Sunday, February 6, 2011

Monitoring Drugs for Safety

The drug-approval process is known for its rigorous standards on safety and effectiveness, but even with pre-market clinical trials involving thousands of people, it can’t possibly uncover everything about a drug’s performance that may occur when used by a larger and diverse population.

Presently the FDA’s adverse Event Reporting system relies primarily on voluntary, spontaneous reporting of suspected drug safety issues by health professionals, patients, and consumers. The Observational Medical Outcomes Partnership (OMOP), a public-private partnership was initiated to help improve the monitoring of drugs for safety and to help develop an approach that is systematic, proactive, and cost-effective.

OMOP draws on the expertise and resources of the pharmaceutical industry, academic institutions, non-profit organizations, the FDA, other federal agencies, and is funded and managed through the Foundation for the National Institutes of Health (FNIH).

The goal for OMOP is to use databases with patient medical records and health insurance claims in order to detect and evaluate drug safety issues over time. The partnership is conducting a two year initiative to find feasible and useful methods to use to analyze existing healthcare databases. By using the database information, researchers will be able to identify and evaluate safety and benefit issues of drugs already on the market.

J. Marc Overhage, M.D. PhD, Director of Medical Informatics and Research Scientists at the Regenstrief Institute and Professor of Medical Informatics at Indiana University School of Medicine, speaking as a OMOP Research Investigator, gave a review of the OMOP Experiment at the OMOP Symposium held January 11, 2011.

He explained how a traditional study would conduct an analysis to estimate the association of one drug—one outcome contained in one database—at one point in time. What is envisioned is a national active surveillance system that will be able to do ongoing monitoring of any medical product and any health outcome of interest across all of the databases in the network at any time.

According to Thomas Scarnecchia, Executive Director for FNIH, longer term research plans are to expand OMOP’s methods program to a broader array of medical products to include medical devices, and biologics. The plan is also to expand methods program beyond product safety along with available computational resources.

OMOP is seeking collaborators to work on their 2011 Research Plan. Opportunities are available through FNIH grants, contract project work, and partnerships. For example, on January 12, 2011, OMOP released a “Request for Application” seeking researchers to collaborate on “Methods Research” with OMOP. The procurement is open to any researcher or organization with awards anticipated to be $50,000 to $250,000.

The due date for the RFA is February 14, 2011 with the award date scheduled for February, 28, 2011. For more information on the RFA, email Emily Welebob at welebob@omop.org. For general information on the OMOP program, email Thomas Scarnecchia at tscarnecchia@fnih.org.

DOD Releases STTR 11.A Solicitation

The Department of Defense is currently seeking STTR (N11.A) proposal submissions. The STTR program is funded at over $100 million dollars annually with six components, including the Army, Navy, Air Force Missile Defense Agency, DARPA, and Defense Research & Engineering. The response to the STTR (N11.A) solicitation is due March 30, 2011.

The STTR program is similar to the SBIR program but the STTR funds cooperative R&D projects that can place a small business and a research institution together to work on research more effectively in order to move ideas from research institutions to the marketplace.

To participate in the STTR program, a firm must be a U.S. for-profit small business of 500 or fewer employees, the research institution must be a U.S. college or university, the small business must perform a minimum of 40 percent of the work, and the small business must manage and control the STTR funding agreement.

The Navy issued the specific solicitation (N11A-T033) to find a way to have naval personnel use a wearable recording device to capture, synchronize, and download environmental, physiological, physical, and capable of looking at subjective measures that can contribute to physical and cognitive fatigue.

Currently, the Navy has increased their operational capability but the Navy is forced to do this with a reduced number of warfighters. Since there is less personnel, it is essential to accurately predict the Navy’s warfighter’s performance and then know how their performance ranks with others. This can be accomplished more effectively by using hardware and software, as opposed to just using just human capabilities with resulting limitations.

Presently, the Navy does use human performance models such as Total Crew Model and IMPRINT but even though today’s performance models are good, they still lack the fidelity to support tradeoff analyses. Also, most models are not validated and have little capability to account for the impact of environmental stressors such as fatigue, motion, vibration, and extreme temperatures.

A significant challenge in validating human performance models is the ability to collect environmental and performance data from warfighters and other naval personnel in an operational setting. Current methods are primarily paper-based and the process of coding self-reported responses is time consuming and increases the likelihood of errors in data entry.

Therefore, to overcome the data collection challenges associated with validating human performance and to ensure an accurate account for the effects of environmental stressors on performance, a novel, integrated, non-obtrusive data collection and analysis system is greatly needed.

The Navy anticipates that sensors will be used for data collection and it has been shown that recent advances in individualization algorithms are making possible a whole new generation of systems capable of tailoring mathematical and model-based assessments with capabilities to determine the fatigue level of differences among Naval personnel and operators of equipment.

The Navy realizes that academia and industry are increasingly developing portable and wearable data collection technologies. For example, services such as the iPod touch have the capability to obtain subjective responses. However, none of the devices or technologies developed so far are able to collect information non-obtrusively and then have the capability to incorporate this data with environmental, physiological, physical information and subjectively be able to measure fatigue existing in on the job.

Go to www.acq.osd.mil/osbp/sbir/solicitations/sttr11A/navy11A.pdf then go to (N11A-T033) to view the solicitation.

The responsibility for the Navy’s STTR program is with the Office of Naval Research. The Navy STTR Program Manager is Mr. Steve Sullivan and he can be emailed at steven.sullivan@navy.mil.

For general questions regarding (N11A-T033) with the title “Multi-Sensor Data Collection Suite for Unobtrusive Human Performance Measurement”, contact June Chan at navair.sbir@navy.mil.

For technical questions about the topic before February 28th, contact Amy Bolton at amy.bolton@navy.mil or phone (703) 588-2547 or contact Igor Vodyanoy at igor.vodyanoy@navy.mil or phone (703) 696-4109. After February 28th, go to the DOD web site at www.acq.osd.mil/sadbu/sbir.

Wednesday, February 2, 2011

HIT for Patient Care Supported

The Markle “Survey of Health in a Networked Life” is the first survey to compare the core values of physicians and patients. The survey shows that both doctors and patients overwhelmingly agree on health IT priorities to improve patient care and that health IT will increase the quality, safety, and cost efficiency of care, as well as provide core privacy protections.

“A surprising 74 percent of doctors say they want to be able to share patient information with other professionals electronically. As medical professionals shift from paper records to electronic systems, the public and physicians overwhelmingly agree that we need to measure the payoff from investments in information technology in terms of better health and more cost-efficient care,” according to Markle President Zoe Baird.

“Roughly 80 percent majorities of both the public and doctors agree that it is important to require participating hospitals and doctors to share information to better coordinate care, cut unnecessary costs, and reduce medical errors,”, said Carol Diamond, MD, Managing Director of the Markle Foundation, a New York based nonprofit foundation.

“By the same overwhelming margin, four in five doctors and patients expressed the importance of privacy protections for online medical records, an expectation we have repeatedly found expressed by the public in our previous surveys. They also agree on the importance of measuring progress,” said Diamond.

Majorities of 70 percent to 80 percent of both patients and doctors support letting people see if their records have been accessed, patients being notified if they are affected by information breaches, and giving people the mechanisms to correct information if needed.

Of the doctors surveyed, 94 percent said their patients sometimes forget or lose track of potentially important things they are told during doctor visits, and 34 percent of the doctors said they themselves at least sometimes forget or lose track of potentially important things that their patients tell them. Among the patient group, 30 percent perceived that their doctors forget or lose track of potentially important information at least sometimes.

Among the public, 10 percent reported having an electronic Personal Health Record (PHR) which is up from 3 percent who reported having a PHR in Markle’s 2008 survey. “Past surveys show that most adults believe personal health records should include copies of their own medical information to help them improve their health and communicate better with health professionals,” reports Josh Lernieux, Director of Personal Health Technology at Markle.

He said, “This survey indicates that there is an increase in PHR use and also that roughly two out of three doctors agree that patients should have the option of online access to their personal health information.

Knowledge Networks (KN) conducted the surveys August 10-26, 2010. The general population survey of 1,582 adults age 18 and older used KN’s KnowledgePanel®, a probability-based panel of 50,000 individuals designed to be representative of the U.S. populations. The survey of 779 physicians was conducted using KN’s Physicians Consulting Network (PCN), an invitation-only list of more than 45,000 practicing physicians.

Results of the survey are available at www.markle.org.

Personalized Medicine & HIT

The question is how do we handle the enormous influx of genetic and medical data plus financial information and then incorporate this data into medical histories. In the future, personalized medicine will offer better targeted treatments, provide for health system cost savings, and help produce a better understanding of care options.

The 21st century healthcare model will use technology to incorporate information into large databases. By using this massive amount of information, medical professionals will have many ideas and choices as to what types of therapies will work for specific people.

A Brookings event held on January 28, 2011 brought forth discussion and ideas on the challenges involved in handling enormous amounts of data and properly utilizing IT to meet future health needs. Darrell West, PhD, Founding Director of the Center for Technology Innovation (CTI) at Brookings and Vice President and Director of Governance Studies, centered the discussion on the just released CTI paper “Enabling Personalized Medicine through HIT”.

Experts in the field such as David Brailer MD, PhD, Chairman, Health Evolution Partners and the first health information czar during the Bush Administration, Mark Boguski Associate Professor, Center for Biomedical Informatics, Harvard Medical School, Emad Rizk MD, President, McKesson Health Solutions, Donald W. Rucker, MD, Vice President and Chief Medical Officer, Siemens Medical Solutions, and Paul Billings MD, Chief Medical Officer, Life Technologies Corporation all offered their valuable ideas and thoughts on the subject.

Dr. Brailer started the discussion by saying that the public does not really recognize or understand the value and benefits of combining health IT and personalized medicine but enormous benefits would result. The health community could use genetic information to shape diagnoses, genetic testing could be used to enlighten patients on what their tests really mean, physicians would be provided with even more knowledge on the patient then they already have, and this in turn, would reduce or prevent unnecessary tests and provide for better treatments.

As Dr. Boguski pointed out, patients want to take an active role in their healthcare and be empowered patients. This means that in order for medicine to move forward, patients have to be co-managers of their healthcare.

Some of the challenges and issues discussed by the panel regarding the incorporation of personalized medicine into clinical practices would mean:

• Reshaping privacy and security needs since privacy is always a concern when combined with genetic information. A 2009 Institute of Medicine report concludes that the HIPAA Privacy Rule does not do the job and calls for a new approach to privacy

• Demonstrating the value of integrating personalized medicine into the payment systems. It is very important to emphasize the value of personalized medicine and this has to be demonstrated to CMS

• Interoperability will be even more important since a tremendous amount of data from many different sources will be incorporated into data bases. This means that as more and more information is available on diseases and treatments, even larger data sets will be needed so that interoperability will be an even more important factor than it is today

• Handling the documentation on tests from laboratories will greatly increase since 70 percent of clinical decisions are based on laboratory information. This means that in the future, pathologists will play a bigger and more important role which will necessitate that the profession be upgraded

• Enabling people to use social media to spread medical and health information to where it needs to go. Although today, many people use social media, it is still underutilized for medical data. Social media could be an invaluable asset to get information circulated worldwide on rare diseases

• Making certain that electronic health records play an important role in connecting genomic, other personalized information, plus drug information to genetics. EHRs with the right coding information could not only link treatment information with outcomes, but could also provide reimbursement based on the end result.

• Developing differentiated billing codes for various molecular or genetic conditions and tests so that researchers will be able to link genomic information to disease diagnoses and treatment

• Reducing the isolation of health research and genetic research information since this valuable information will need to be introduced into medical records and clinical practices

• Producing decision support tools especially for younger providers. HHS hopes to add decision models to the last stage of providing incentives to providers

Go to www.brookings.edu/papers/2011/0128_personalized_medicine_west.aspx to view the CTI report “Enabling Personalized Medicine through Health Information Technology.

Review of VA's 2010 Performance

The VA's new initiatives along with their current ongoing programs has contributed to turning the VA into a 21st century organization that is people-centric, results driven, and forward looking. VA programs and activities have increased in rural healthcare, telehealth, upgrading the benefits system, providing for more transparency, and developing a new competition to find solutions to problems.

In the area of rural health, the VA continues their Rural Mobile Health Care Clinics pilot program. In addition, the VA supports studies and analyses on a wide range of healthcare issues relevant to rural and highly rural veterans. Specifically, studies on how to implement telehealth, how to address the unique needs of the Native American population, and how to treat the many older veterans in the VA system are ongoing.

In total, the VA telehealth program has expanded by 30 percent in providing home telehealth services. The program provides care to Veterans with chronic medical and mental health conditions, and today, the program enables 46,000 veteran patients to receive care and live independently in their own homes and local communities.

To help in the area of health IT and to increase efficiency in delivering healthcare, the Department of Defense and the VA are in the process of establishing a Virtual Lifetime Electronic Record (VLER) to provide seamless and efficient access to the information needed to provide services and benefits.

The goal is for DOD and the VA to exchange information between their different systems and their points of service in the private sector. To move the project faster from concept to implementation, the VLER initiative has been divided into two major lines of business such as health and benefits.

The implementation of this system will eventually allow for a standards-based information exchange between the health information systems of the two departments and the private sector. A series of pilots are underway to produce a scalable approach that will deliver the initial capabilities required by the end of calendar year 2012 with the implementation to be expanded to a mature state by the end of calendar year 2014.

The VA’s benefits information system is also undergoing an incremental implementation approach. Today, the current VA and DOD benefits information-sharing mechanisms are being evaluated and will be developed to provide basic administrative information in a seamless format between the departments by the end of calendar year 2012 and by 2014. At that time, access will be established to retrieve all of the necessary administrative information between the departments as well as relevant and accessible information in the private sector.

The VA was directed to develop a specific and actionable plan to be more transparent, participatory, and collaborative to meet the needs of the Administration. Some of the changes include the submission of 30 data sets to Data.gov, the collaborative development and soft launch of the “Blue Button enabling veterans to download their personal health records, and the imminent delivery of the Fast Track system for automated claims process of presumptively service-connected disabilities.

A new program, the VA Innovation Initiative (VAi2) was launched in 2010 to identify, prioritize, fund, test, and deploy the most promising solutions to VA’s most important challenges. The program invites employees, private sector companies, entrepreneurs, and academic leaders to contribute their best ideas for innovations. Innovations are needed to increase the veterans’ access to services, improve the quality of services delivered, and/or enhance the performance of VA operations. In 2011, VAi2 will continue to provide oversight to more than 50 projects initiated in 2010 to ensure their implementation

The VA also recently established the Technology Acquisition Center (TAC) in Monmouth, New Jersey. The TAC is a strategic department asset providing acquisition support for the VA’s Office of Information Technology. During 2010, TAC awarded over $478 million in contracts and developing an effective procurement strategy to support VA’s major initiatives.

Improving Rural Healthcare Delivery

Blue Cross Blue Shield of North Dakota awarded seven grants for $375,000 to provide health technologies to improve healthcare delivery in rural communities. The Rural Health Grant Program administered by the Center for Rural Health at the University of North Dakota School of Medicine and Health Sciences will administer the grants.

The seven grants will go to:

• Hospice of the Red River Valley of Fargo will use the funds to implement software that will improve communication and care coordination between rural and urban providers across the entire hospice patient care experience

• Catholic Health Initiatives of Fargo will use the funds to fully integrate two-way video support in emergency rooms of four critical access hospitals. The telehealth technology will provide round-the-clock access to emergency care specialists

• St. Alexius Foundation of Bismarck will use the grant to buy telehealth equipment to monitor patients daily that are diagnosed with chronic diseases in their homes after a hospital discharge

• Ye Olde Medicine Center of Park River will use the funds to expand the Park River telepharmacy services to Drayton North Dakota

• Wishek Hospital Clinic Association of Wishek will use the grant to support the implementation of electronic medical records in two critical access hospitals

• St. Andrew’s Health Center of Bottineau on behalf of Northwest Alliance for Information Technology (NWAIT) will use the funds to expand data storage capacity to enable 10 rural hospitals that make up NWAIT to expand and maximize their electronic health records and shared patient information

• Garrison Memorial Hospital of Garrison will use the grant funding to implement ECG units in community Memorial Hospital and 3 clinics. The units will test results that are transmitted over a secure wireless connection to be viewed by on-call cardiologist at the St. Alexius Medical Center

For more information go to http://ruralhealth.und.edu/projects/bcbs or email Lynette Dickson, Program Director, Center for Rural Health at lynette.dickson@med.und.edu.

Spotlight on mHealth Conference

mHealth Initiative’s 3rd “mHealth Networking Conference” will be held March 30-31, 2011 at the Crowne Plaza Chicago O’Hare Hotel & Conference Center. The focus for the Conference will be on mHealth strategies, clinical and patient communications such as texting and email, mobile apps, along with information on provider, pharma, and payer opportunities.

Attendees at this Conference will learn how mHealth is redefining quality of care expectations, presenting marketing advantages, and providing for clinicians effectiveness. Attend to find out about the latest developments and to discuss hurdles and experiences with others.

The Conference will highlight and explore:

• The adoption rate, successes, and failures for new medical apps on mDevices
• How payers are addressing mHealth opportunities
• The movement toward prescribing apps
• Integrating mHealth applications and best practices
• mHealth strategies for hospitals, clinics, or doctor’s offices
• Patients role in moving providers toward mHealth communications
• International implementations
• Many more topics to come

The Conference will provide an enormous opportunity to network with users, C-level execs, implementers, government agencies, vendors, developers, payers, and many others.

Interested in speaking? The call for presentations deadline is January 10, 2011. Interested users, implementers, and planners including consultants are encouraged to submit their ideas online.

To learn more about this vital up-to-the-minute conference on mHealth or to register, go to www.mobih.org or email meetings@mobih.org.

Book your room at the Crowne Plaza Chicago O’Hare Hotel & Conference Center for the special conference rate of $145 for a single or double.

For information on exhibiting and sponsorships, contact Beth Schrager at bschrager@comcast.net or call (978) 263-9931.

To contact Claudia Tessier RHIA, President mHealth Initiative, call (617) 816-7513 or email Claudia@mobih.org.