer, and the body’s immune system.

Down the road, this work may allow researchers to use a technique deep in the body to assess deep lymph and blood vessels in organs at risk for disease. The researchers are exploring both noninvasive and minimally invasive approaches for the early detection of stroke, heart attacks, infections, and inflammation. The challenge is to match the right imaging tags or nanoparticles to target cells so that abnormal cells are clearly heard within the noisy cell background.

Clinical trials are expected to move ahead in the next year or two. The trials will first assess cells in blood flow and then move to lymph assessment. When the techniques become clinically available, Viadimir Zharov, Director of the Nanomedicine Laboratory at the university, hopes to provide a combination diagnostic and therapy system.

Dr Zharov continued to say “We should be able to kill disseminating metastatic cells with the same laser that detects the abnormal cells by increasing the energy a little bit. Other applications may include cleansing body fluids of bacteria and viruses and tracking cell reaction to drug therapy and radiation. The assessment of lymph may provide a completely new form of medical diagnostics, however, it won’t be as universal as a blood test, but for some applications, it will be more specific.”

Native Health Surveyed

According to an article appearing in the “Mukluk Telegraph”, the Alaska Native people understand the health needs and the research that the Alaska Native Tribal Health Consortium (ANTHC) should focus on. ANTHC’s Division of Community Health Services (DCHS) in a recent survey asked tribal leaders what they think are the top health research priorities. “It was part of a national Indian Country wide effort to define what the health research priorities are among American Indians and Alaska Natives,” said DCHS Director Tim Gilbert.

The 50 Alaska tribal health leaders who were surveyed tended to agree that cancer concerns easily top the lists. Among those concerns are screening and early identification, treatment, rural access, and causes and prevention.

Following cancer concerns, the other top health research priorities are chronic disease management especially diabetes and cardiovascular diseases, prevention referring to tobacco and drug use, suicide, and domestic violence. Behavioral health issues such as substance abuse and mental health, elder care and oral health are also high on the list.

According to Gilbert, ANTHC has very good research capacity especially when compared to other tribal organizations in the lower 48. However, recent staff turnover has taken place and this has led to examining the research department’s organization and how to streamline efforts.

As a result, ANTHC has reorganized its research team into the Clinical and Research Service Department. Janet M. Johnson, former Senior Epidemiologist with the Alaska Native Epidemiology Center is ANTHC’s new Health Research Director. Johnson said “the goal is to not only conduct research that counts but also to conduct research on what our doctors and nurses need to know and what the people say they need.

Results from the health priorities survey will be available at

Texas Group Receives Grant

Mental Health America of Greater Houston (MHA) received $259,092 in grant funding from the Hogg Foundation to help form a statewide network of healthcare providers with the purpose to expand integrated healthcare to treat people’s health in Texas.

Integrated healthcare is gaining recognition in Texas as a viable way to improve healthcare by treating physical and behavioral illnesses together. The 81st Texas Legislature passed House Bill 2196 that would create a statewide work group to make recommendations on integrating physical and behavioral healthcare in Texas. The bill is now awaiting the governor’s signature.

A person’s physical and mental health can be linked. Chronic illnesses such as diabetes, cancer and heart disease often are accompanied by behavioral ailments such as depression or anxiety. Research has shown that people with severe mental illnesses such as schizophrenia and bipolar disorder die an average of 25 years earlier than people without these disorders. This is largely due to challenges and obstacles in receiving medical treatment.

The problem is that most organizations working on this critical issue are working in silos and sharing little information on lessons learned. Working in isolation leads to a slower pace of change and can inhibit the spread of effective practices.

MHA will work with the foundation during the next 18 months to design, launch and coordinate a statewide learning community. The learning community members will be selected by the foundation through a request for proposals to be issued later in 2009. Members of the community will receive a grant from the foundation to help cover the cost for participation.

Members will work together online and in person to share documents, stories, tools and resources that they have found useful. They will be able to raise questions, discuss issues, and identify potential solutions that may work best for communities throughout the state.

Since 2006, the foundation has funded $2.6 million in grants to promote the practice of integrated healthcare across Texas and in 2008 held a statewide conference on integrated healthcare. Recently, the foundation published a comprehensive overview of integrated healthcare services and research in Texas and the U.S.

The Hogg Foundation founded by the children of former Texas Governor James Hogg, is part of the Division of Diversity and Community Engagement at the University of Texas at Austin. The foundation’s grants and programs support mental health consumer services, research, policy analysis, and public education projects in Texas.

Sunday, June 7, 2009

Leaders Debate Health Reform

Former HHS Secretary Michael Leavitt and Former Senate Majority Leader Tom Daschle appeared before a packed room at the National Press Club on June 2nd to discuss health reform. Mark McClellan Former Administer of CMS, Former Commissioner of FDA, and now Director of the Engelberg Center for Health Care Reform at the Brookings Institution moderated the event. He opened the debate with comments on how the challenges and disagreements on the issues need to be resolved before this country can come up with a workable reform of the healthcare system.

Both Leavitt and Daschle see the urgent need to provide access to the 50 million that now aren’t covered by insurance and for the underinsured. Both also agree that we need to come to terms with the quality of care in the system and deal with cost issues.

Daschle emphasized that the cost of healthcare is escalating and will only get worse in 10 years if we don’t do something now. He pointed out that today, Starbucks spends more on healthcare than coffee—that is a real problem. As Daschle sees it, we have to begin paying for value and away from paying for volume. We can’t equate volume of money spent with the volume of quality care.

Daschle also emphasized that health IT needs to replace our present paper driven system as there will be a real savings over time and provide tremendous benefits. It takes money to create a new infrastructure for health IT but electronic exchange of information can’t be left to the future.

Leavitt agreed that escalating costs are not sustainable and just spending more money will not solve the problem. We have to change how the system works and go from a healthcare sector to developing a true healthcare system. The need to act is now and we need to take real steps to enact payment reform and at the same time develop good wellness and prevention programs.

One area for debate between the healthcare leaders, centered on whether legislation should provide for public options or whether there should be private plans to address healthcare in this country.

According to Leavitt, the government can organize and create a system but must not own the system. At the same time, we need to create an informed consumer group to be actively involved to help make their own decisions. He continued to emphasize that he does not want to see the government run the system as this belongs in the private sector.

Daschle wants to see the government offer its own insurance plan and provide a framework for good consumer choices. He doesn’t want to deny the people choice, but he feels that in this way government can provide for more people to be covered and receive care.

Both Daschle and Leavitt are not too optimistic on comprehensive legislation passing. However, Leavitt thinks some form of legislation will pass since the President and Congress feel compelled to move ahead on this issue. He does see the expansion of Medicaid and quality issues being addressed. Daschle on the other hand is a little more positive and feels there is a 50-50 chance that something will pass since President Obama is providing his leadership and direction to push health reform forward.

ARRA Funding Posted

NIH posted new Funding Opportunity Announcements supported by ARRA. The first funding announcement (RFA-OD-09-008) seeks grant applications for a new initiative called “Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies” (BRDG-SPAN) pilot Program. This new pilot program uses a new mechanism called the RC1.

The purpose for this pilot is to address the funding gap between promising R&D and the time it takes to transition to the market. This funding gap is often referred to as the “Valley of Death”. The funding will help to transition research innovations and technologies toward developing products or services for the marketplace.

NIH is committing at least $35 million for these grants. It is anticipated that at least ten awards will be made in FY 2010. Funding priority will be given if the project is thought to have high commercial potential to be developed into a product or service as indicated by the underserved and their needs.

This program is open to any U.S. for-profit enterprise or commercial organization and applications may be given funding priority if the applicant is associated with a small business organization with 500 or less employees.

For more details on RFA-OD-09-008, go to or

The second posting (RFA-OD-09-009) referred to as the “Recovery Act Limited Competition: Small Business Catalyst Awards for Accelerating Innovative Research” uses the SBIR Phase 1 activity code. This program is looking for grant applications from small businesses that are interested in accelerating innovation through high risk and high reward R&D with commercial potential.

Applications from small business concerns without a history of NIH SBIR/STTR support may receive funding priority. NIH seeks early stage ideas that represent advancement in a technological area that promises to lead to major leaps forward and not merely incremental improvements of existing technologies. Projects can involve research tools techniques, devices, inventions, or methodologies.

NIH plans to commit at least $5 million in response to this project in FY 2010 to fund 20-25 grants. Both applications for funding were posted on June 2, 2009 and are due September 1, 2009. Letters of intent are not required but encouraged and must be submitted by August 3, 2009.

For more details on RFA-OD-09-009, go to or In order to submit applications for NIH funding, it is necessary to register in both and eRA Commons.

DARPA Releases Plan

The Defense Advance Research Program Agency (DARPA) released their Strategic Plan in May 2009. DARPA’s Bio Revolution program has several major programs. One of the projects involves making advances in biological warfare defense. DARPA is working to shrink the time when a pathogen enters the body and the time it takes for researchers to produce millions of effective vaccines/therapeutics. The goal is to do this in 16 weeks or less.

DARPA researchers are able to identify the DNA of a pathogen that is operational. The next step is to find the weak spot in the pathogen where a therapy can be directed. Instead of trying to find one target for every new pathogen and then developing a therapy for each, DARPA has found common targets among many different pathogens and can identify common therapies to take out the whole classes of pathogens. While there is no silver bullet to take out all pathogens, there has been substantial progress. This technique identified a single target weakness common to Ebola, cowpox, and influenza.

DARPA has also developed approaches to dramatically increase the effectiveness of vaccines. One agent, CpG, has been shown in some cases to reduce the dose required to achieve immunity and the number of booster shots needed to maintain immunity. With CpG, DARPA has demonstrated a nearly nine fold improvement in response to the anthrax vaccine and has significantly shortened the time when soldiers will have full protection from anthrax. CpG is in advanced clinical trials for influenza and biodefense vaccines.

DARPA’s Rapid Vaccine Assessment program is working on new ways to test vaccines. Now DARPA is able to model the human immune system using a high throughput automated system. This platform significantly reduces the time, expense, and risk involved with pharmaceutical and vaccine development by providing human clinical trials in a virtual test tube.

This technology will enable rapid screening of candidate vaccines within weeks instead of years and allow vaccine manufacturers to improve vaccine safety and effectiveness before beginning clinical trials. DARPA’s Accelerated Manufacturing of Pharmaceuticals program is producing technology for large-scale manufacturing.

DARPA is making a major effort to help improve the chances for the wounded to survive battlefield injuries by developing advanced combat casualty care technologies. One project is using simple automated ventilators suitable for the combat medic. Existing field ventilation devices needed to be operated by hand, sometimes requiring medics to make a terrible choice between continuing to help someone breathe or leave that person to treat other casualties. DARPA’s Simplified Automated Ventilator Portable Ventilator program has developed an automated “Ambu Bag” that combat medics can use in the field that is simple to operate, safe, rugged, and inexpensive.

DARPA’s Preventing Violent Explosive Neurological Trauma (PREVENT) program is a basic research program looking for the mechanisms of neurological injury particularly traumatic brain injuries caused by blasts. PREVENT will scientifically characterize and understand how blasts cause neurological injury and the cumulative effects on the brain from repeated small blasts. Once this is understood, protective technologies can be designed to protect the soldiers.

Another major effort is to develop new materials, processes, and devices that are inspired by living systems to enhance military systems. DARPA is letting nature be a guide toward better engineering. DARPA is working to devise a machine that could come close to the brain’s ability to recognize visual patterns. The NeoVision2 program is working to understand the mammalian visual pathway and the brain activity and then mimic it using state-of-the-art microchip designs in silicon-based devices.

DARPA is always working on projects to improve and maintain peak soldier performance. One project involves using a new simple technology to both cool down troops who have become overheated, and warm up troops who have become chilled. The Rapid Thermal Exchange Device is a special glove that uses the blood vessels in the palm of the hand to transfer warmth to or from the bloodstream.

Another issue is to reduce pain for the injured or wounded soldiers. DARPA is developing biodegradable self-regulating drug delivery systems to enable feedback regulated release in response to biomarkers correlated with drug efficacy and/or toxicity. This will enable therapeutic doses to be given while eliminating the possibility of overdoses.

DARPA is also working to restore combat capabilities after severe injuries. Research is ongoing to restore the function of complex tissue, such as muscle, nerves, and skin, after traumatic injuries on the battlefield.

DARPA’s flagship prosthetics program is heavily invested in improving prosthetic arms that can be directly controlled by the brain. Progress has been made and clinical trials are already underway at Walter Reed and Brooke Army Medical Centers. Full clinical trials with completely neutrally controlled prosthetics with functions almost identical to natural limbs are scheduled to begin in two years.

In addition to the major efforts to obtain maximum results for soldiers, DARPA has also initiated the Bio-Info-Micro program. The program has been developing synergies among biology, information technology, and micro and nanotechnology to bring together science and technology from these areas to produce new capabilities

To read the full report, go to

Rural Health Bill Introduced

The “Rural Health Quality Advisory Commission Act” was introduced on May 21st by Representatives Stephanie Herseth Sandlin from North Dakota and Greg Walden from Oregon. The legislation creates an expert Rural Health Quality Advisory Commission to implement a national plan to improve rural health quality and to identify strategies to eliminate gaps in the rural health system capacity.

Representative Herseth Sandlin said, “The establishment of the Commission will ensure that the differences between care in urban and rural areas are appropriately recognized and that national quality measures ensure access to quality healthcare.”

While the majority of healthcare quality improvement tools can be applicable equally in urban and rural areas, experts have found that there are also differences. For example, a quality measure applicable in an urban setting may address conditions that are not often treated or procedures that are not commonly performed in small rural hospitals. Plus procedures and processes such as triage, stabilization, and transfer of patients can be particularly important in rural hospitals.

The legislation authorizes $30 million to create the Commission and to design and implement five demonstration projects to evaluate methods to improve the quality of healthcare in rural communities. The Commission would use the information gathered from the demonstration projects to make national recommendations based on lessons learned.

Each demonstration project would need to address safety and effectiveness for patients in the community. Attention would need to be given to workforce support, quality monitoring and reporting, clinical care protocols, and information technology applications. Healthcare providers and delivery systems in rural areas and rural research centers are eligible to apply.

Wednesday, June 3, 2009

Providing Mental Healthcare

The wars in Iraq and Afghanistan have taken a toll on the mental health resources available to troops in the Air Force. The number of men and women who need help with mental health issues outweighs the number of available Air Force psychiatrists.

The Air Force and the University of Nebraska Medical Center UNMC) have formed a partnership so that medical center psychiatrists will be able to provide servicemen and women help via telehealth technology. The problems the troops present range from PTSD to depression and substance abuse. The university has sought congressional funds to start this program.

The UNMC Department of Psychiatry will take the lead and James Sorrell, M.D., Associate Professor of Psychiatry will head the effort. “Ultimately this project will help meet mental health needs in the state since the difficulties faced by the military and rural communities are very similar. Both have high demands for psychiatric services and have critical provider shortages. Lessons learned will enable us to provide cutting edge psychiatric and behavioral care to underserved communities in rural Nebraska.”

The telepsychiatry services will be offered regionally to personnel on Air Force bases in Nebraska, Oklahoma, and Wyoming, as well as on bases in Korea and Japan. In addition, UNMC and the Air Force are working on developing portable devices as small as a Blackberry to help deliver care.

In another move to help service members with mental health issues, the Air Force has introduced virtual reality-based software to help service veterans combat Post Traumatic Stress Disorder (PTSD). The software is now being used at eight Air Force bases to help create a safe environment to help veterans with PTSD.

This new Virtual Reality (VR) technology compliments the evidence-based treatment called “Prolonged Exposure Therapy” plus it helps service members successfully integrate their deployment experiences into their concept of themselves and face other challenges.

The VR treatment for PTSD also helps soldiers deal with their deployment in a way they can control. By focusing on their experiences, they are able to bypass the anxiety that sometimes comes from having to do strictly face-to-face talking therapy.

The individual undergoing treatment uses a head mounted display similar to a pair of sunglasses which has separate screens for each eye and a head tracking device. The display is then connected to a computer graphics workstation that introduces sights and sounds designed to make them feel like they are in a situation such as on patrol in the city or driving a Humvee. There is even a vibrating platform and a mock M16 instead of a typical game controller to more successfully engage the person in the experience.

During the therapy session, the person describes the trauma they are experiencing in detail to the therapist. They verbally recall everything they can to the therapist in the present tense such as sights, sounds, smells, thoughts, and feelings. The therapist then recreates the scene for the individual to experience, and during the session, the therapist has the person rate their overall distress at several points. The individual will go through the same scenario several times until they are able to process the memory and view the experience differently.

It is ideal for individuals who find it difficult to engage in visual imagery, who have patchy or clouded memories, who may have blacked out during their trauma experience, or who are unable or unwilling to experience the full range of anxiety and distress they felt when traumatized.

NIST to Award up to $35 Million

The National Institute of Standards and Technology (NIST) will be awarding research grants to support specific focus areas. The focus for the research will be on energy, environment and climate change, information technology, cybersecurity, biosciences/healthcare, manufacturing, and physical infrastructure as part of NIST’s activities under ARRA or the Recovery Act. All proposals must be received by July 13, 2009.

The goal is to spur technological advance in science and health that will provide for long term economic benefits. Reviewers will consider how the work will help to advance measurement science and engineering in current and future NIST programs. Applicants may propose projects that include collaboration between scientific staff and NIST.

NIST plans to award up to $35 million in grants and cooperative agreements with 20-60 awards expected. Individual awards are expected to range between $500,000 and $1,500.000 with projects to start by September 2009.

This program is open to universities, non-profit organizations, commercial organizations, and state, local, and Indian tribal governments.

For more information, go to or to the June 1, 2009 edition of the Federal Register. For questions, contact Jason Boehm at or call (301) 975-455.

Georgia's Innovative Projects

Four of Georgia’s leading research and healthcare organizations have joined together to create an innovative new center to accelerate the development and commercialization of next generation medical devices and medical technology. The Global Center for Medical Innovation (GCMI), the first of its kind in the Southeast, will include a comprehensive medical device prototyping center and be able to manage, coordinate, and aggregate intellectual property from partner organizations and interested private companies.

The center is supported by the Georgia Institute of Technology, Saint Joseph’s Translational Research Institute, Piedmont Healthcare, and the Georgia Research Alliance. The new center will bring together a complete medical device marketplace to include universities, research centers, clinicians, drug and device companies, investors, and early stage companies. The Center will be located adjacent to the Georgia Tech campus.

“The convergence of the life sciences with engineering provides a unique opportunity to expand our technology in areas that will support the healthcare industry of the future,” said G.P. “Bud” Peterson, President of Georgia Tech. “GCMI will bring together in one location, the key infrastructure needed to rapidly move new medical devices and new medical technologies to market”.

Georgia Tech has also started a new research center to find ways to heal and treat wounds with funding provided by the Armed Forces Institute of Regenerative Medicine, the Army Institute of Surgical Research, DOD, and from private industry. The research focuses on using a person’s own stem cells to build up tissue and to repair bones with the hope that the cells will take hold and more tissue and bone will be able to repair and grow. The timeframe is to start clinical trials in 3 years.

Also in Georgia, two of the leading vaccine research centers will combine their expertise to establish an international research program leading to the development of new human vaccines for infectious diseases and cancers.

The Emory Vaccine Center will collaborate with the Australian Centre for Vaccine Development at the Queensland Institute for Medical Research in a new Queensland and U.S. Vaccine Technology Alliance funded in part by a three year grant from the Smart Futures of the Queensland National and International Research Alliance.

Other plans are for Emory University to establish a new Emory Institute for Drug Discovery to focus on commercially neglected diseases, global health partnerships, and mentored research. The center will be led by scientist and entrepreneur Dennis Liotta, PhD, who co-invented drugs taken by more than 94 percent of HIV/AIDS patients in the U.S.

Governor Sonny Perdue has also announced the launch of the first-of-its-kind research tool called iResearchGeorgia. This online free database is the only one in the U.S. that combines the research capabilities of multiple public and private universities within a single state. Users of the database will be able to search and explore published papers, patents, on more than 500 faculty profiles and NIH grants associated with Georgia’s researchers.


On May 29th, NIH Posted a Request for Applications (RFA-HD-09-017) looking to develop or improve new devices and instruments to help monitor and treat newborn infants and small children safely. The applications are due on July 31, 2009.

Devices and instruments developed to use for sick infants needs to be based on sound bioengineering principles. Despite major advances in biotechnology, research and development efforts have been limited at introducing new and innovative pediatric devices and instruments.

This may be due to the lack of collaboration between the clinical and bioengineering scientific communities to develop such devices. Collaborations between clinical and bioengineering research communities in the field of pediatric device development need to take place. This RFA seeks researchers to collaborate to develop these new devices or to improve existing devices and instruments.

There are several Institutes within NIH that are supporting the research work. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is supporting four applications with $900,000, the National Heart Lung and Blood Institute (NHLBI) is supporting two applications with $450,000, the National Institute on Deafness and Other Communication Disorders (NIDCD), the National Center for Research Resources (NCRR), and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDKK) are each setting aside $225,000 to support one application each submitted to their Institute.

All small businesses are eligible to respond. The RFA uses the SBIR grant mechanism and runs in parallel with an RFA that seeks applications under the STTR program. For more information, go to or go to

Enabling POC Diagnostics

The Third Annual Enabling Point-of-Care Diagnostics Conference will present a unique opportunity to network with life science executives attending the August 10-11, 2009 meeting at the Ritz Carlton Hotel in Washington D.C. Listen to experts in the field discuss how information provided at the point-of-care can be done efficiently to provide disease management effectively.

Attendees will hear Mark N. Blatt M.D. Director, Healthcare Industry Solutions, Digital Health Group, Intel Corporation discuss new clinical and business trends that are empowering clinicians in the developed world to provide care directly to the home.

Craig Lehmann, PhD, Interim Executive Dean of the Health Sciences Center, Dean of the School of Health Technology and Management, and Professor of the Clinical Laboratory Sciences at Stony Brook University, reports that of the 58 million deaths in developed and developing countries, approximately 35 million will be a direct result of heart disease, stroke, cancer, chronic respiratory diseases, diabetes and is expected to increase by 17 percent in the future. His presentation will discuss the use of e-health and point-of-care technology in community health environments in the U.S. and in Kenya.

When point-of care is needed to provide disease management, Becky Clarke, Executive Vice President, Telco will detail how to effectively transmit data, integrate the data, and then communicate the data to clinicians.

The next generation point-of-care Closed Unit-Dose Assay (CUDA) will be described by Richard Lee, PhD, Senior Manager, Development, Gen-Probe, Inc. The platform uses actuator-driven fluidic movement to perform a complete sample-to-result molecular diagnostic assay in one hour.

Case studies in disease management will be presented on day two. Joseph M. Campos, PhD, Director, Microbiology Laboratory, Molecular Diagnostics Laboratory and Laboratory Informatics, at Children’s National Medical Center, and a Professor at George Washington University Medical Center, will present case studies that illustrate the value of point-of-care testing in the hospital environment.

New Products, new companies, and new technologies will be on display. Thomas Lowery PhD, Director of Research, Assay Development, at T2 Biosystems, will discuss a next generation point-of-care diagnostic platform that the company has pioneered. The compact universal detection platform is able to demonstrate sensitive measurements of DNA, proteins, and many other target analytes. Because of the magnetic-based detection system, the usual interference in optical assays does not occur. This unique combination of technologies allows for a multiplex and multi-analyte (DNA and protein) system to rapidly quantify biomarkers on dirty samples.

The “Enabling Point-of-Care Diagnostics meeting is part of the Cambridge Healthtech Institutes Premiere “Next Generation Dx Summit” Other meetings offered the same week at the Ritz Carlton in Washington D.C. include Trends in Cancer Diagnostics, Molecular Diagnostics for Infectious Diseases, and Clinical Adoption of Next Generation Diagnostics, plus there will be several Pre-Conference Symposiums.

For more information, go to To register, go to or email , or telephone (781)-972-5400 Option 1.