Wednesday, January 30, 2013

Agencies Seek Research Ideas

NIH, CDC, FDA, and ACF have just issued their SBIR/STTR solicitation seeking research ideas. Many of the topics include a wide variety of ideas for new types of technology such as sensors, software, point-of-care devices, drug delivery systems, electronic records, web-based tools, medical devices, and other new ideas.

Several agencies specifically mentioned technologies for telemedicine and telehealth:

  • NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB) is interested in small research companies developing software and hardware for telehealth. Research studies should have broad applications as well as early stage development of telehealth technologies

  • NIBIB is interested in research that would address usability and implementation issues in remote settings plus methods to develop technology for standardizing and incorporating state-of-the-art security protocols for verifying user identities and preserving patient confidentiality across remote access

  • The National Institute of Aging within NIH is looking to see innovative technologies involving hand-held devices, new ways to use the internet, telemedicine, social networking, and other communications technologies to help older adults live independently and safely in their homes

  • The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) would like research companies to develop telemedicine approaches that could be incorporated as components and/or develop an artificial pancreas for better diabetes self-management

  • The National Institute on Minority Health and Health Disparities (NIMHD) is seeking innovations in mobile health, telehealth/telemedicine technologies for communication, diagnosis, monitoring, evaluation, medical management, training to be used in underserved community settings and in rural and remote locations

  • The National Institute of Nursing Research wants to use telehealth technologies to improve patient outcomes by increasing quality, type, and speed of health information sharing. Telehealth is needed to help to assess traumatic injury severity at remote sites and transmit this information to acute care settings.
 Go to to view the solicitation for the SBIR Funding Announcement (PA 13-088) and for the STTR funding Announcement (PA-13-089). Submission dates are April 5, August 5, and December 5, 2013. The main NIH SBIR/STTR site is at

State Initiating Care Coordination

In Illinois, care coordination will be provided by traditional insurance-based HMOs, Managed Care Community Networks, (MCCN), and Care Coordination Entities (CCE). CCEs are provider-organized networks providing care coordination for risk and performance-based fees but with medical and other services paid on a fee-for-service basis.

An initial group of six CCEs and MCCNs recently were awarded contracts under the state Department of Healthcare and Family Services (HFS) Care Coordination Innovations project. This program is expected to grow in order to provide care coordination for children with complex health needs.

Illinois Medicaid’s two year draft plan “Care Coordination Roll-Out Plan from January 2013 to January 2015” centers on how to meet the state law that requires at least 50 percent of their Medicaid clients to move into care coordination by January 1, 2015. Under this plan, the goal is to have about two million out of three million clients or 66 percent in care coordination by the deadline.

The major roll-out plan will focus on Seniors and Persons with Disabilities (SPD) who comprise 16 percent of the Medicaid population but incur 55 percent of Medicaid costs. Since some of the SPD population includes dual-eligibles, the state expects the federal government to partner with Illinois Medicaid to provide better coordination of services under the unique demonstration program called the “Medicare-Medicaid Alignment Initiative” (MMAI).

The state estimates that approximately 136,000 seniors and adults with disabilities will be eligible for care under the MMAI program. The MMAI demonstration, a joint effort with CMS is a key component of the state’s transition to expanded coordinated care for Medicaid clients by 2015.  In November, HFS named eight health plans to partner with the state as the majority of people covered by Medicaid will be moved to the system of coordinated care.

DOD Seeks Research Projects

On January 24th, DOD issued grant notice “DOD FY 13 Forward Surgical and En Route Care” (W81XWH-13-CCCJPC6-FSERC) with estimated funding of $17,000,000. DOD seeks research technologies that will improve outcomes for their Combat Casualty Care Research Program. TATRC is administering the application process for this Cooperative Agreement Grant Notice and the U.S. Army Medical Research Acquisition Activity will be negotiating all resulting awards.

This FY 13 funding notice is interested in three priority areas related to en route care:

·        Impact of movement environment on patient physiology—Optimal casualty management to deal with possible organ system effects during patient movement, impact of the environment on the patient, hypoxic and hypobaric effects, determining oxygen requirements for patients at 8,000-17,000 feet in an unpressurized aircraft, initiating life saving interventions, and how to prevent hypothermia during pre-transport and transport of the  patient

·        Non-Invasive Methods for Patient Monitoring During Transport—Decision support tools for life-saving interventions, patient medical monitoring, recording and reporting in-transit and during patient stabilization and treatment, and simultaneous and remote monitoring of multiple patients

·        Development of en route care clinical practice guidelines and treatment protocols—To be based on all levels of care and transport methods

The Combat Care program is in need of targeted research on:

  • Novel methods to employ endovascular techniques without the need for radiographic imaging and the expanded use of intravascular ultrasound or other guiding devices to allow fluoroscopy-free rapid positioning of endovascular devices in emergency settings

  • Development of new endovascular techniques and devices such as sheaths, balloons, stents, and coils to control hemorrhage, that can serve as a life-sustaining resuscitation adjunct and/or definitively treat the causative vascular injury
Eligible applicants can be independent investigators at any academic level from government, academia, research institutions, industry, and private foundations.

The Pre-application submission deadline is February 25, 2012, full application March 18, 2013, and the full application submission deadline is May 6, 2013.

To view the funding opportunity, go to

Team to Provide Telemonitoring

Primary Partners, LLC, a physician owned and managed Accountable Care Organization has entered into a partnership agreement with AMC Health, a provider of telemonitoring solutions. The goal is to improve care coordination and outcomes for patients with chronic conditions.

Under the agreement, AMC Health will provide telemonitoring services to help care for Primary Partners’ patients with heart failure, diabetes, COPD, and other chronic illnesses. The telemonitoring services will enable Primary Partners to eliminate gaps in care that can occur after patients are discharged from a hospital.

AMC Health will provide a post-hospital discharge remote monitoring program and tailored disease-specific telmonitoring programs employing biometric devices such as blood pressure and glucose monitors and scales that automatically transmit readings for analysis so Primary Partner physicians. This enables the physicians to intervene before a patient requires a trip to the emergency department of to have to be hospitalized.

To help keep patients on track and encourage them to make healthy behavior changes, AMC Health will also offer customized coaching that aligns with patient’s specific circumstances, as well as installation, training, and repair for in-home monitoring devices.

According to Cara Jakob, M.D, one of Primary Partner’s founding physicians also serves as the Clinical Integration Director and Chairman of the Board, “We selected AMC Health because their telehealth solutions are patient-centered and scalable. This gives us the ability to tailor care management programs that best meet the individual needs of our high-risk patients who benefit from this extra level of monitoring.”  

Studying Mobility and Risk

Researchers at Oak Ridge National Laboratory’s Biomedical Science and Engineering Center are using online tools including social media to try to understand the impact of modern population migration patterns on cancer risk. 

In other words, what environmental factors change the risk of various cancers when people move from one geographic region to another? Researchers are examining case studies online, in print, and the resources of social media to develop a framework to help epidemiologists’ narrow future studies.

To do the scientific research, ORNL received grant funding for more than $1.6 million for a four year study to help them design cyber informatics tools that can search, read through, and translate large amounts of online information.

According to Georgia Tourassi, a researcher at ORNL’s lab, “There is a general movement to see how we can use social networks to not only help epidemiologists discover and monitor the spread of infectious diseases, but also answer a large range of epidemiologicasl questions specifically related to cancer.”

The researchers are going to compare information from studies and from expensive clinical trials to see if the information is similar to the information available when researchers mine online media. The goal is to demonstrate that social media can be used to answer epidemiological questions to set the stage for this type of research to be used in the cancer scientific community. 

Songhua X another researcher in the ORNL laboratory, and an expert on web intelligence and online contents mining will tailor the programs to filter out reliable stories on breast and lung cancer. The plan is to create a tool that will act like computer analysts and be capable of constantly collecting and processing information.

The next step is to link these stories with publicly available environmental data and then mine the information using artificial intelligence to search for associations where changes of migration has influenced environmental factors and cancer risk.

Collaboration with clinical specialists, cancer environmentalists, and biostatisticians from Brown University and the University of North Texas, will help ORNL researchers interpret the associations they discover.

VA Issues Presolicitation Notice

On January 25th, the Department of Veterans Affairs released a Presolicitation Notice “Data Analysis for Artificial Intelligence” (VA24513R0025) that was issued by the Washington D.C VA Medical Center (DCVAMC). The VISN 5 network’s goal is to apply sound business principles to effectively manage people, communications, technology, and governance.

To achieve these goals, the presolicitation request is based on a System Redesign project funded in 2010 with most of the tasks completed in 2011. The remaining tasks are the focus for this specific presolicitation.

The first specific task that the VA is going to address is data analysis. The VA needs to analyze data by relying on data mining techniques and artificial intelligence to analyze large massive databases, including test analysis.

The expected number of unique patients to be analyzed is 600,000 cases. Five years of CPRS data is available from each patient plus the data requires complex artificial intelligence techniques to do the analysis. Also, data from the VA’s informatics and computing infrastructure needs to be analyzed.  

One area to be analyzed involves examining the clinical visits that could have possibly been avoided through telemedicine or other remote contacts. The analysis needs to identify the factors that could lead to increasing access to appointments for primary or specialist care patients if telemedicine could be used.

Another area to be analyzed includes examining hospice consults notes, determining the severity of illnesses based on claims data and laboratory findings, examining the reasons for readmission to the hospital within 30 days, and examining the trajectory to death for severely ill patients.

After these tasks are completed, the second task is to use the data analysis to facilitate improvement by implementing what is called Lean projects within VADCMC. Different models of improvement have been tried, but the DCVAMC is going to focus on the Lean model. This would entail describing the extent of the problem using patient outcomes, training clinicians and managers on how to achieve improvement within the VA system, and designing four new care protocols to help to avoid wasted efforts that could in the end improve patient outcomes.

The response date for the presolicitation is February 9, 2013. For more information, go to or email Delterine Mickey at  

Sunday, January 27, 2013

HRSA Releases FOA

On January 18th, HRSA’s Office of Rural Health Policy released the Funding Opportunity Announcement (FOA) (HRSA-13-157) soliciting applications for the “Delta States Rural Development Network Grant Program”. The grant program is in place to fund organizations in the eight states that includes Alabama, Illinois, Kentucky, Tennessee, Arkansas, Louisiana, Mississippi, and Missouri.

The grant program helps to develop local healthcare needs and addresses prevalent health disparities in rural Delta communities. The Delta Program provides resources to help rural communities develop partnerships to jointly address health problems that can’t easily be solved by single entities working alone.

Applicants are required to propose multi-county/multi-parish projects that will help provide clinical health services for individuals with or at risk of developing chronic health diseases. Health indicators may include changes in knowledge, behavior, attitudes, as well as clinical biometrics and should demonstrate improvement in the rural Delta communities over time.

Due to the high disparities in the region, applicants need to propose a program based on one of the health focus areas such as diabetes, cardiovascular disease, or obesity. Chronic disease initiatives can be in programs focused on prevention, self-management, care coordination, or clinical care, but must be outcomes oriented.

Rural public or rural nonprofit private entities representing a network composed of three or more healthcare providers either nonprofit or for profit entities may apply. The applicant organization must be located in a non-metropolitan county or in a rural census tract of a metropolitan county and all services must be provided in a non-metropolitan county or rural census tract.  

Applications are due March 18, 2013. The program will provide funding during FY13 to 2015 with approximately $5,600,000 expected to be available annually to fund 12 grantees. Applicants may apply for a ceiling amount of $25,000 per county which will be eligible per year. The project period is three years.

 For more information, go to or email CAPT. Valerie A. Darden, Program Coordinator for the Office of Rural Health Policy at

CHeQ Announces New Funding

The California Health eQuality (CHeQ) program managed by the UC Davis Institute for Population Health Improvement (IPHI) has announced two new funding opportunities to support development of the HIE in the state. RFPs will be posted on the IPHI website no later than January 31, 2013 with completed proposals in both categories due on February 28, 2013.

The first award funding announcement the “Rural HIE Incentive Program” will establish an ongoing mechanism and structure so that rural medical communities may evaluate and contract with pre-selected HIE service providers. CHeQ will award contracts to a small number of HIE service providers to subsidize implementation of HIE services for qualifying rural healthcare providers.

Applicants must describe and price their services for directed exchange and/or query-based exchange with an option to address services enabling patient access to information. CHeQ has allocated up to $1,000,000 for this program and anticipates making awards to as many as five HIE service providers.

The second funding announcement the “Innovation in Data Analytics Awards” will provide funding to HIOs and provider organizations to implement data analytics tools to better manage shared patient populations served by three or more unaffiliated healthcare provider organizations or systems.

These electronic tools should support health maintenance, disease prevention services, chronic disease management and they should align with emerging care delivery and value-based payment models such as Patient-Centered Medical Homes and Accountable Care Organizations.

CHeQ is especially interested in projects that focus on high impact conditions and/or medically underserved populations but will consider all relevant proposals. CHeQ has allocated $300,000 for up to 2 Innovation in Data Analytics Awards.

CHeQ anticipates releasing RFPs for two additional award programs in February. One of these awards will support expansion of HIE for the urban safety-net in Los Angeles County, and the other award will address the exchange of data to support care coordination for medically complex populations such as Medicare Medicaid dual eligible beneficiaries.

An informational webinar will be held on Monday February 4, 2012 at 1:00 pm on the Rural HIE Incentive Program and at 2:00 pm for the Innovation in Data Analytics Awards . Dial in instructions will be posted on the CHeQ funding opportunities webpage.

NPRNA Re-Introduced in Congress

The National Pediatric Research Network Act (NPRNA) (H.R 225) originally introduced in the House in 2012 was re-introduced January 14th 2013 by Congresswoman Lois Capps from California along with Congresswoman Cathy McMorris Rodgers from the State of Washington. They were joined by a bipartisan group of four colleagues.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development and other national research institutes and centers would carry out activities involving pediatric research.

The NPRNA would focus primarily on pediatric rare diseases or conditions including genetic disorders such as spinal muscular atrophy and Duchenne muscular dystrophy or conditions related to birth defects such as Down syndrome and fragile X.

Funding may be awarded to help establish NPRNA and provide for grant awards, contracts, or other mechanisms to public or private nonprofit entities. The funding would be used for planning, establishing the program, for strengthening pediatric research, and for training researchers in pediatric research techniques.

The activities of NPRNA would need to be coordinated which means it would be necessary to coordinate the exchange of information. Each consortium receiving an award would need to assist CDC in establishing or expanding patient registries and other surveillance systems.

Reports compiled from the data would need to be submitted in report form to the Director of NIH and the Commissioner of Food and Drugs. Information would need to be submitted on the multisite clinical trials to be conducted and on the development for new approaches to therapies and methods used to diagnose one or more pediatric rare diseases or conditions.

For more information, go to

Older Adults Use mHealth

In order for older adults to use mHealth, the Center for Technology and Aging (CTA) works with healthcare providers, aging service organizations, payers, foundations, and technology companies to accelerate the deployment of proven technologies. CTA works closely with the Administration on Aging, CMS, ONC, state governments, the SCAN Foundation, California HealthCare Foundation, and the Gordon and Betty Moore Foundation.

According to David Lindeman PhD, Director for the Center for Technology and Aging (CTA), the use of mobile health solutions is providing effective ways to treat the older adult population and enables them to remain at home.

Today, CTA formed partnerships with funders to help design programs to meet strategic goals centered on technology, aging, and chronic disease management. As previously announced, CTA’s mHealth Diffusion Grants Program awards went to several awardees such as CalOptima, Family Services Agency (San Francisco), Front Porch Center for Technology Innovation and Wellbeing, HealthInsight a collaborative effort with the Utah Beacon Community, and Sharp HealthCare Foundation.

Grantees accomplishments:

  • CalOptima initiated their Heart Health Pilot Program with five one year grants using RPM, MedOP devices, and cell phones in home settings in Orange County California. The goal was to prevent or delay transitioning Medicare patients with congestive heart failure to higher levels of care

  • Family Services Agency of San Francisco, a regional social service agency is using a tablet-based touch screen assessment tool, a care planning tool, and a cloud-based EHR to help frail and isolated low-income seniors with behavioral health or substance abuse issues. The technology called CIRCE-ADEPT enables clinicians to quickly screen and assess clients and use results to help treatment planning

  • The Front Porch Center for Technology Innovation and Wellbeing program uses mobile technology to help seniors in a Continuing Care Retirement Center in Los Angeles. The Center is addressing medication adherence among active independent older adults by using cell phone texting reminders via a two way SMS-based medication reminder service.

  • The Utah Beacon Community’s “IC3 Diabetes Mobile Health Pilot” uses mobile health tools such as Voxiva’s Care4Life technology which is a personalized interactive mobile health services designed to help patients with diabetes. Two way interactive text messaging assists 310 patients enrolled in the Care4Life text messaging study across 14 provider sites. Care4Life increases blood glucose monitoring by sending glucose reminders, provides immediate feedback, tracks all glucose recordings on a web portal, sends education messages, and provides tips. Several patients have presented blood glucose reading in normal ranges after years of chronic diabetes complications.

  • The Sharp HealthCare Foundation has a project helping COPD patients to better manage chronic care effectively using mHealth. The technology is helping the underserved  Medicare Fee-for-Service patients at Sharp Grossmont Hospital with primary or secondary diagnosis of COPD. The “Cardocom Commander Flex” a web-enabled data portal and a personal health coach enables Sharp to care for at least 120-180 patients with COPD by monitoring daily oxygen saturation along with symptoms. Information is automatically sent over a cellular network to a data portal for analysis by the chronic care RN project coordinator.
In general, the CTA mHealth Demonstration grants are showing that technology is ten percent of the issue. Ninety percent of technology deployment and adoption requires staff engagement and buy-in, developing the work flow process, developing effective technology deployment strategy, providing for organizational leadership, and emphasizing change management in the organization.

For more information, go to  

New Monitoring System Developed

Electrical engineers at Oregon State University have developed new technology to monitor medical vital signs with sophisticated sensors so small and cheap they can fit into a bandage and be manufactured in high volumes. The new system-on-a-chip cuts the size, weight, power consumption, by ten times. What enables the small size is that the system doesn’t use a battery. It is able to harvest sparse radio-frequency energy from a nearby device such as a cell phone. 

Some of the existing technologies that would compete with this system, such as pedometers currently in use that measure physical activity, cost $100 or more. The new system by comparison is about the size and thickness of a postage stamp and can easily be taped over the heart or at other body locations to measure vital signs.

A patent is being processed for the monitoring system and the system is now ready for clinical trials, researchers say. When commercialized it could be used as a disposable electronic sensor, with many potential applications due to its powerful performance, small size, and low cost.

The system can be used to monitor hearts since the system can gather data on some components of an EKG, such as pulse rate and atrial fibrillation. The system has the ability to measure EEG brain signals so it could be used to provide nursing care for patients with dementia, be used to record physical activity to help improve weight loss, used to measure perspiration and temperature to provide data on infections, and to provide data on the onset of diseases.

The research has been supported by the National Science Foundation and the Catalyst Foundation.

News from Medtronic

Medtronic Inc. has enrolled the first patients in MIRACLE EF, a global clinical trial to evaluate the effectiveness of Cardiac Resynchronization Therapy-Pacemakers (CRT-P). The technology can be used to delay the progression of heart failure in symptomatic patients with mild reduced heart pumping function.

This large study will be the first to evaluate CRT-P in a widely underserved patient group. The group consists of patients that have a slightly reduced Left Ventricular Ejection Fraction (LVEF) in the range of 36 to 50 percent. This means that the hearts work somewhat more efficiently than heart failure patients who are currently indicated for implanted device therapy because of their lower LVEF.

Approximately 275 centers throughout the world in regions including the U.S. Canada, Europe, Japan plus developing markets will enroll up to 2.300 patients who will receive a Medtronic Consulta®  CRT-P in this prospective, double-blind randomized controlled trial. Patients will be followed for at least two years or until the close of the study. Medtronic anticipates the trial will take four to five years to complete. The CRT-P devices used in Miracle EF are not approved by the FDA for the patient population being studied.

In addition, Yale University is working in partnership with Medtronic University through a five year cooperative agreement established by the FDA to develop enhanced methods to evaluate the safety of medical devices.

The partners will develop a general framework for key methodologies, best practices, and strategies that are essential for the development of an effective U.S. medical device surveillance registry network.

“There is a great need to develop methods and initiatives to ensure that the devices that are approved are truly safe and effective when they are adopted into practice,” said Harlan Krumholz, M.D., Professor of Medicine and Director of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation. “We need systems that provide early warnings if there are problems and provide the information needed to ensure that these devices are providing the benefits that we expect,” Krumholz added.

For more information, go to

Tuesday, January 22, 2013

NTIA Administrator Delivers Remarks

National Telecommunications and Information Administration (NTIA) Administrator Lawrence E. Strickling highlighted the success of NTIA’s Broadband Technology Opportunities Program (BTOP) over the past three years at a panel discussion held at Brookings Institution in Washington D.C. on January 16th.

According to Strickling, NTIA with 4.7 billion in funding has deployed or upgraded 78,000 miles of broadband infrastructure. So far, 11,200 community anchor institutions including schools, hospitals, and libraries have been connected to broadband networks. NTIA has also installed more than 38,600 computer workstations in 2,600 public computer centers in 1,500 communities and generated more than 510,000 new broadband subscribers.

Strickling discussed how grantees are using Recovery Act funding to connect more than 3,000 healthcare facilities across the country. Seventy-five percent of these facilities are getting at least 10 megabits per second of bandwidth, which enables high definition video consultations and real-time image transfers. Over 40 percent of the facilities will be connected to more than 100 megabits per second of bandwidth to support the remote monitoring of patients.

As an example of how broadband really helps communities, one of the panelists Curtis Lowery, Jr., M.D., Professor and Chairman of the Department of Obstetrics and Gynecology, and Director for the Center for Distance Health at the University of Arkansas for Medical Sciences, recounted how technology is really helping at UAMS to bring medical care to rural areas.

He told the story of how a 43 year old mother of five in Arkansas suffered a massive stroke and was rushed to Northwest Medical Center in Bentonville Arkansas. Dr. Lowery said that the local hospital did not have the resources to adequately evaluate Smith’s medical condition to determine if the stroke had been caused by a blood clot. At this point, the woman was more than three hours away from a major regional medical center in Little Rock but the doctors in Bentonville felt that was too long to wait for an answer and start the treatment.

So the doctors at the hospital in Bentonville consulted with an on-call neurologist affiliated with UAMS over broadband. The neurologist was able to talk to and examine the woman over an interactive video conferencing system and quickly determined that she would benefit from a blood thinning drug. After the drug was administered, Smith was taken to the UAMS hospital by ambulance and soon after, she was able to speak.   

To make telemedicine possible, UAMS is using their $102 million Recovery Act award to build a statewide fiber-optic network to integrate, upgrade, and to extend two existing networks. The new network is going to reach all 75 counties in the state and connect or upgrade 81 hospitals, 12 healthcare training centers, and 113 local health facilities.

As a very active participant in the field, Dr. Lowery helped establish a Medicaid-funded cost-effective solution to assist high risk pregnancies in the state referred to as the ANGELS program. This program gives women access to genetics counselors and maternal and fetal medicine specialists who monitor them and conduct live fetal ultrasounds from a distance. The university is using grant funds to expand ANGELS to 36 sites around the state.

One participating facility is the Mena Regional Health System in Arkansas, in a town of 6,000 located 125 miles from Little Rock. Dr. John Mesko and the other obstetrician in town deliver roughly 450 babies a year and Mesko estimates that at least a quarter of those mothers have had at least one telemedicine ultrasound during their pregnancy.

In addition to ANGELS, Dr. Lowery founded the UAMS Center for Distance Health, a technology-based partnership within the College of Medicine and Regional Programs. The Center offers telemedicine, continuing medical and health education, public health education, and evaluation research.

Other participants in the panel discussion included the Moderator Darrell West Vice President and Director, Governance Studies at Brookings, Bruce Abraham Member of the Board of Directors at North Georgia Network, Susan Corbett, CEO, Axiom Technologies, and Mark Malaspina, President CFY.

For more information, go to   

Cloud Computing/Big Data Discussed

The “NIST Cloud and Big Data Workshop” held January 15-17, 2013 at NIST headquarters in Gaithersburg Maryland brought together leaders and innovators from industry, academia, and government. The session opened with keynoter Patrick Gallagher discussing issues involving both Cloud Computing and Big Data. Gallagher is Under Secretary of Commerce for Standards and Technology and also serves as the Director for the National Institute of Standards and Technology (NIST).

Cloud Computing is defined as collecting and delivering data via remote servers accessed through the internet and Big Data is defined as working with a collection of data sets so large and complex that it is difficult to process the data using present methods. As Gallagher explained, it is essential to integrate both not as separate entities but discuss where Cloud Computing intersects with Big Data so that the solutions can advance both in the right direction to meet future requirements. According to Gallagher, both Cloud Computing and Big Data can open the window of opportunity but only if we work together and share solutions.

Since Cloud Computing and Big Data are evolving programs, structured dialogue needs to take place on privacy issues, how to successfully converge cloud computing and big data, examine how the U.S. government Cloud Computing Roadmap is progressing, look at the standards needed internationally, realize the importance of use case discussions, and listen to ideas on how to develop deployment models.

In other discussions on Cloud Computing, the Defense Department is actively examining privacy and security issues to see how DOD, other government agencies, and private industry can effectively shift toward cloud computing. Robert Carey, Department of Defense Principal Deputy Chief for CIO reported at another meeting held on January 14th, that the cloud is secure but only for certain types of data. The biggest problem however is how to accomplish cloud computing goals at the same time that DOD is facing budget constraints.

At this time, Carey explained, there are a number of DOD pilot programs going on to evaluate all of the issues involved in cloud computing but these issues are not always easy to address. “The idea of concentrating on securing data rather than on an entire network is a big shift in thinking for an agency like DOD, according to Cary.”

At a the House Veterans Committee hearing held on Capitol Hill on January 17th, security issues were brought up by Joel C. Willemssen, Managing Director for Information Technology for the Government Accountability Office.

He reported on the risks involved with Cloud Computing. “The risks include dependence on security practices and concerns related to sharing computing resources. However, this risk may vary based on the cloud deployment model used. Private clouds may have a lower threat exposure than public clouds, but it will require an examination of the specific security controls in place for the cloud’s implementation in order to evaluate this risk.” 

Report Submitted to the President

The President’s Council of Advisors on Science and Technology (PCAST) submitted the report “Designing a Digital Future: Federally Funded R&D in Networking and Information Technology” to the President on January 17, 2013.The report reviews the part that health IT plays in delivering mechanisms for health and well-being.

The report states that there is tremendous potential in the use of networking and information technology to develop new capabilities in medical devices, to increase data-driven development, discover new drug therapies, provide secure and robustly available health records, and to use technology to help in health maintenance. 

Several institutes within NIH have technology programs that go beyond EHRs. There are also health IT projects within the Big Data Initiative for both data collection and data analytics and within the National Robotics Initiative for both surgery and prosthesis.

According to the report, there has been progress in interagency collaboration on health IT. The Networking and Information Technology R&D (NITRD) program within the Executive Office of the President through their National Coordination Office (NCO) established the Health Information Technology R&D Senior Steering Group (SSG). The SSG developed the report, “Federal Health IT R&D Recommendations” which is currently under review by the White House Office of Science and Technology Policy (OSTP).

NCO also established the Health Information Technology Innovation and Development Environments (HITIDE) subgroup to coordinate agency activities in health IT. HITIDE is working on plans to develop federated national testbeds for interoperable health records and health systems.

CHeQ Program Awards Contract

The California Health eQuality (CHeQ) program managed by the UC Davis Institute for Population Health Improvement (IPHI) awarded a $417,011 contract to Scientific Technologies Corporation (STC), a population health informatics service company based in Tucson Arizona.  

STC in collaboration with CHeQ and the California Department of Public Health will develop an immunization “gateway” to allow healthcare providers throughout most of California to electronically submit patient immunization records for routing to state regional immunization registries to enable secure access by doctors, schools, daycare centers and parents. STC will provide planning, design, development, testing, and implementation services on the gateway project which is expected to launch April 2013.

The web-based immunization gateway will increase the capacity so that patient immunizations records can be received from a large number of healthcare providers and fulfill Stage 1 requirement for federal meaningful use of EHR technology.

The gateway will focus on processing data for seven of the state’s 10 regional immunization registries to include the San Francisco Bay Area, Central Coast, Central Valley, Greater Sacramento, Inland Empire, Los Angeles, Northern California, and Orange County. The remaining areas San Diego, San Joaquin, and Imperial counties use different systems and are not included.

“Developing an immunization gateway is a big step toward reaching our goal of making complete and accurate immunization information available to parents, patients, schools, day care centers and healthcare providers,” explained Kenneth W. Kizer, IPHI Director. “Having this information readily accessible will assist public health workers in their efforts to prevent many infectious diseases and should help parents and school officials stay on top of their children’s need for shots.”

Nevada's Exchange Strategy

According to the Kaiser Family Foundation, in 2011, there were 588,000 uninsured people in Nevada under the age of 65, representing 25 percent of that population. The state’s staff estimates that approximately two-thirds will be eligible for Medicaid with the remaining to become eligible for coverage through the Silver State Health Insurance Exchange.

Nevada’s Tribal community plays a vital role in the development of the Exchange. There are 19 federally recognized Tribes comprised of 28 separate Tribal bands, and community councils in Nevada. Representatives from the Indian Health Board of Nevada, the Washoe Tribal Health Center, and other tribal organizations have participated in the community stakeholder meetings. The State plans to further engage the Tribes in the planning process, mainly through the Indian Health Board of Nevada.

The state in developing Nevada’s Insurance Exchange is faced with challenges in terms of educating and enrolling the eligible population, expanding state services to absorb the Medicaid population, shifting costs, providing enough providers, and facing other market disruptions that may produce potential adverse effects.  

Today, plans for Nevada’s Exchange are well underway and the state is looking at how to address and really serve and connect with state residents. The system has been designed to enable residents to have direct input into the creation of the Exchange, to provide for a friendly business environment for Nevada’s small businesses, to maintain regulatory control over the state’s insurance market, and ensure that Nevada’s voice is heard not only at the state level but also federally.

An Exchange Board was appointed in 2012 and the Board has taken over actual implementation activities but continues communication, consensus building, and team work that the Nevada Department of Health and Human Services had started. The Board has met thirteen times the Advisory Committees has made substantial recommendations to the Board.

In 2011, the first official staff member to become part of the Exchange was a Grants and Project Analyst. In 2012, an Executive Officer was hired, and IT Officer positions were filled in July 2012. The Interim Finance Committee approved an IT Analyst position in 2012 that needs to be filled and recruitment is currently underway.

The state has compiled a compendium of background research reports on the commercial insurance market along with information on publicly-subsidized medical assistance programs, along with data on the uninsured. The reports are going to be updated on an on-going basis.

To provide more information, a website at  has been updated and contains the latest information on all news and documents related to health reform and the Exchange planning process. The public can access all of the Board and Advisory Committee meetings, agendas, and packets, as well as watch the meetings live via video conferences.

To move forward, the Exchange is planning a series of technical implementation meetings with Nevada’s insurance carriers to help familiarize carriers with the Exchange on-boarding process and to get input from the carriers to help the Exchange avoid potential pitfalls. An Exchange Summit may be scheduled for June 2013.

The technical infrastructure is moving forward and Deloitte has been hired as the vendor to design and build a HCR Eligibility Engine to be accessed by the Exchange for enrollment purposes. The eligibility engine will house all of the business rules to determine whether an individual is eligible for publicly subsidized programs or for subsidized or unsubsidized insurance through the Exchange.

The eligibility engine will be designed to communicate with the federal data hub which will gather information on income, citizenship, plus data from various federal agencies. In addition, the Exchange’s staff has been working with Xerox, Division of Welfare and Supportive Services (DWSS), and Deloitte to ensure that the operational implementation plan is synchronized with the IT implementation plan.

Some of the functions will be outsourced and others performed in-house or continued with current vendors. The Exchange has entered into contracts with Public Consulting Group, Milliman, CSG, and with Xerox State Healthcare LLC, and is negotiating several marketing and outreach contracts.

Source: Silver State Health Insurance Exchange: Fiscal and Operational Report—Released December 2012.  

Small Providers: Security Issues

The secure exchange of electronic health information is particularly challenging for small healthcare providers who may lack the security infrastructure or expertise that larger healthcare providers possess. Also, to secure an electronic health information exchange complete with desktops, laptops, and mobile devices and dealing with healthcare data exchange standards can be challenging.

The January 15th Federal Register (page 2953), announced that the National Cybersecurity Center of Excellence (NCCoE) is initiating the “Secure Exchange of Electronic Health Information Demonstration Project”. The goal for this specific demonstration project is to provide a security platform that is secure, usable, and affordable for small healthcare providers to exchange electronic health information.

NCCoE hosted by NIST with the State of Maryland Department of Economic Development, is a public-private collaboration located in Maryland to accelerate the widespread adoption of integrated cybersecurity tools and technologies. The Center brings experts together from industry, government, and academia under one roof to develop practical, interoperable cybersecurity approaches to address the real world needs of complex IT systems.

NIST is soliciting responses from vendors, academia, and integrators for the Demonstration project. All interested parties must complete a certification letter to be completed by March 1, 2013. NIST will then contact the interested parties if there are any questions regarding the certification letters or the project objectives or requirements. Selected participants will be required to enter into a consortium Cooperative Research and Development Agreement (CRADA) with NIST.

Additional details about the project will be made available at If interested, contact Karen Waltermire via email at or phone at (301) 975-4500.

Wednesday, January 16, 2013

VA Sponsoring Contest

The Veterans Administration is challenging software developers to create new systems that will schedule appointments in the VA’s health system when veterans need outpatient and ambulatory care from the Veterans Health Administration (VHA).  This challenge will award prizes for as much as $3 million to as many as three entrants.

The contest is driven by the VA’s decision to transition the VistA electronic health system into an openly architected product and to challenge developers to offer standards-based modular components that can be extended and modified much more easily than customized products.

“This contest marks a major change in direction by the VA to move away from software that is so customized that only the VA can use it and move toward open standards and commercial systems that will build on proven practices,” said Secretary of Veterans Affairs Eric K. Shinseki. “The competition will help veterans by encouraging ideas to provide more personalized care.”

The VA uses the Medical Scheduling Package (MSP) a component in the VistA EHR system to bring patients, clinicians, and other resources together so healthcare can be delivered. The VA currently relies on the MSP to perform non-scheduling functions including workload data capture and a broad range of workload and other management reports. The system reads data from more than 130 other VistA applications and has read and writes functionality with more than 30 additional applications.

The VA intends to replace the current MSP with a scheduling product that is a standards-based, modular, extensible, and scalable, and certified as compliant with the fully interoperable production version of VistA now held by the Open Source Electronic Health Record Agent (OSEHRA).

The replacement product will as a part of the overall VistA EHR system, deliver privacy, security, data integrity, patient accessibility, interoperability and other services required by federal law, regulations, and VA policy.

Proprietary commercial systems are eligible for prizes, but all entries in the contest will be required to have open connections or APIs. Entries with substantial open source content will be especially welcomed.

Contestants may register for the contest until 12:00 noon EDT on May 13, 2013. Registered contestants will need to send a letter to attest that the potential entrant and partner organizations are eligible to participate in the contest per the requirement of the October 16th, Federal Register Notice. Contest submissions will be accepted until 12:00 noon EDT on June 13, 2013.

For more information, go to

North Carolina's HIT Report

North Carolina and health IT partners have received grants across all categories of federal HIT funding totaling approximately $630 million and are expecting to exceed $1 billion in federal investments. The North Carolina Health Information Exchange (NC HIE) is currently in the implementation phase with core services deployed last April.

Blue Cross and Blue Shield of North Carolina (BCBSNC) in collaboration with NC HIE and Allscripts, launched the “North Carolina Program to Advance Technology for Health” (NC PATH) to equip 600 rural independent physicians with Allscripts EHR software and to connect healthcare providers across the state to the HIE.

BCBSNC is donating the cost to implement the EHRs. For in-network providers, BCBSNC will cover 85 percent of the software and maintenance costs plus HIE connectivity and membership fees for a period of 5 years. The provider is responsible for the remaining 15 percent.

The HIE is partnering with the North Carolina Community Care Network (NCCCN) to develop and deploy medication management services funded through a Supplemental Challenge Grant from ONC. Currently, there are 717 users on the medication management system.

The NCHIE launched the laboratory program with Solstas Lab Partners and Labcorp by signing a participation agreement and are now in contract discussions with Quest Diagnostics. A pilot program to make laboratory results from Solstas available through the NCHIE is currently being tested.

The state’s HIE has launched the NC Direct Program and now there are 792 Direct users. The NC HIE and DHHS are currently exploring opportunities on how to leverage NC Direct in the area of Public Health Services.

North Carolina’s Regional Extension Center (REC) has enrolled over 3,800 primary care providers which exceeded the previous goal of 3,465. The REC has coordinated their work with the Community Transformation Grant received by the state’s Division of Public Health. The NC AHEC will select 90 practices from the REC program to focus on improving outcomes in hypertension, high cholesterol, and tobacco use over the next year.

As of December 2012, the Beacon Community Grant has either fully or partially funded 30 projects in three country areas. For example, the Carolinas Medical Center-NorthEast (CCNC) has hired additional respiratory therapists to be embedded in primary care offices and in an emergency department to work on a COPD pilot. So far, 870 people have been screened for the project and 193 patients were identified as high risk for COPD.

In another project, the Rowan County Health Department through a Beacon Community Grant has upgraded their EMR system to a certified version and the department has nearly completed scanning and archiving their paper records.

The North Carolina Telehealth Network (NCTN) provides broadband services to health programs and sites across the state. To date, 61 NCTN-Public Health sites and 24 NCTN hospitals are fully operational. Another round of NCTN subscribers will be added in 2013.

The Microelectronic Center of North Carolina (MCNC) has completed upgrading the NCTN video conferencing services with interoperability established between standards-based IP videos, high definition, Cisco Telepresence, and desktop video conferencing.

The MCNC and the state’s Office for Information Technology Services are working closely with the NC HIE team to ensure that existing backbone networks and connections are provided to public health facilities, free clinics, hospitals, and that existing DHHS data repositories will be utilized to their maximum extent during the NC HIE implementation process.

Source: Quarterly Legislative Report—October through December 2012 prepared by the North Carolina Department of Health and Human Services, Office of Health Information Technology. Released January 1, 2013

New Developments in Dentistry

Last spring, NIH’s National Institute of Dental and Craniofacial Research (NIDCR) awarded a seven year grant for $66.8 million to consolidate the dental practice-based research network initiative into a unified nationally coordinated effort.

The effort renamed “National Dental Practice-Based Research Network” (NDPBRN) is now headquartered at the University of Alabama (UAB) at Birmingham in their School of Dentistry to serve as a hub to oversee six smaller regional research sites or nodes.

NDPBRN will conduct studies to better integrate dental practices into the larger healthcare system and at the same time, reach out to further dental education and document these changes that occur in everyday clinical practices. 

A dental practice-based research network is composed of practicing dentists and academic scientists. The network provides practitioners to participate in research studies that address day-to-day issues in oral healthcare. The studies are conducted in participating dental offices to help expand the profession’s evidence base to further refine care.

Since launching the practice-based initiative in 2005, NIDCR now supports three regional networks including the one at UAB. The initial seven year regional dental grants have been productive. The networks have enrolled 1,719 practitioners in 43 states and have organized 51 research studies that have generated 87 journal articles. Under the current NDPBRN grant, plans are to expand the number of participating practitioners to 5,000.

NDPBRN is also looking for practitioners to participate in various dental subspecialties such as endodontists, periodontists, orthodontists, oral surgeons, prosthodontists, oral pathologists, as well as pediatric and public health dentists. Community health centers, federal dental services as in the VA, DOD, and IHS are encouraged to participate.

Community Catalyst, a project underway to improve dental care has formed a panel of academic experts to develop a set of evidence-based national education standards for programs that educate dental therapists in the U.S.

Dental therapists serve as members of a dental team. They work under the supervision of a dentist in a collaborative way to extend the reach of the oral health care team. Dental therapists have been practicing in Alaska since 2006 and in Minnesota for one year with education programs in both states. Currently, dental therapists are working with no recognized national education standards or accreditation programs.

As more states consider expanding the dental workforce with alternative dental providers, the dental education community is calling for standards to guide the development of new programs. A new panel has been set up to build on curriculum guidelines for dental therapist education.

Dr. Dominick DePaola, Associate Dean at Nova Southeastern University College of Dental Medicine is serving as the Chairman of the “Dental Therapy Program Education Standards Advisory Panel” charged with developing the standards.

The recommendations established by the panel will build upon research and best practices derived from existing dental therapist education and practice programs in the U.S. and other countries. The panel will incorporate the recent work of the American Association of Public Health Dentistry, which developed and recommended a model curriculum that could be used by institutions considering establishing dental therapist education programs.

With the growing numbers of people seeking treatment for dental problems, half a dozen states have submitted legislation seeking to establish dental therapists. Other states, coalitions, and tribes are pursing pilot projects studying the feasibility of adding dental therapists to the dental team, and multiple other states are seeking and sharing information on the option.

The Advisory panel met in December and plans to complete the recommendations in 2013. Community Catalyst with the assistance of the LPaC Alliance, a law, policy, and consulting firm based in Minnesota with experience in establishing dental therapists in their state and the W.K Kellogg Foundation are funding the project.

Patient Record Still Strong

The Rochester Epidemiology Project funded by NIH’s National Institute on Aging is still going strong after almost 50 years. The project’s comprehensive medical records pool makes Olmsted County, Minnesota one of the few places in the world where scientists can study virtually an entire geographic population to identify trends in disease, evaluate treatments, and find factors that put people at risk for illnesses. The real value to researchers is to figure out the frequency of certain conditions such as heart disease and the true success of treatments.

The project began at Mayo Clinic long before computers existed. Mayo archived patient medical records believing they would someday be of value to researchers. In 1966, Mayo obtained NIH funding to link medical records from healthcare providers across the country including the Olmsted Medical Center and the Rochester Family Medicine Clinic. At that point, the Rochester Epidemiology Project was born and eventually the records were computerized.

As it nears the half century mark, the project is still growing. Healthcare providers in seven Southeastern Minnesota counties are adding patients’ records which have doubled the number of area residents included in the system. So far, the project has supported more than 2,000 studies with fewer than five percent of Olmsted County’s residents choosing to opt out.

The biggest change the Rochester Epidemiology Project is seeing mirrors the nation’s changing demographics. While individuals of Northern European descent have long made up most of Olmsted County’s population, a new wave of immigration now means that one in four children not in the project are not of European descent.

For more information, go to 

State HIE Efforts are Growing

The Missouri Health Connection (MHC), at, the state’s designated entity to implement Missouri’s health information network, and the Illinois Health Information Exchange (ILHIE) are now exchanging Direct secure messages across state lines. By connecting Missouri’s system with the Illinois Direct Secured Messaging Health Information Service Providers (HISP), providers can now send an easy, quick, and secure Direct message.

MHC also announced that it was awarded a $230,000 grant from the Missouri Foundation for Health, a philanthropic organization to fund educational and outreach efforts related to Missouri’s statewide health information network.

The funding will be used to help MHC educate and encourage both consumers and healthcare providers on MHC services and benefits. The funding will provide for training for healthcare system personnel and consumer advocates. Educational materials and strategies will be developed with the input of MHC participating organizations to include the MHC Consumer Advisory Council, Missouri Health Literacy, and other stakeholders.

“This grant will help MHC empower Missourians to take a more active role in their own healthcare”, said Mary Kasal, MHC President & CEO. “We’re very grateful to the Missouri Foundation for Health for their support of this project and our mission to improve patient health through the statewide health information network.”

In another state, the North Arkansas Regional Medical Center (NARMC) a 174 bed hospital is the first to launch the State Health Alliance for Records Exchange (SHARE) at to extend the exchange of electronic patient health information to providers throughout the state.

The statewide exchange of health information will become increasingly efficient as more Arkansas healthcare providers implement SHARE in the near future. Many more Arkansas healthcare organizations will be connecting to SHARE in 2013 with the University of Arkansas’ School of Medicine to begin to transfer clinical data into SHARE by February.   

Telehealth Summit Just Days Away

Insightful discussions on virtual care models across a variety of specialties including diabetes management, tele-ICUs, ocular, pediatrics, and telemental health will take place at the World Congress Telehealth Executive Summit January 28-29, 2013 at the Hilton San Diego Resort and Spa.

Attendees will have the perfect learning environment while examining all of the issues involved in actively pressing forward to effectively use telehealth in today’s healthcare system.

Clinicians, administrators, and case managers will benefit from relevant case studies examining patient outcomes in active telemedicine initiatives as well as expert-led panel discussions on Credentialing, Grants and Funding, Technology and Vendor Selection, and Virtual Care Communication and Management Models.

Attendees will be able to listen to in-depth discussions on:

·        Aligning incentives and reimbursement models to support telehealth programs
·        The impact that the Affordable Care Act and SCOTUS decision will have on the future of telemedicine
·        How to overcome legal and regulatory barriers such as state licensing and credentialing
·        Ways to expand specialty telehealth initiatives to create an enterprise wide strategy
·        Determining ROI and how to improve outcomes from evidence-based case studies
·        Ways to reduce re-admissions and keep patients in their homes using remote monitoring technologies
·        Integrating disparate data sources to achieve interoperability
·        Ways to engage physicians and adapt clinical and workflow efficiently

Keynoter Jay H Sanders, MD, President and CEO, for the Global Telemedicine Group and Professor of Medicine at Johns Hopkins University School of Medicine will present his vision on how to transform healthcare delivery through telemedicine to effectively meet the needs of the 21st century.

Some of the other speakers include:

·        Dale C. Alverson MD, Professor Emeritus of Pediatrics and Regents, Medical Director of the Center for Telehealth and Cybermedicine Research, University of New Mexico
·        Eric Brown President and CEO of the California Telehealth Network
·        Jeffrey P. Kessler, PsyD, Chief Operations Officer at the Georgia Partnership for TeleHealth
·        Nina M Antoniotti R.N, PhD, Telehealth Director for the Marshfield Clinic
·        Ronald S Weinstein MD, Founding Director for the Arizona Telemedicine Program
·        Mario Gutierrez, Executive Director for the Center for Connected Health Policy
·        Nancy Vorhees, Chief Operating Officer for the Inland Northwest Health Services
·        Yael Harris, Director, Office of Health IT and Quality, Office of Special Affairs at HRSA
·        Lisa Robin, Chief Advocacy Officer, for the Federation of State Medical Boards

Plus many more speakers from hospitals, colleges, industry, state organizations will provide their knowledge and insight on the vital and critical issues involving the use of telehealth.

For more information or to register, go to Federal Telemedicine News readers and friends can save an additional $300 off the current registration fee by using Promo Code FTN912 when registering.

Expanding Telehealth Markets

REKA Health Pte Ltd., a Singapore based provider of mobile health technology products and services has opened their U.S. headquarters in the biotech hub of San Diego. Production is being ramped up as REKA Health Inc. prepares to sell telehealth solutions to facilitate remote health monitoring into the U.S. market.

The company exhibited their FDA-cleared E100 cardiac event monitor and cloud platform at the mHealth Summit held in the D.C. area in December. The monitor enables patients who experience transient symptoms suggestive of cardiac arrhythmia to record and store events as they occur using either the standard or integrated platinum thumb electrodes. The user is able to transmit their information on their events to the clinician for diagnosis.

For maximum convenience, users can use the pocket-sized E100 on the go and after recording an ECG, the user simply needs to connect the E100 to a mobile device such as the iPhone or iPad and use the supporting application to upload the ECG reading to the cloud platform.  

The company has also established a foothold in Turkey and partnered with Teletip, the country’s leading provider of telemedicine health services. REKA has also partnered with GSM operator Avea Telecom to launch the first fully integrated GSM healthcare protection system. Marketed under the brand of DRCELL, the EKINOKS system is specifically designed for patients to use in the home and features the E100 ECG event recorder.

For more information, go to

Sunday, January 13, 2013

Bill to Help with HIT Loans

On January 3rd, Representative Nydia M. Velazquez (D-NY) introduced the “Working Families Access to Health Innovations Act of 2013” that would amend the Small Business Act. The bill would provide loan guarantees up to 90 percent of the loan to help eligible professionals in solo and small group practices acquire health IT.

As the Ranking Member of the House Committee on Small Business, Velazquez has made access to capital for entrepreneurs one of her signature priorities.

The loans may not exceed $350,000 for any single qualified eligible professionals or exceed $2,000,000 to any single group of affiliated qualified eligible professionals. Velazquez noted, “Widespread adoption of health information technology can improve the quality of care and make our healthcare system more efficient.”

The bill would also enable Small Business Development Centers to include health IT training and also provide for a network of small health IT companies to help professionals in low income and underserved areas purchase, use, and maintain health IT.

For more information, go to

Safer Devices in the Home

“Home medical devices once were designed only to keep you alive but now they’re designed to keep you as independent as possible” according to Mary Brady, MSN, RN, Senior Policy Analyst at FDA’s Center for Devices and Radiological Health (CDRH).

The FDA has been concerned that consumers may sometimes be dependent upon medical devices that they may not know how to operate and they may not understand the safety risks. There have been serious and even fatal problems reported to FDA associated with medical devices used at home.

FDA is working on ways to help consumers safely operate and maintain home use devices such as blood glucose monitors, infusion pumps, and respirators. The FDA has issued a draft guidance document for manufacturers on the design and testing of devices intended for home use and has developed clearer instructions when the devices are used.

“Using a medical device at home is not as simple as it might sound” as Brady explained. “The device might not come with written instructions that tell a home user how to operate the device safely and how to let the user know if it is not working properly. Even if the device comes with instructions, the language used might be too technical.”

While more medical devices are being specifically designed for home use, there are some devices used at home that weren’t originally designed for use by the average person. “Devices are often designed for the healthcare professional to use in a clinical setting such as a medical office or a hospital” says Brady.

In addition, home use devices designed to be used in medical facilities and not homes might be adversely affected by things found in a home environment such as pet hair, well water, or temperature variations.

Other challenges include the user’s and the caregiver’s physical and emotional health. People taking medications that affect their alertness or memory might have trouble using or taking care of their devices. Similarly, the emotional impact of caring for a loved one might influence the caregiver’s ability to use complex high maintenance devices.

Usability is a critical factor in the design of medical devices. The ECRI Institute an organization that evaluates medical products and processes has found that poor usability were among the top ten health technology hazards of 2012. Examples include users having difficulty with the start or stop button on an infusion pump or the inability to hear different types of alarms in other rooms in a house.

In 2010, the FDA launched their Medical Devices Home Use Initiative. So far, the FDA has:

·        Issued a draft guidance document for manufacturers that describes factors to consider when designing, testing, and developing home use devices
·        Asked device makers to consider the user’s physical condition, consider emotional issues, consider the training needed to use the device, and the home environment where the device will be used
·        Requested that user-friendly instructions be included and also how to handle the device in an emergency
·        Requested that Visual Learning Guides use mostly pictures. The first two guides will be produced over the next two years and will focus on the proper containers to be used to dispose of sharp objects
·        Explored the feasibility of making device labeling available on the internet
·        Created a list of recommended practices, regarding the use of patient lifts to reduce the risks associated when transferring patients from one place to another