FDA looking at Smartphone Applications as Medical Devices:
A large number of apps for smartphones, particularly the iPhone (Apple) & Android (Google) phones, are targeting medical functions and processes. One recent app that has come under a lot of scrutiny is iStethoscope. This is an application that turns an iPhone into a high-tech stethoscope that listens to heart sounds (as well as many other bodily sounds) and records them, produces statistics and plots the sounds as a waveform. It was developed by a team of cardiologists and Peter Bentley, a computer scientist at University College, London. The FDA is beginning to evaluate these applications to determine if they should be regulated as medical devices. FDA’s scrutiny is based on the premise that any computer-based application that makes diagnoses (or substantially assists in diagnosis) or transmits medical images is a medical device and should be regulated as such. This is important to community-based providers and health centers for two reasons: first, smartphones may be a (comparatively) inexpensive way to meet many meaningful use criteria, especially those related to referrals and patient communications. If they additionally could take over the function of many current simple medical devices, that could be both effective and cost-efficient. If, however the FDA regulates these applications, they may delay or limit innovation and make it harder to meet HIT goals. The same may be true if the FDA regulates EMRs (as has been highlighted here previously). See FDA has App Stores Under Surveillance .
“Blue-Button” to Allow Patients to Access Their Health Records:
Markle Connecting for Health, a public-private collaborative, announced recommendations for “Blue Button” access to enable patients to download personal medical information such as doctor-visit summaries, medication history and lab results. This initiative is timely as the U.S. Veteran’s Administration and Medicare prepare to implement electronic health record access for beneficiaries this year. Pushing the Blue Button would require a consumer to answer some questions in order to authenticate themselves and acquaint them with their responsibilities for security of the downloaded information. It would then allow them to specify what information to download. More than 50 companies and organizations have committed their support to the principles,, first released as in 2006 as part of Markle’s “Common Framework for networked personal Health Information,” and detailed in Markle Foundation’s August Policy Brief “Health Information…at the click of a blue button”
Making the Most of Your EMR:
A recent article in Hospital & Health Network Magazine by Daniel Marino, An EMR that Pays for Itself, makes an important point about EMRs and sustainability that is immediately relevant to community health centers. In order for an EMR to not be merely a sunk cost (with cost incurred for acquisition, deployment, training, workflow revision etc.), providers must develop new processes and uses for EMR-based information. Such processes might include: creating more connectivity among clinical staff for referrals, care coordination and clinical communications of all kinds, facilitating patient communication to make information available and importantly to provide alerts and reminders, integrating the EMR with Federal and State quality reporting and public health programs and finally mining the data in the EMR for outcomes to be analyzed as part of clinical improvement initiatives. Many of these processes are related to meaningful use criteria in Stage 1 or subsequent stages, but there is an opportunity to go beyond meaningful use to create new processes and uses that have the potential to more effectively improve outcomes
Fair Information Practices ONC’s HIT Standards Committee Recommendations from August 2010 Meeting:
The Standards Committee of the Office of the National Coordinator met on August 19th 2010 and provided a recommendations letter addressing a host of issues, including information exchange through intermediaries or third party services, such as health information exchanges or HCCNs. The basis for these recommendations are the Fair Information Practices described in ONC’s Nationwide Privacy and Security Framework Key among the group’s ten recommendations are :
- Responsibilities of third party organizations – Intermediaries must use personally identifiable health information (PIH) only for those purposes specified in the business associate, data sharing or service agreement with the provider. They must be transparent about such agreements, and may retain PIH for only as long as necessary to provide the function(s) specified in the agreements.
- Provider’s responsibilities – The responsibility for the privacy of PIH rests with the patient’s provider who may delegate such tasks as digital credentialing and provider verification to additional third parties
- Information exchange for treatment – Health information exchange for treatment purposes will not require additional patient consent. Additional patient consent is required when the organization providing the exchange retains PIH and makes that information available to other parties, the organization providing the exchange operates as a federated model and exercises its own control over access to patient data, or the information is aggregated outside the control of the provider or the organization providing the exchange.
The Work Group also discussed whether patients should be able to exercise more granular control over release of PIH and concluded that while this would be desirable, it was not technically feasible at this time.
eHealth Initiative Releases First Regional Extension Center Survey:
ehealth Initiative (eHI) has released a survey of Regional Extension Centers (RECs) titled, “Planning for Adoption: The Early Direction of Regional Extension Centers “summarizing information gleaned from 46 of the 60 RECs funded by the HITECH Act. This early eHi Survey includes responses from RECs still in the planning stage; eHI intends to continue survey the Centers and update this work as needed. Among the findings:
- Many RECs are working with other federally funded HIT programs, most commonly: state- designated entities for HIE, HIT workforce training programs, Medicare DOQ-IT and Beacon Communities.
- Of 32 RECS responding to this question, 18 reported that no providers signed contracts after signing letters of commitment in the application process. Of the remaining 14respondenets, only 5 had over 50% of their committed providers sign contracts.
- Almost all RECs plan to recommend EHRs to their participating providers. All but a very few intend to recommend multiple (up to 8-10) EHRs. The most important criteria for recommendation will be: price/total cost of ownership, guarantee of providing meaningful use criteria, local implementation-deployment capability, number of local installations and ASP hosting model.
- Half of the RECs surveyed will offer a subscription model with tiered services, 40% will offer an hourly service model and 10% will offer a flat-fee model.
- Current fees and costs range from $400-$2000 per provider/per year.
- Most (65%) of RECs anticipate increasing their fee schedule after the majority of the Federal subsidy is spent ($598 million allocated for the program’s first two years, $45 million for the last two). Sustainability after the end of Federal funding is seen as an important issue.
DHHS Awards $17 Million for Patient-Centered Outcomes Research:
On Septemebr1, HHS Secretary Sebelius announced nearly $17 million under three grant programs for patient-centered outcomes research (PCOR) to evaluate treatments and strategies and drive outcomes improvement. The Health Services and Research Administration will establish a network of PCOR centers, including research in pediatric medicine. Importantly, HRSA will be supporting the capacity of community-based providers to engage in this type of research. One of the first recipients is Fenway Community Health Center in Boston, with a grant of $1.9 million. The HHS release details the grantees and programs.
Final Two “Beacon” HIT Pilot Communities Announced:
DHHS Secretary Sebalius and National HIT Coordinator David Blumenthal, M.D. were on hand in Cincinnati and Detroit September 2nd to personally announce the two final communities selected under the new “Beacon Community Program”, joining 15 other projects previously named in May. Greater Cincinnati HealthBridge, Inc. will receive $13.8 million over three years, and Southeastern Michigan Health Association (SEMHA) will receive $16.2 million during the same period. As detailed in the HHS press release a total of $265 million is being spent on the 17 Beacon Communities including a major research and evaluation component. The program is designed to allow HHS to look for new ways to share the lessons learned by funded communities and develop, working with local and national health care foundations, support networks for other communities that want to employ similar innovative approaches.
Community Health Centers are urged to look into the 17 targeted communities for collaborative opportunities.
DHHS Launches Spanish-Language Website with Health Reform Insurance Information:
On September 8th, DHHS launched a new Spanish-language web site to assist consumers in understanding their public and private sector health insurance options under the new healthcare reform legislation.
“CuidadoDeSalud.gov, like HealthCare.gov, is an unprecedented website which provides consumers with the power of information at their fingertips. Individuals, families, and small businesses will be able to easily compare both public and private health coverage options tailored specifically for their needs, said HHS Secretary Kathleen Sebelius. “CuidadoDeSalud.gov will give Latinos across the nation better information about the choices they have, how much they cost, and what they can expect from their doctor–specific to their life situation and local community.” Starting in October, CuidadodeSalud.gov will begin providing price estimates for various insurance options.
DHHS Announces $20 Million for Regional Extension Centers to Help Rural Healthcare:
On September 10th, HHS Secretary Sebelius announced that $20 million in additional ARRA funding would be available to assist rural critical access hospitals and rural hospitals with less than 50 beds in selecting and implementing certified EHR systems. Through the Regional Extension Centers, about 1,655 critical access and rural hospitals in 41 states and the nationwide Indian Country, headquartered in the District of Columbia stand to benefit from this special assistance. Total funding available now to Regional Extension Centers to date now exceeds $663 million. Click for the HHS release RECS for rural and critical access hospitals.
Opportunity to Listen in on Public Policy and Standards Committee Deliberations:
Community, Indian and Migrant Health Centers that want to learn more about the specific directions being taken with regard to policy and standards issues under HITECH should plan to attend one or more of the following meetings via phone and/or web. Get a firm understanding with regard to particular areas of interest. Be sure to mark the following Federal Advisory Committee (FACA) meetings on your calendars! See the ONC Website for information on how to participate via phone or web, or how to find the location of the public hearings (indicated with an asterisk *) which will be held at hotels in the Washington DC metro area.
HIT Policy Committee Meetings
- Information Exchange Workgroup, Sept 13, 11 am to 2 pm/EDT
- HIT Policy Committee*, Sept 14, 10 am to 3 pm/EDT
- Crystal Gateway Marriott, Arlington, VA
- Meaningful Use WG*, Sept 22, 8:30 am to 4 pm/EDT
- Park Hyatt Washington, Washington, DC
- Enrollment WG, Sept 24, 11 am to 2 pm/EDT
- Privacy & Security Tiger Team, Sept 24, 3 pm to 5 pm/EDT
- Governance WG*, Sept 28, 9 am to 5 pm/EDT
- Washington Marriott Wardman Park Hotel, Washington, DC
- Quality Measures WG, Sept 29, 2 pm to 5 pm/EDT
- Information Exchange WG*, Sept 30, 9 am to 4 pm/EDT
Location to be determined.
HIT Standards Committee Meetings:
- Implementation WG, Sept 15, 12 pm to 2 pm/EDT
- HIT Standards Committee*, Sept 21, 9 am to 3 pm/EDT
- Washington Marriott Wardman Park Hotel, Washington, DC
- Vocabulary Task Force, Sept 23, 10 am to 11:30 am/EDT
- Clinical Operations WG, Sept 23, 12 pm to 1:30 pm/EDT
Healthcare CIOs Cautiously Optimistic about Receiving EHR Incentive Funds:
A newly survey, released September 10th by the College of Health Information Management Executives (CHIME) concludes that its members are cautiously optimistic about their ability to qualify for Stage 1 stimulus funding under HITECH. Of 152 members who responded, 28 percent said they expected to qualify in the first six months of fiscal year 2011 (starting October 1, 2010) and another 62 percent reported that they anticipate qualifying between April 1st, 2011 and September 30th, 2012 – which marks the end of the Stage 1 portion of the program. CHIME is executive organization dedicated to serving chief information officers and other senior healthcare IT leaders including more than 1,400 CIO members. More details in the CHIME release
The current issue of the Journal of Ambulatory Care Management (October –December 2010):
Features an article on how investments in community health centers can bolster efforts to create a Nationwide Health Information Network to better utilize the available data. Click for an abstract of the new JACM article, by Peter Shin, Emily Jones, Reed Tuckson M.D., and RCHN CHF EVP/ COO Feygele Jacobs, titled “Building a National Data Repository to Measure and Improve Health Center Quality”