Software Patent Status

The competition for market share in high value sectors like smartphones and tablets is nothing new according to David Kappos Under Secretary of Commerce for Intellectual Property and Director of the U.S Patent Office. He was speaking an event at the Center for American Progress in Washington D.C. held on November 20^th.

 “Devices can have many patented components and features and contain a blend of software, hardware, and design patents. Yet software patents have tended to be the focus of controversy and some critics go so far as to say that software shouldn’t be patentable at all. It is very important that patent protection be properly tailored in scope so that programmers can write code and engineers can design devices without fear of unfounded accusations of infringement.”

In his remarks Kappos said, “This administration understands that low-quality patents aren’t good for anyone. The work to establish patent quality was helped in 2010 when the Patent Office rolled out a complete broad objective patent quality measurement system to include seven metrics reported to the public. These metrics show that the Patent Office’s decisions on both allowances and rejection correctly comply with all laws and regulations over 96 percent of the time.

In 2011, the Patent Office published their first comprehensive guidelines for review of claim clarity which is an issue that comes up regularly with software patents. The 112 Guidelines have measurably improved the clarity of patents in the software area. In fact the Patent Office’s nine month review of the guidelines showed more than a 20 percent increase in rejections even though an increased number of issues have been resolved through 170,000 hours of interviews conducted with patent applicants in the last year.

Kappos also mentioned how the Patent Office has reached out to experts in the software industry to provide technical training to patent examiners, so that they are up to date on the latest developments. More than 17,000 hours of technical training was provided in FY 2012 alone, including 32 software-related courses presented by academic and industry experts. Now outreach will be even easier since the Patent Office has established a Silicon Valley satellite office.

The field has not only made progress through court decisions, but the Patent Office reexamination process is another method for challenging software patents. The reexamination process has proved to be an effective tool in weeding out invalid patents with much less expense and disruption than litigation.

An important step was taken when most of the final rules for America Invents Act (AIA) were implemented. Kappos said, “The AIA is the most significant reform to the U.S. patent system since 1836. Many of the provisions are well suited to software patents.

The Patent Trial and Appeal Board helps manufacturers, service providers, and patentees confirm the validity of issued patents while rejecting overly broad ones. The procedure called post-grant opposition allows third parties to challenge an issued patent on any ground including basic eligibility and clarity. The result is that the cost of pursing a post-grant proceeding with the Patent Board is far cheaper than challenging a patent in court.

Fresh legislation suggestions are currently circulating. Some people believe the Patent Office should have more tools to review existing software patents and many believe that all software patents should be included.

A legislative proposal circulating would try to curb speculative patent suits that extract settlements based on borderline frivolous infringement claims. The SHIELD Act legislation introduced in Congress earlier this year, seeks to deter law suits by requiring the loser of an infringement case to pay court costs and attorney fees for the winner.

Beyond legislation, Kappos explained that there are gaps within the regulatory system that still need to be addressed. One problem for software patents is simply deciphering ownership. Sometimes, it can be a real challenge for those facing a possible infringement suit to determine the owner of the patent that they may be infringing.

This is especially true in the software area where innovation is extremely diverse and broad based among large and small entrants everywhere and where patent applications and patents are frequently bought and sold. The completeness of the patent record including ownership is essential to a functioning innovation market.

Securing Hand-Held Devices

 Sandia National Laboratories located in California is researching how to prevent and mitigate disruptions to computer networks on the internet specifically concentrating on smartphones and other hand-held computing devices.

Sandia cyber researchers have linked 300,000 virtual hand-held computing devices that run on the Android operating system so they can study large networks of smartphones and find ways to make them more reliable and secure. Androids dominate the smartphone industry and run on a range of computing gadgets.

The main challenge in studying Android-based machines is the sheer complexity of the Google software. Google developed the Android operating system and wrote some 14 million lines of code into the software. According to researchers, working with that amount of code, it is possible for something to go wrong on the scale of a big wireless network because of a coding mistake in an operating system or an application which can be very hard to diagnose and fix.

The research is expected to result in a software tool that will enable others in the cyber research community to model similar environments and be able to study the behaviors of smartphone networks. Ultimately, the tool will enable the computing industry to better protect hand-held devices from malicious intent.

The Android project dubbed “MegaDroid” is expected to help researchers at Sandia and elsewhere who struggle to understand large scale networks. In the near future, Sandia expects to complete a sophisticated demonstration of the “MegaDroid” project to present to potential industries or government collaborators. Much of Sandia’s work on virtual computing environments will be available for other cyber researchers via open source.

Sandia’s researchers see the possibility of extending the technology to other platforms besides Android. For instance, Apple’s iOS could take advantage of the toolkit under development. Researchers also plan to use “MegaDroid” to explore issues of data protections for specific agencies such as DOD and the Department of Homeland Security.

Highlighting Biomedical Innovation

Mark McClellan MD, PhD, Director of the Engelberg Center for Health Care Reform opened the Brookings Institution event “New Policy Directions for Biomedical Innovation” November 19^th in Washington D.C. by saying that biomedical innovation has made medicine more precise and produced safer treatments that have added to the length of life.

However, as he pointed out that there are challenges restricting innovation that includes a strained fiscal environment that puts limits on research. More financial resources will enable more good ideas to develop and make it possible for biomedical science and innovation to be beneficial and affordable for the entire population.

Keynoter Ed Penhoet Director Alta Partners recently appointed to President Obama’s Council of Advisors on Science and Technology (PCAST) discussed PCAST and the Committee’s report to the President on “Propelling Innovation in Drug Discovery, Development, and Evaluation”. The report is available at www.whitehouse.gov/administration/eop/ostp/pcast/docsreports.  PCAST has not yet been able to brief the President on the Report but is planning to do in the near future.

According to the report, clinical trials constitute the largest single component of the R&D budget of the biopharmaceutical industry at approximately $31.1 billion representing nearly 40 percent of the R&D budget of major companies. The PCAST report stresses the need for industry, the Federal Government, academic researchers, and the medical community to work collectively to create efficient clinical trial networks and trial designs.

The report recommends that FDA improve tools for monitoring and communicating clinical benefits and risks. FDA should strengthen capabilities for post-marketing surveillance, and Congress should authorize line-item appropriations of $40 million per year to expand FDA’s Sentinel System. FDA should work with stakeholders to develop new tools to effectively communicate risks and benefits to patients and the broader public.

Next, a panel on “Finding the Path Forward for Biomedical Innovation” that included senior thought leaders participated in a discussion on actionable steps needed to improve biomedical innovation.

Panelists want to see more funds for research, more of a focus on translational and collaborative research, improvement in the speed of clinical trials, development of safer drugs, increase the role of the patient in drug development and have the patient play a more active role, better coordination across FDA, develop advance analytics and IT, and make better use of national language processing and machine mining.

Panelists included:

·        Christopher Austin, Director, National Center for Advancing Translational Sciences

·        Debi W. Brooks MBA, MS, Co-Founder and Executive Vice Chairman, for the Michael J. Fox Foundation

·        Robert Conley MD, Regulatory Leader and distinguished Lilly Scholar, Eli Lilly and Company

·        John Mendelsohn MD, Director of the Khalifa Institute for Personalized Cancer Therapy at the University of Texas MD Anderson Cancer Center in Houston

·        Earl P Steinberg MD, MPP, Executive Vice President of Innovation and Dissemination and Chief of Healthcare Solutions Enterprise at Geisinger Health System

Go to www.brookings.edu/events/2012/11/19-biomedical-innovation to view a video of the event.

Children with Special Needs

Researchers are helping neurologically impaired children overcome their mobility challenges and explore their environments by providing them with specially designed toy cars according to a National Science Foundation (NSF) newsletter article.

The NSF team outfitted low tech ride on cars with high tech mechanisms inspired by power wheelchairs and robotic technologies. Children’s use of the cars shortened developmental delays and reduced other disability-related problems associated with lack of age typical motor skill development.

Children with down syndrome, spina bifida, cerebral palsy, or autism often suffer limited mobility from birth. Power wheelchairs may become available to them when they reach the age of four or give but until then many children can be nearly immobile which can result in adverse effects on brain development.

In 2007, professors at the University of Delaware developed a robotic car that incorporated a joystick and smart technology and also has software to detect obstacles and help the user learn to navigate around them. Users showed an increase in cognitive language and motor skills. In 2010, the prototype was converted into a dual power chair and walker.

At first, high end robotic cars were available to only a few children at the university’s Early Learning Center while parents of other special needs children anxiously awaited the technology.

In response to the parent’s interest, the team transferred some of the electrical and mechanical modifications to a low tech commercially available race car. Even with the less sophisticated cars, children with special needs still enjoyed some developmental benefits from enhanced mobility.

The researchers plan to introduce a prototype in 2020 that will feature smart technology and a more efficient body structure. They are also testing a dynamic harness to allow children to experience safe walking and falling.

Telemedicine to Train Officials

Video satellite technology and the latest medical techniques are used to train military surgical teams for war, triage patients in earthquake-ravaged Haiti, and provide help for other high profile projects. The Trauma Telemedicine Team of the William Lehman Injury Research Center at University of Miami’s Ryder Trauma Center is taking another bold step in the field.

Led by Antonio Marttos, M.D, the Trauma Telemedicine Team is training Brazilian Medical officials to establish an integrated trauma system for the 2014 World Cup and 2016 summer Olympic Games.

Mattos and his team gained experience by treating the athletes at the recent Summer Olympics in London, where they established a pilot telemedicine program linking all the Brazilian athletes to their headquarters. No matter where they were competing, every injured athlete was assessed immediately via smart phones and tablets to determine the best treatment and connect them to a specialist if necessary.

Brazilian officials chose the Miller School program based on its considerable experience in the field of trauma telemedicine. The Ryder Trauma Center is home to the Army Trauma Training Center, which trains forward surgical teams that operate overseas. In addition, telemedicine provided medical support to injured survivors of Haiti’s devastating 2010 earthquake.

In preparation, teams of physicians and nurses from Rio de Janeiro have started training at the Ryder Trauma Center, where telemedicine facilitates connect medical teams from different sites. The 17 member team from Brazil spends two weeks at Ryder and includes six surgeons, three anesthesiologists, one intensive care specialist, one pediatrician, and six nurses. The back and forth travel and training is slated to continue for nearly four years.

To provide the care for the 2014 World Cup and the 2016 Olympic Games, Rio de Janeiro will be building five trauma centers. The Centers are to be fully integrated and use telemedicine to manage the care of injured athletes and other patients.

Rio de Janeiro state hospitals will be linked using telemedicine to include Alberto Torres, Albert Schweitzer, Adao Pereira Nunes at the new Rocha Faria, and the new Trauma Hospital in the Metropolitan, the highest density location of the Rio state. Trauma teams will consist of general, vascular, orthopedic, and neurosurgical specialists as well as anesthesiologists, pediatricians, thoracic, and urologic trauma surgeons.

VA Secretary Submits Report

Telehealth based clinical services grew by 66 percent in the last two years according to a report submitted by Secretary of Veterans Affairs Eric K. Shinseki on November 15^th to the President and Congress. The report “Performance and Accountability Report” points out that in 2012, the VA greatly improved veterans’ access to telemedicine and mobile clinics and effectively treated six million patients.

This year, the VA used $250 million to support projects designed to increase access and quality of care for rural and highly rural veterans. These projects include rural expansion of home-based primary care and mental health services, support for new rural clinics, and rural veteran outreach through a project referred to as “Project Access Received Closer to Home” (ARCH). Also, the VA partnered with academic affiliations to issue an RFP to develop and implement interdisciplinary rural health training and education programs at five VA sites.

In 2012, 497,342 veteran patients received 1,429,424 telehealth based care delivered from 150 VA Medical Centers and 750 Community Based Outpatient Clinics (CBOC). Also in 2012, the VA expanded home telehealth services by 31 percent, expanded clinic-based telehealth services by 42 percent, and achieved 39 percent expansion with 76,817 veterans receiving clinical video telemental health from 146 VA Medical Centers and 531 CBOCs. New services are expanding in teleradiology, teledermatology, telepathology, audiology clinic support, tele-intensive care, and women’s health services.

The VA has developed and deployed more than 300 IT applications and uses IT to improve access and improve processing claims. One major initiative, Disability Benefits Questionnaires (DBQ) use streamlined forms designed to capture medical information that veterans can provide to private doctors. As a result, there are more timely rating decisions, fewer duplicated examinations, and reduced need for exams.

The VA has implemented the second phase of the pilot study for their Private Medical Records (PMR) initiative. The PMR initiative uses the services of a contractor to obtain private medical records associated with veterans compensation and/or pension claims. The private medical records are scanned into the virtual VA document repository. To date, there have been more than 2.1 million pages scanned.

So far, the Virtual Lifetime Electronic Record (VLER) has impacted thousands of veterans and service members by piloting HIE through NwHIN at 13 sites and by sharing over 3 million medical records through the Bidirectional Health Information Exchange and Clinical Health Data Repository. In addition, the use of automated information management and sharing between DOD and VA supports the Federal Recovery Coordinator Program and Integrated Disability Evaluation System.

The VA has been working with social media. Over the past year, the VA implemented Facebook pages for every VA medical center to reach over 109,000 veterans and families at a local level. The Department also uses Twitter to reach over 121,000 veterans each day and Flicker and YouTube have been accessed 2.5 million times since adoption in 2009.

To advance treating veterans with mental health issues, VHA has trained over 4,000 VHA mental health providers on one or more evidence-based psychotherapies for PTSD and/or other mental health conditions. In addition, due to VHA’s expansion of telemental health, veterans can now receive the same level of care regardless of location or proximity to a VA medical center.

The VA has revamped and expanded polytrauma care for veterans by signing a $52 million construction contract for a new polytrauma center in Tampa, opened a new facility in San Antonio, and continues to operate state-of-the-art centers in Minneapolis, Richmond, and Palo Alto. 

Go to www.va.gov/budget/docs/report/2012-VAPAR_FullWeb.pdf to view the entire report.

HRSA Spotlights Grantee

Hunter Health Clinic Inc., a non-profit community health service located in Wichita Kansas is a HRSA and Indian Health Services (IHS) grantee. Hunter specializes in caring for those who are uninsured and under insured. The Clinic provides medical care, dental services, optometry, mental health counseling, and substance abuse services across five sites.

At the same time, the Clinic serves as a training center for over 180 students, interns, residents, and volunteers. In 2011, Hunter provided over 84,000 patient encounters and saw 33,840 patients where 70 percent were uninsured and 80 percent had incomes below the federal poverty level.  

Hunter went live with their EHR in 2009 and has successfully tracked quality measures to improve healthcare quality and patient outcomes. Hunter uses the IHS Resource and Patient Management System (RPMS), a decentralized, integrated solution for the management of both clinical and administrative information. RPMS features hardware, software, a network, and a database all of which work together.

Hunter uses RPMS to support their government reporting requirements. Currently, Hunter routinely reports on 13 required measures. By generating these indicators in real-time, through the use of their RPMS, Hunter has been able to identify successful interventions resulting in measured improvement and has rapidly identified areas for improving preventive care. The clinic has been able to improve their stage 1 Meaningful Use core measures through the use of RPMS to better capture the information reported in the EHR.

Hunter has been using their EHR system to help care for patients with diabetes. The Clinic operates a free standing diabetes specialty clinic as a complement to their primary care services. The diabetes team has two clinicians, a foot specialist, a dietician, diabetes educators, nurses, an optometrist, and an outreach coordinator that provide comprehensive diabetes management. The clinic also supports a diabetes-specific medication program, laboratory services, and preventive dental care for patients with diabetes.

Through the use of the EHR, the optometrist is able to monitor the ocular health of the patient and schedule appointments when new symptoms are noted or if too much time has elapsed since the patient’s last visit. Also, when the optometrist suspects that a new patient may have diabetes, the patient can generally be seen in the clinic the same day.

Being able to see how the technology benefits patients has made it possible for the staff at Hunter to see the value of health IT. Hunter plans to join the Wichita Health Information Exchange and Kansas Health Information Exchange to enable them to share data with other providers across the state.

PCORI Announces Funding

The Patient-Centered Outcomes Research Institute (PCORI) on November 16^th released a funding announcement to address methodological gaps in research. PCORI plans to award $12 million for up to fourteen contracts to study knowledge gaps and how this lack of knowledge is affecting the advancement of the field of comparative clinical effectiveness research.

PCORI is an independent, non-profit organization authorized by Congress in 2010. PCORI’s mission is to fund research that will provide patients, caregivers, clinicians with the evidence-based information needed to make better informed healthcare decisions. 

According to PCORI Executive Director Joe Selby, MD, “Our goal is to improve this research field by building data infrastructure, improve analytic methods, and train researchers, patients, and other stakeholders to participate effectively when conducting research.”

This PCORI Funding announcement is part of PCORI’s fifth priority area “Accelerating Patient-Centered and Methodological Research”. It is the first of a number of funding announcements PCORI expects to issue in conjunction with this specific priority.

“To improve the quality and effectiveness of care, we need evidence-based information that patients can trust and use,” Selby said. “Developing strong, rigorous patient-centered research methods has the potential to transform our ability to provide patients and caregivers with the information they need to take care of the patient.”

Go to www.pcori.org/funding-opportunities for application materials. The online application system is open and letters of intent are due January 15, 2013. Awards are expected to be announced in the spring of 2013.

Technology Under Development

Emory University received a grant from NIH under the STTR program to fund research and develop new technologies that have the potential to succeed as commercial products. Dr. Muralidhar Padala, Director of Emory’s Structural Heart Disease Research and Innovation Laboratory in collaboration with MedShape Solutions Inc. an Atlanta medical device company are working to develop a polymeric heart valve.

The problem is that Bioprosthetic Heart Valves (BHV) used since the 1980’s to repair valves can deteriorate over time due to calcification. While mechanical valves fail less frequently than BHV, they can create problems such as blood clots. In recent years, the search for a more durable artificial heart valve has turned to the development of the biocompatible Polymeric Heart Valve (PHV).

NIH funding will help Dr. Padala and his team develop a new PHV using a novel ultra-polymer called polyetheretherketone or (PEEK). “PEEK is superior to traditional polymers and is widely used for implantable devices,” says Dr. Padala. “It has excellent fatigue resistance, low water absorption, highly inert structure, is likely to be hemocompatible. Its structures can be molded into complex shapes and woven and/or non-woven to avoid regions of stress concentration which is where structural failure of BHV occurs.”

In other news, Neurotrack, an early stage company has launched a breakthrough technology developed by a team of researchers at Emory to diagnose Alzheimer’s disease years before clinical symptoms appear.

Based on results from a 5 year longitudinal study funded by NIH, this computer-based recognition memory test has been able to predict Alzheimer’s at least three to four years before clinical symptoms appear with 99 percent accuracy.

“One of the biggest hurdles that pharmaceutical companies face in the development of preventive drugs for Alzheimer’s disease is populating their clinical trials with appropriate candidates that are pre-symptomatic but who have Alzheimer’s disease,” said Elizabeth Buffalo, PhD, Associate Professor of Neurology at Emory.

“Unlike other diagnostic tools on the market, Neurotrack’s test focuses on memory ability that critically depends on the integrity of the hippocampus, one of the first areas of the brain that is affected in the course of Alzheimer’s,” said Stuart Zola, PhD, Professor of Psychiatry at the university. “Our hope is that this tool will allow us to determine who is on the trajectory for Alzheimer’s and then be able to intervene at a time when the brain is less compromised.”

Another research project at Emory involves developing a home diagnostic test for Anemia. Anemia is the most commonly recognized blood disorder that requires blood tests to be done.

Due to the nature of the blood draw, this type of test is not appropriate for home testing or self-monitoring purposes.

However, there are a number of groups including nursing home residents, pregnant patients, patients undergoing chemotherapy, patients with rheumatoid arthritis, and HIV patients that could benefit from a home or over the counter kit for detecting anemia. Similar testing kits currently available are expensive, inaccurate, and difficult to use.

Emory investigators have created a disposable test kit with a color change indicator to monitor hemoglobin levels easily at home. The kit consists of a thin capillary tube, a microfuge-like tube with a chemical solution, and a reference card.

The key benefits for using the disposable kit is that it is a standalone product and does not require electrical power or an additional device to interpret results, requires less than a drop of blood from the patient, and results are available in one minute.

For more information on the kit, go http://emoryott.technologypublisher.com/technology/11404. The “Point-of-care, Patient-Operated, Self-Contained Disposable at Home Diagnostic Test for Anemia” has a prototype in development.

CHCF Invests in iRhythm

The California HealthCare Foundation has invested $1.5 million in iRhythm Technologies the developer of the Zio® Patch ambulatory cardiac rhythm monitoring system. The Zio Patch is a diagnostic service that can be initiated at the point-of-care and worn for up to 14 days.

The continuous recording by the Zio Patch can help identify, or rule out arrhythmia in patients with transitory symptoms and possibly eliminate unnecessary visits to specialists. The Zio Patch has been used on more than 85,000 patients throughout the U.S.

“iRhythm’s Zio Patch technology has the potential to increase access to timely diagnosis and care for patients in both rural and urban environments,” said Margaret Laws, Director of the Innovations for the Underserved Program at CHCF and Manager of the CHCF Health Innovation Fund. “The simplicity of their approach to ambulatory cardiac monitoring minimizes logistical difficulties, promotes increased patient compliance, and streamlines the process for patients and clinicians.”

CHCF is also planning to fund studies at two California safety-net hospital systems to research levels of patient and provider satisfaction, cost effectiveness, and diagnostic efficacy related to the iRhythm solution.

The CHCF Health Innovation Fund invests in sustainable, scalable business models with the potential to significantly lower the cost of care or improve access to care for underserved populations. Other investments have been made with Asthmapolis, CareInSync, Direct Dermatology, Lifewave, Pipeline Healthcare and STRUM.

Challenges Affecting Communications

The FCC has announced plans to hold a series of hearings to examine new challenges affecting the nation’s communications networks in the wake of Superstorm Sandy. The hearings will make recommendations on actions to take to improve network resiliency.

The hearings will look at what communications service providers, state and local officials, emergency personnel, and consumers faced before, during, and after Superstorm Sandy as well as after other natural disasters.

Basically, the hearings will look at what is needed to connect people more effectively to each other and to information in emergencies whether they use mobile, landline, satellite, broadcast, cable, or social media. The plan is also to examine any laws or regulations that may need to change so that disruptions to communication services won’t occur in a future crisis or weather event.

The field hearings will ask a number of questions such as:

·        Did service providers use portable cell sites to reduce the effects of the storm?

·        How can service providers work together to share resources?

·        What level of service is needed and expected during emergencies and for what modes of communications?

·        What technologies, actions, practices, or requirements should be considered to help improve the availability of power?

·        What obstacles face emergency help and what technologies and actions might help?

·        Has the introduction of broadband technologies into commercial communications networks made them more or less resilient to major weather events?

Beginning in early 2013, hearings will take place throughout the country in locations that have experienced major natural disasters, starting in New York. The participants in the hearings will include businesses, public safety officials, engineering and academic experts, consumers, and other stakeholders.

For more information, go to www.fcc.gov.

House Receives Update on HIT

The House Science, Space, and Technology’s Subcommittee on Technology and Innovation held a hearing November 14^th to review federal activities promoting the interoperability of HIT. Farzad Mostashari, M.D., ScM, HHS National Coordinator for HIT one of the witnesses appeared before the Subcommittee to discuss the progress HHS is making to develop an effective health IT system in the U.S.

He reported that as of September 2012, more than 300,000 eligible professionals as well as over 75 percent of eligible hospitals have registered to participate in CMS incentive programs. Also, as of August 2012, Regional Extension Centers (REC) have assisted over 135,000 primary care providers. More than 40 percent of all primary care providers are working with RECs with over half of those providers caring for patients in rural areas.

He discussed how implementing Stage 1 meaningful use requirements was helpful in developing Stage 2. The final rules for Stage 2 were published in September and represent an important next step to help doctors and hospitals use and exchange electronic health information. Stage 3 requirements will focus on health outcomes by improving quality, safety, efficiency, and clinical decision support tools.

Mostashari also discussed how ONC engages other Federal agencies and stakeholders including NIST in developing standards for health IT. NIST’s main focus has been on developing the key standards that the ONC needs for current and future Meaningful Use criteria.

Charles H. Romine PhD, Director of the Information Technology Laboratory at NIST, also appearing before the House Subcommittee pointed out that each standard, test, and test tool developed by NIST, strengthens the infrastructure needed by ONC to certify systems to the Meaningful Use Stage 2 criteria.

To support the ONC testing program, NIST is working with Standard Development Organizations (SDO) and others in areas such as electronic prescribing and public health. NIST is working with the National Council for Prescription Drug Programs (NCPDP) and the American National Standards Institute (ANSI), an accredited standards organization responsible for the SCRIPT ² standard used to send new prescription requests to a pharmacy.

NIST’s staff is working with NCPDP to ensure the NIST-developed conformance test tool and test procedures cover the required elements necessary for compliance to the implementation guide (standard) NCPDP developed.

For future ONC requirements, NIST is providing technical leadership in evolving standards for interoperable EHRs as well as medical devices, genomics, imaging, text retrieval, and analysis, and semantics. ONC has worked with NIST on issues of measuring and improving the usability of EHR products.

Experts from NIST participate on the Health IT Policy Committee that makes recommendations on policy to support the nationwide health information infrastructure.  NIST experts also serve on the Health IT Standards Committee responsible for making recommendations on standards, implementation specifications, and certification criteria.

In addition, NIST works through the Standards and Interoperability Framework, to provide a forum for stakeholders to be able to identify and resolve standards-based issues that may be impeding progress in the marketplace.

Pennsylvania Creating HIE

In May 2012, HealthShare of Southeastern Pennsylvania (SE-PA) invited 18 technology vendors to respond to a Request for Information (RFI) to begin the process to create a Healthcare Information Exchange (HIE).  The state was awarded $17.1 million under ARRA to establish the HIE.

Vendors invited to participate in the RFI were selected based on their experience with similar HIEs to include state and regional HIEs solutions in other nearby states. The national HIMSS interoperability showcase was also used to select the list of vendors. HealthShare’s Vendor Selection Committee for the RFI was comprised of members of the local hospital, health insurance committees, and neutral third party stakeholders to HealthShare.

On August 9^th, HealthShare of Southeastern Pennsylvania gave RFI respondents the list of vendors invited to participate in the RFI, information on the evaluation process, and the list of six technology vendors selected to continue in the vendor selection process. The RFI was then closed and transitioned to the RFP process. The RFP release will be followed by scripted product demonstrations with selected vendors in the fall timeframe. 

The RFP offers respondents the opportunity to refine their previous responses to HealthShare’s RFI as well as address added requirements around their proposed technical solution and their ability to evolve from DIRECT to a robust exchange.

The respondents also need to express their support for Meaningful Use requirements especially with regard to interfacing with State HIE and Public Health entities, address Health Share’s desired implementation timeline, and provide innovative approaches related to the financial sustainability of services.

In the first week of November, the HealthShare Exchange Board passed bylaws for the non-profit organization to establish a health information exchange in Southeastern Pennsylvania, The bylaws call for a full board of up to 15 members, with hospitals and health systems holding five seats.

In addition, Pennsylvania laboratories are positioned to move forward with electronic health information exchange. The state eHealth Collaborative released a study that showed most laboratories operating the state are capable of sending test results electronically.

According to the study, most labs are exchanging information using either a web portal or a hub with small number using point-to-point exchange. Most labs have more than one delivery method available to them.

Also the study showed that while laboratories are exchanging information electronically, most of the responding laboratories were not familiar with the broader concept of an HIE. Thirteen percent of the laboratories surveyed stated that they did not plan to move to the electronic exchange of lab results. The reasons given included cost, lack of technology expertise or interest, and concerns about privacy and security.

New Ideas to Treat Epilepsy

The Epilepsy Therapy Project a nonprofit organization works to accelerate new therapies for people living with epilepsy and seizures. They have just announced that their second annual “Shark Tank” Competition is inviting entries representing the most innovative new ideas in epilepsy treatment and care.

Ideas are needed for a drug or device that stops seizure, a system that helps patients manage their treatment or epilepsy, a device that prevents personal injury from a seizure, and any other concept that could improve the lives of people with epilepsy.

The winner of the competition will receive national recognition and a $100,000 cash award to support the development and commercialization of a new product, technology, or therapeutic concept. The deadline for submission of a Letter of Intent is January 15, 2013.

The top finalists will present their product concepts or therapeutic candidates at the Antiepileptic Drug and Device Trials (AEDD) XII Conference in Miami on May 15-17, 2013.  The expert panel of judges and audience members representing industry, patient advocacy, investment, research, and medical communities will then choose the winner of the “Shark Tank” Competition.

Last year, the winner of the 2012 “Shark Tank” Competition was Charles Anderson of HiPass Design for his Smartphone Movement Detector, a life-saving seizure alarm system that detects and records night-time seizures. Anderson created his movement detector when he found existing solutions were inadequate for alerting him to his son’s seizures. Anderson’s grant funding is supporting the development and commercialization of this seizure alarm which is now in trials.

For more information, go to www.epilepsy.com/etp/aedtrialxii/sharktank or email sharktank@epilepsytherapyproject.org.

NIAID's Award & RFA

NIH’s National Institute of Allergy and Infectious Diseases (NIAID) on November 15^th awarded Johns Hopkins University a “Patient Safety Monitoring in International Laboratories (SMILE) contract for $24,820,549. Currently, SMILE supports approximately 150 non-U.S. laboratories in 19 countries. SMILE will continue to support laboratories that are part of current and future NIAID sponsored clinical trial networks. 

Clinical laboratories in the U.S. are required to meet Clinical Laboratory Improvement Amendments (CLIA) performance standards and participate in a variety of external proficiency testing programs.

However, non-U.S. accreditation organizations and providers of proficiency testing programs exist that vary significantly in their requirements and the level of oversight for clinical laboratories. The purpose of the contract is to evaluate initial and on-going laboratory capability and readiness to carry out NIAID-funded clinical trial protocols.

One of the goals is to maintain a computerized data management system and document library that will include lab performance data and guidance documents. During the course of the contract, additional specialized expertise may be needed to enhance existing computer software systems to accommodate documents similar to those managed by SMILE or received from other NIAID laboratory support.

If the Government elects to exercise this option during the contract, than the contractor will need to provide additional full time equivalent employees with expertise in software development and support. 

The period of performance will be for one year beginning November 2012 and will go through November 2013. The original RFP- (NIAID-DAIDS-NIHA12011-129) was posted December 1, 2011. The contract award number is HHSN272201300004C.

For more information, go to www.fbo.gov.  The primacy point of contact is Ashley Virts at virtsa@mail.nih.gov.

On November 9, 2012, NIAID posted RFA-AI-12-055 titled “Limited Competition: Collaborative Partnership to Advance Global Biomedical Research Programs” Applicant organizations or institutions must have the infrastructure and capacity to extend NIH related research programs internationally.

One of the goals is to establish the infrastructure to help implement and successfully maintain NIH related successful worldwide biomedical collaborations. The focus is to make research findings available globally to facilitate global utilization of research findings, be able to coordinate evidence-based improvement in health, and assess and evaluate health-related programs focused on not only biomedical research but also on public health.

Eligible applicants many include institutions of higher education, non profits other than institutions of higher learning, for-profit organizations to include small businesses, governments, and others.

NIAID intends to commit $100,000 directs costs in FY 2012 to fund one award. A letter of Intent is due December 18, 2012 with applications due January 18, 2013.

Go to http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-12-055.html for more information.

Therapists and Licensing Issues

States exhibit a number of differences in licensing requirements and laws that mental health professionals currently face when practicing distance medicine such as telehealth in another state. As mental health therapy via telehealth is becoming more common, many questions are being directed to individual states.

Issues involved in providing telehealth services are confusing. The different state policies that exist could possibly be clarified by incorporating national guidelines from national associations or draft regulations could be used to clarify an individual state’s policy on using telehealth services.

In California, currently, a licensee in another state may not counsel an individual in the State of California unless they hold a California license. If the client is not located in California, the client’s state has jurisdiction. The California Board of Psychology under the Department of Consumer Affairs wants to have guidelines issued that are in line with the policies of other states.

Other states have other rules. For example, the Massachusetts Office of Consumer Affairs and Business Regulation licenses mental health professionals in the state. However, currently there is no language in statute or regulations that specifically discusses therapy performed via telehealth.

However, the state licensing board has adopted a policy guideline to address questions about the practice of telehealth. The policy states that therapy via electronic means is considered to occur in both the location of the client and location of the therapist.

Therapy for clients located in Massachusetts falls under the jurisdiction of the licensing board regardless of the location of the therapist.  This means that if the therapist is not licensed in Massachusetts and the client is located there, then this would be an unlicensed practice.

The policy encourages Massachusetts licensees who would like to perform telehealth services to a client in another jurisdiction then check the practice requirements in the jurisdiction where the client is located.

The Washington State Department of Health licenses mental health counselors, marriage and family therapists, and social workers. Currently, the department does not have specific clarifying regulations, but is looking at the regulations in other states as a possible model.

The state requires providers to be credentialed in the state in where they provide services, and if the client is located in another jurisdiction, they advise the licensee to contact that jurisdiction for guidance. At this time, when a licensee inquires about telehealth they are told that they must meet all disclosure and confidentiality requirements. They would also recommend the licensee use an encrypted computer program for online therapy.

Mental health practitioners in Ohio are regulated by the Ohio Counselor, Social Worker, and Marriage and Family Therapist Board. The Ohio Administrative Code (OAC) requires practitioners providing services in Ohio to be licensed in the state. They also require an Ohio licensee who is providing services to a client outside of Ohio to comply with the laws and rules of that jurisdiction.

The OAC specifies that the licensees providing telehealth service must use encrypted methods of service delivery, must have an initial face-to-face meeting with the client which may be via electronic communications, licensees must identify an appropriately trained local professional to provide crisis intervention for the client if needed, and the client needs to be given the telephone numbers of the local crisis hotline and local emergency mental health hotline.

The Arizona Board of Behavioral Health Examiners licenses mental health professionals in the state where mental health services are assumed to take place in the jurisdiction where the client lives. The state does have some exemptions to licensure that a behavioral health professional from another state who wants to perform services in Arizona may want to use.

A non-resident is exempt from licensure if the person performs the services for no more than 90 days in any year, licensed to perform those services in the state or country where they reside, and they must inform the client of the limited nature of the services and that they are not licensed in Arizona.

The Arkansas Board of Examiners in Counseling requires a counselor or a marriage and family therapist licensed in the state who wishes to perform counseling via electronic or technology-assisted mediums to obtain a “Technology-Assisted Distance Counseling or Marriage and Family Therapy Specialization License.” This specialization requires specific training approved by the board.

Any telehealth counseling that occurs in Arkansas whether by an Arkansas counselor or an out of state counselor is considered to occur in Arkansas and the practitioner must hold a valid specialized license.

The Arkansas Board of Examiners has adopted the National board of Certified Counselors document “The Practice of Internet Counseling” as part of the rules to clarify standards related to counseling via telehealth. This document defines various types of counseling and outlines standards for the ethical practice of internet counseling.

Wireless Health Solution Launched

Qualcomm Life Inc a subsidiary of Qualcomm Technologies showcased their wireless healthcare services business in Europe at the International Telecare & Telehealth Conference held in Birmingham England. Mobile health holds significant potential in Europe to defray healthcare costs and increase the quality and quantity of care. This will help to address anticipated shortages of qualified healthcare professionals.

Qualcomm Life’s 2net™ Platform and Hub are designed to enable medical device manufacturers and service providers to wirelessly connect their medical devices via a secure cloud-based solution. This enables biometric information to be easily accessible by device users, their healthcare providers, and caregivers. The technology makes biometric information easily accessible by device users, healthcare providers, and caregivers.

Two of Qualcomm Life’s first European customers are Telbios and Cystelcom. Telbios is a leading service provider of remote health monitoring solutions for chronic care and disease management in Italy. By connecting to the 2net Platform, Telbios will be able to combine data from several devices into one data stream to allow for improved access and sharing of patient data. Cystelcom a Spanish engineering software company has developed their mHealth Alert remote monitoring system to help patients dealing with chronic diseases.

Globally, Europe has the highest burden of chronic disease and the continued increase in prevalence is considered an epidemic by the World Health Organization which estimates chronic diseases will claim the lives of 52 million in the European region by 2030.

“There is a clear imperative for health services providers and manufacturers to invest in remote monitoring solutions to improve patient outcomes and align with preventive care initiatives. Europe’s governing bodies have demonstrated a commitment to robust pilots such as the 3 Million Lives project sponsored by the Department of Health in the U.K,” said Laurent Vandebrouck, Managing Director of Qualcomm Life Europe.

For more information, go to www.qualcomm.com. For information on Telbios go to www.telbios.com and for Cystelcom go to www.cystelcom.com

Streamlining ER Information Flow

AHRQ awarded the University of Texas Health Science Center at Houston (UTHealth) a four year $1.9 million grant titled “Opportunistic Decision-Making, Information Needs, and Workflow in Emergency Care”. The goal is to study how to make sure that the right information gets to the right people at the right time, reduce information overload, and test how state-of-the-art EHRs can be used to improve access to data.

The study led by Jiajie Zhang, Ph.D. Interim Dean of the UTHealth School of Buiomedical Informatics and his team are studying how emergency medicine doctors can best deal with a high workload, constant interruptions, and the need to multitask. The researchers are particularly interested in how doctors switch back and forth between tasks and how this affects their decision-making.

The study will be conducted at Memorial Hermann Texas Medical Center which has the nation’s busiest trauma center. In 2009, the U.S. emergency departments had 136 million visits and about a third of the visits were for injuries.

Several possible improvements that could be instituted in emergency departments include using a dashboard to display vital information and developing software programs for tracking patient data on tablets.

Testing for communication systems will be done in a virtual world called Second Life. There, the researchers will be able to simulate the activities of a busy emergency department and be able to introduce their communication prototypes.

Army's Work with Language Barriers

The Army realizes that language barriers can make communicating a challenge and can hinder the delivery of effective medical care. Without the assistance of a human translator, a medic may not be able to accurately capture enough information to fully address a patient’s needs.

Researchers from RDECOM’s “Communications Electronics Research Development and Engineering Center” or CERDEC have spent the past year developing strategies and methods to use to improve machine foreign language translation software in support of military medical translation needs.

After hearing reports about translation challenges in Haiti’s 2010 earthquake, TATRC recognized that the need for translation was pressing for the medical community and that the Army could assist with the engineering research and development to help improve medical capabilities.

According to Ray Schulze, Chief, Information Management Branch for CERDEC’s Command, Power and Integration (CP&I) Directorate, the Army is specializing in language translation in the disconnected environment and is working on various mobile platforms.

Schulze reports that using the combination of automatic speech recognition which takes the spoken word and converts it into text along with foreign language translation technologies does already exist, but the accuracy of those technologies is mediocre at best when used within the medical domain.

In some locations, soldiers currently have foreign language translation technologies like the new Phraselator, initially developed by DARPA developed in partnership with CERDEC in 2001. These systems were developed for particular soldier scenarios using one-way translation and generic phrases that require the user to stick to a script. Commercial translation applications also exist, but they are made for tourists in foreign countries.

The “Medical Application of Speech Translation” or MAST is a collaborative research project between CERDEC, TATRC, and the Army’s Southern Command called SOUTHCOM. TATRC is the sponsor and program manager for MAST while CERDEC provides the engineering support and SOUTHCOM facilitates access to the operational environment and end user base.

“Medics are seeking a small portable solution to basically house translation software that runs on a mobile device to be used without an internet connection,” said Cynthia Barrigan, MAST Program Manager and Portfolio Manager for global health engagement at TATRC.

She said, “In addition, we know that while users are interested in using translation technology, they are concerned with how to integrate it into their clinical routine in the field and how a patient will react to it. They are also aware that the translation needs to be very accurate to be useful.”

The MAST project team went into the field armed with a variety of mobile devices loaded with a commercial translation software application called “Jibbigo”. The MAST team gathered useful operational data and demonstrated the technology to users.

Daniel Yaeger, a CACI contractor supporting CERDEC CP&I is a subject matter expert in the area of machine language translation. He has traveled to Honduras three times in the past six months performing technology demonstrations and collecting simulated data for the MAST project. Each trip to Honduras used different hardware, microphones, and devices to gain feedback from doctors.

 He reports that the more data you give the program, the better it becomes and that translation software becomes more accurate in much the same way a small child learns. He said,” A child learns by listening to conversations, and then they absorb the information. This is similar to statistical machine language translation because essentially, you tell the program what sound means for a specific text. When you do this enough times, the algorithms behind the machines translation software actually learns these new phrases.

CERDEC CP&I engineers followed SOUTHCOM medics on several medical readiness training exercises to observe how medics interact and communicate with patients. This included observing the process of registration, triage, and observing the types of conversations between doctors and patients. By understanding how medics interact with patients, engineers can determine the specific requirements that are needed to develop an effective machine translation system.

Maryland Addresses Health Disparities

In October, the State held their annual Maryland Health Disparities Conference sponsored by the Maryland Department of Health and Mental Hygiene (DHMH) Office of Minority Health and Health Disparities (MHHD) and co-sponsored by the University of Maryland’s School of Public Health and the Maryland Center for Health Equity.

“Addressing the persistent gaps and disparities that persist in our communities is one of the greatest challenges of our time and the Maryland Health Disparities Conference is an important part of that effort,” said Lt. Governor Brown. “I was happy to lead the effort to pass legislation titled Maryland Health Improvement and Disparities Reduction Act of 2012 which established the Health Enterprise Zone (HEZ) Program.” 

HEZs are contiguous geographic areas that demonstrate measurable health disparities, are economically disadvantaged, and exhibit poor health outcomes. The purpose for the HEZ program is to reduce health disparities among racial and ethnic minority populations in geographic areas, improve healthcare access and health outcomes in underserved communities, reduce healthcare costs, plus reduce hospital admissions and re-admissions.

The HEZ program a four year pilot will provide $4 million per year to address health disparities by enabling underserved and isolated communities to draw on a range of incentives, benefits, and grant funding.

Once the communities are designated as HEZs, they will have access to state income tax credits, hiring tax credits, loan repayment assistance, priority entrance into the state’s Patient-Centered Medical Home Program, priority for available state EHR grant funding, and additional grant funding from the Maryland Community Health Resources Commission (CHRC).

In October, as a result of the passage of the Act, Lt. Governor Brown announced that the CHRC issued a Call for Proposals for Health Enterprise Zones (HEZ) due November 13, 2012 to be jointly administered by the CHRC and DHMH.

At this time, through the proposal process, non-profit community-based organizations and local health departments could apply for HEZ designation status. The DHMH Secretary will make the final HEZ designations by the end of 2012 and the State is expected to award two to four zones as part of the pilot program.

VA Medical Center News

Cardiac surgeries performed at the Washington D.C VA Medical Center (DCVAMC) are now more accurate due to the latest intra-operative tool, the Medistim VeriQC system. DCVAMC is one of only twelve VA medical centers employing this latest technological advance which combines ultrasound and Doppler velocity measurements.

VeriQC uses two probes in the operating room. One probe is for epicardial imaging and the other probe is for transit time blood flow measurement. According to DCVAMC’s Chief of Cardiac Surgery, Dr. Gregory Trachiotis, “The VeriQC system is an essential quality control tool used before and during coronary artery bypass procedures. This helps plan our revascularization strategy to ensure a more precise and complete revascularization”.

The tool also allows the surgeon to view anastomosis or search for intramycardial vessels which makes surgery quicker and thereby reducing the amount of time the patient is under an anesthetic.

The second probe measures the volume of blood flow and resistance to flow in real-time. This enables the surgeon to evaluate the success of the revascularization while the patient is still on the operating table.

The Providence VA Medical Center’s new “Center of Excellence for Neurorestoration and Neurotechnology” (CfNN) is a major asset for brain science research funded with $900,000 per year for five years from the Department of Veterans Affairs Rehabilitation Research and Development Service.

CfNN is a collaboration combining the talents of the Providence VA Medical Center, Brown Institute for Brain Science at Brown University, Butler Hospital, Lifespan, and Massachusetts General Hospital to advance and translate new therapies and technologies to restore function in disorders of major interest to veterans. These disorders include spinal cord injuries, limb loss, strokes, PTSD, pain, Parkinson’s disease, multiple sclerosis, and depression.

The Center combines a Clinical Research Support Core with a Neuroimaging Core to support research and development in four focus areas:

• Development of brain computer interfaces for people with paralysis or limb loss
• Prosthetic limb evaluation and translation to use
• Robotic and imaging-guided neurorehabilitation technology and testing
• Neuromodulation technology for neurorehabilitation in pain, depression, and PTSD

ODU Practicing Teamwork

Modeling and simulation researchers at Old Dominion University (ODU) in Norfolk Virginia have teamed up with surgeons from Children’s Hospital of the King’s Daughters (CHKD) also located in Norfolk, to treat common chest deformities in children.

Pectus excavatum, Latin for “hollowed chest”, causes several ribs and the sternum to grow abnormally. This produces a caved-in or sunken appearance of the chest which can be present at birth or not develop until puberty.

In the 1990’s CHKD surgeon Donald Nuss developed a minimally invasive technique to correct the problem. In the Nuss procedure, the surgeon threads a curved metal bar under the sternum to push it out into a normal position. The bar is anchored to the ribs and remains in place for two years so the chest wall can harden in its new position.

To advance the treatment, the Eastern Virginia Medical School is continuing to refine the procedure. The researchers developed and are collaborating with modeling and simulation researchers from ODU to develop a new device referred to as the Pectus Bar Extractor. The goal is to improve the procedure and to develop hands-on simulation to train physicians to perform it safely.

The Pectus Bar Extractor was tested on a patient March 2012 with promising results. Now the research team hopes to make several more extraction tools for the clinical trial which could lead to commercialization of the device.

Another ODU project is in motion to address team work to more efficiently provide healthcare especially in rural areas. HRSA awarded a $1 million grant to ODU to more effectively help provide healthcare to underserved and rural populations. According to Carolyn Rutledge, Director of ODU’s DNP’s Advanced Practice Program, currently patients are often seen by a single provider, often a physician but not by a team of professionals.

To help stress teamwork in the medical profession, the HRSA grant will enable graduate students in ODU’s nurse practitioner, dental hygiene, physical therapy, and clinical counseling programs to be co-taught by faculty members from all four disciplines starting with the spring 2013 semester.

The three required courses will focus on health promotion, geriatrics, and leadership team-based care. The goal is for the students to understand what each discipline has to offer and then learn how to really work together as a team.

“Students will learn from each other’s expertise to improve patient outcomes,” Rutledge explained. “Since healthcare is a concern in caring for those in remote, rural regions, students will learn to function as interprofessional teams at a distance, using healthcare technology such as social media, telehealth, and EHRs. This will result in an innovative virtual patient-centered home.”

Partners in mHealth

The mHealth Alliance, the Thomson Reuters Foundation, Baker & McKenzie, and Merck are partnering on a new project to increase the understanding of privacy and security policies related to the use of mobile technologies in healthcare.

According to a 2011 World Health Organization report, governments cite issues related to data privacy and security and the protection of individual health information as two of the top barriers to the expansion of mHealth. Protecting personal health information that is collected and transmitted over mobile devices is essential to bringing mHealth to scale.

The project will develop case studies of seven geographically diverse countries where mHealth programs are underway. These countries include Bangladesh, Chile, India, Nigeria, Peru, Tanzania, and Uganda. Working with law firms in those countries, the partners will research and analyze the status of policies, laws, and standards that address mHealth-related privacy and security issues.

The goal is to better understand the current policy landscape and identify gaps that must be addressed to protect health data transmitted over mobile devices. Next year, the partners will release the policy landscape analysis and outline best practices and recommended steps to close policy gaps in the ethical and secure use of mHealth data.

The project was facilitated by TrustLaw Connect, a Thomson Reuters Foundation service which allows NGOs and social enterprises to access free legal assistance. TrustLaw Connect brokered the partnership between the mHealth alliance and the team of global and local law firms led by Baker & McKenzie and the legal team at Merck.

Tracking Genetic Tests

NIH has developed a new online tool called the Genetic Testing Registry (GTR) to make it easier to navigate the rapidly changing landscape of genetic tests. The GTR database was developed by the National Library of Medicine’s National Center for Biotechnology Information (NCBI).

According to NIH Director Francis S. Collins, M.D., PhD, “The registry will help not only healthcare professionals looking for answers to their patients’ diseases but also researchers seeking to identify gaps in scientific knowledge.”

Genetic tests currently exist for about 2.500 diseases and the field continues to grow at an astonishing rate. To keep pace, GTR will be updated frequently, using data voluntarily submitted by genetic test providers. This information will include the purpose of each test, limitations, the name and location of the test provider, whether it is a clinical or research test, what methods were used, and what is being measured.

In addition to basic facts, GTR will offer detailed information on analytic validity which assesses how accurately and reliably the test measures the genetic target, clinical validity, assesses how consistently and accurately the test detects or predicts the outcome of interest, information related to the test’s clinical utility, and how likely the test is to improve patient outcomes.

“Our new registry features a versatile search interface that allows users to search by test, conditions, genes, genetic mutations, and laboratories,” said Wendy Rubinstein, M.D. PhD, and Director of GGTR. “What’s more, we designed this tool to serve as a portal to other medical genetics information, with context-specific links to practice guidelines and to provide a variety of genetic, scientific and literature resources available through NLM.

GTR is available at www.ncbi.nlm.nih.gov/gtr.

Funding for Hepatitis Research

Despite advances in the treatment of chronic viral hepatitis B and C, the persistence and the emergence of other hepatitis viruses continues to remain a public health challenge in the U.S. Currently, it is estimated that 3.5 to 5.3 million people in the U.S are afflicted by viral hepatitis. Even with advances in medical care, 12,000 to 15,000 Americans succumb to the complications of acute or chronic viral hepatitis each year.

In 2010, the Institute of Medicine (IOM) released a report highlighting viral hepatitis as a national health concern and outlined the barriers hindering healthcare delivery for viral hepatitis patients. As a result of the IOM report, HHS generated a “Viral Hepatitis Action Plan” on how to respond to the public health implications of acute and chronic viral hepatitis.

This year NIH issued Funding Opportunity Announcement (PA-12-091) titled “New Technologies for Viral Hepatitis STTR”. The funding is to encourage Small Business Innovation Research (STTR) and have small businesses respond with research ideas to the HHS “Viral Hepatitis Action Plan”.

STTR grant applicants for the NIH Funding Opportunity Announcement are encouraged to submit ideas on developing resources, research tools, instrumentations, biomarkers, devices, drugs, or submit new and innovative approaches to diagnosing, monitoring, managing, treating, and preventing viral hepatitis and viral hepatitis associated liver disease.

The STTR program has been in place for a number of years. Each year, federal agencies with extramural R&D budgets that exceed $1 billion are required to reserve 0.3 percent of their extramural research budget for STTR awards to small businesses. In doing this, the agencies designate R&D topics in their solicitations and then accept proposals.

Five agencies including DOD, DOE, HHS, NASA, and NSF are involved in the STTR program to expand funding opportunities in R&D and to use public and private sector partnerships to include joint venture opportunities with small businesses.

The total funding may not exceed $150,000 for Phase I awards and $1,000,000 for Phase II awards. The earliest submission for proposals was March 5, 2012 with final proposals due January 2015.  Go to http://grants.nih.gov/grants/guide/pa-files/PA-12-091.html for more information. 

Hospital Ships Convert to TMIP-J

 The U.S Navy ship Comfort and her sister ship Mercy are the Navy’s two current hospital ships operated by the Military Sealift Command. For years, the hospital ships used the Composite Health Care System (CHCS) to support patient care documentation. The system allows clinicians to electronically perform patient appointment and scheduling, order lab tests, authorize radiology procedures, and prescribe medications. However, the CHCS does not fully support the military health system’s advances in sharing clinical information across all levels of care.

One of the solutions was to convert to the Theater Medical Information Program-Joint or

TMIP-J, a family of systems designed to aid deployed medical personnel in all levels of care in theater. The system can provide complete clinical care documentation, track medical supplies and equipment, and provide for health surveillance. TMIP-J system is able to adapt and integrate a number of commercial and government off-the-shelf medical systems to support military operations.

In 2011, the TMIP-J and the Composite Health Care System Cache (TC2) team traveled to the Mercy in San Diego to assist the TMIP Maritime Program Office convert the hospital ship to a Theater healthcare documentation platform.

After the platform conversion in San Diego, the team traveled to Baltimore to complete the conversion on the Comfort. The TC2 product team installed and configured the TC2 application while the TMIP Maritime team completed the installation and configuration of AHLTA Theater.

The project involved installing TC2 from the ground up and manually rebuilding all wards, hospital locations, laboratory tests, radiology exams, medication formularies, and interfaces. With the identical layout and capabilities of both ships, the team used the Mercy image to make subtle changes to the configuration to support the minor differences on the Comfort.

As a result of the efforts of the TMIP Maritime teams, most of the patient care documentation performed on these floating military treatment facilities now flows to the Theater Medical Data Store, AHLTA, and to the Clinical Data Repository, then on to the VA.

Since the conversion to the TMIP-J, the Mercy embarked on a Pacific Partnership mission, a four month humanitarian operation to Cambodia, Indonesia, the Philippines, and Vietnam. The Comfort’s first mission with the TMIP-J has supported operation “Continuing Promise” by visiting a variety of countries in the Caribbean Basin, Central America, and the northern portion of South America.

Source: October 2012 Defense Health Information Management System newsletter “The Beat”.