The Food and Drug Administration’s proposed health information...
The Food and Drug Administration’s proposed health information technology safety center should focus on the interoperability of mobile medical apps if it is to succeed, said American Medical Association (AMA) Chief Medical Information Officer Michael Hodgkins on the final day…
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of the FDA’s three-day workshop on its recently released health IT framework draft. “The mobile health application environment is the Wild Wild West and nobody has found a sheriff yet,” he said. The health IT safety center, intended as a public-private partnership to do research on health IT best practices, was part of the FDA’s April-released health IT framework, which would alter the government’s approach to Internet-enabled healthcare devices by clarifying which types of devices it should closely scrutinize (CD April 4 p8). The workshop -- organized with help from the FCC and Department of Health & Human Services’ Office of the National Coordinator for Health Information Technology -- was intended to solicit industry and medical community feedback on the draft (CD May 14 p13). Panelists told FDA officials the center must bring in individuals and issues traditionally excluded from these discussions. “I think the people that have been excluded the most are ripe to participate,” AMA’s Hodgkins said. A focus on the entire system “means any information system that contributes to” patient care, said Siemens Principal Health Informatician Jim Walker. That includes mobile apps, websites like PatientsLikeMe and social media sites, he said. Hodgkins said these are problem areas that can’t be overlooked. “We know a lot of these apps are misleading, inappropriate and dangerous in terms of their content,” he said. “We know a lot of these apps are not protecting personal health information, are not secure, and yet they're going to play a vital part [in patient care] going forward, especially as we see a shift in payment model.” These users must be drawn into the safety center, Hodgkins and Walker agreed. Having the safety center concentrate on usability and interoperability is an effective way to get them engaged, said Hodgkins. Walker suggested a model similar to the National Transportation Safety Board’s voluntary multistakeholder group, which “receives input from all across the system” on “hazards that haven’t yet become incidents,” producing reports for the government agencies.