A new workgroup focusing on patient safety and innovation in health IT will begin meeting next week, and mobile medical applications are sure to be on the agenda.
The workgroup was unveiled by the Department of Health and Human Services and Federal Communications Commission last week. It will report to the Health IT Policy Committee, which advises the Office of the National Coordinator for Health IT, and hold its first meeting on April 29.
The workgroup’s membership consists of agency officials and experts representing patients, consumers, healthcare providers, startup companies and health plans or other third-party payers. It also includes venture capital investors, information technology vendors, health information technology vendors, small businesses, purchasers, employers and other stakeholders.
Several members of the mHealth community are included in this group, among them Robert Jarrin of Qualcomm, T. Drew Hickerson of Happtique, Health Hero co-founder Geoffrey Clapp, Jonathan Potter of the App Developers Alliance, Jackie McCarthy of the CTIA, Joseph Smith of West Health and Bradley Thompson of the law firm of Epstein Becker Green.
"Patients already benefit from innovative information technology tools such as electronic health records that allow their providers to improve coordination and delivery of care," HHS Secretary Kathleen Sebelius said in a news release. "This workgroup will help the Health IT Policy Committee consider new ways to navigate this rapidly growing industry while promoting innovation and protecting patient safety."
"New technologies can revolutionize healthcare, helping to improve patient outcomes, while expanding access, creating convenience and lowering healthcare costs for millions of Americans," added FCC Chairman Julius Genachowski in a statement. "We anticipate that this talented group of leaders from their respective fields of discipline will help to bring fresh ideas to the table with an eye towards ensuring patient safety."
The Food and Drug Administration's Safety and Innovation Act directed the HHS Secretary, acting through the commissioner of the U.S. Food and Drug Administration and in consultation with the ONC and the chairman of the FCC, to develop a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework for health IT, including medical mobile applications, that promotes innovation, protects patient safety and avoids regulatory duplication. The FDA, FCC and ONC will review the recommendations from the Health IT Policy Committee, based on input from the workgroup, as they write the report.
The workgroup meetings will provide opportunities for the public to comment. Documents discussed by the workgroup will be available on the ONC website.
The FDASIA Workgroup consists of:
- David Bates, Brigham and Women’s Hospital, Chairman;
- Patricia Brennan, University of Wisconsin-Madison;
- Geoffrey Clapp, founder of the mobile health startup Better;
- Todd Cooper, Breakthrough Solutions Foundry;
- Meghan Dierks, Harvard Medical faculty, Division of Clinical Informatics;
- Esther Dyson, EDventure Holdings;
- Richard Eaton, Medical Imaging & Technology Alliance;
- Anura Fernando, Underwriters Laboratories;
- Lauren Fifield, Practice Fusion;
- Michael Flis, Roche Diagnostics;
- Elisabeth George, Philips Healthcare;
- Julian Goldman, Massachusetts General Hospital/ Partners Healthcare;
- T. Drew Hickerson, Happtique;
- Jeffrey Jacques, Aetna;
- Robert Jarrin, Qualcomm;
- Mo Kaushal, Aberdare Ventures/National Venture Capital Association;
- Keith Larsen, Intermountain Health;
- Mary Anne Leach, Children’s Hospital Colorado;
- Meg Marshall, Cerner;
- Mary Mastenbrook, consumer advocate;
- Jackie McCarthy, CTIA - The Wireless Association;
- Anna McCollister-Slipp, Galileo Analytics;
- Jonathan Potter, Application Developers Alliance;
- Jared Quoyeser, Intel;
- Martin Sepulveda, IBM;
- Joseph Smith, West Health;
- Michael Swiernik, MobileHealthRx;
- Paul Tang, Palo Alto Medical Foundation; and
- Bradley Thompson, Epstein Becker Green P.C.
In addition, Jodi Daniel of the ONC, Bakul Patel of the FDA and Matthew Quinn of the FCC will serve as ex officio/non-voting members of the workgroup.
