The Food and Drug Administration's list of guidance priorities for 2015 indicates the agency will focus on further clarifying its regulatory stance on a range of healthcare technology areas such as accessories and decision-support software, among others.
The agency divides its guidance list into two tracks: the A-list, which the agency feels are more likely to be published this year; and the B-list, which the agency hopes to publish in the coming year. The A-list for draft guidance includes several health information technology priorities, including wellness, accessories, decision-support software and some fine-grained guidance on unique device identifiers. FDA guidances are the agency's interpretation of rules which the industry must follow.
Somewhat surprisingly, given the government push for it, draft guidance on interoperability has been relegated to the B-list, as has 3-D printing.
“It might be that the FDA expects other agencies will take the lead on interoperability, and perhaps they are planning to play a more supportive role,” speculated Bradley Merrill Thompson, a lawyer with Epstein Becker Green and a representative of several industry groups supporting health IT. The FDA would likely be involved in issues surrounding interoperability between devices and software.
Still, he saw the FDA's other outlined priorities as positive for healthcare overall.
The other guidances, if released, should wrap up many of the questions left unanswered by a health IT regulatory draft framework released last spring. A critical question in that framework has been the blurred line between FDA-regulated and Office of the National Coordinator for Health Information Technology-overseen clinical decision-support software. The initial draft only stated that “most” software would be overseen by the ONC.
The FDA's language in describing the software was interesting, noted Dan Haley, vice president of government and regulatory affairs at athenahealth, since it described “medical device” clinical decision-support software, which may reflect the FDA's intent to oversee only a limited slice of the sector.
Agency guidance on wellness and accessories also could resolve other longstanding issues. Application developers in particular have long been wary of tripping over FDA's rules regarding […] promotion. For example, an app intended to help patients manage their weight would typically be unregulated, given that it is intended for general wellness.
However, a developer might run into trouble attempting to promote a general-use application for weight management to a population with a disease. The agency might consider that marketing improper without evidence to back the app's claims. Many developers are hoping for clarification of what wellness marketing is acceptable.
The issue of accessories also is important for developers. The question for some developers is when a general-use accessory—say, a cord connecting a device and a smartphone—requires strict FDA regulation.
The bevy of guidance surrounding health IT comes as Congress is considering several bills to substantially change the sector's regulation and, in particular, the FDA's potential oversight role.
The agency's guidance priority list “seems odd since Congress is going to change the law,” said Joel White, executive director of trade group Health IT Now. White has generally supported legislative action to change the laws that apply to the sector.
Follow Darius Tahir on Twitter: @dariustahir