A newly formed public stakeholder group tapped to advise three federal agencies on establishing a government framework for regulating Health Information Technology and mobile medical apps hopes to post recommendations by early August.

The FDA Safety and Innovation Act work group, a new segment of HHS’ established Health IT Policy Committee, met for the first time via teleconference April 29, setting out goals and timelines.

The topic of health IT regulation has been a hot one. The Bipartisan Policy Center offered suggestions on a health IT framework earlier this year. (See [A#01130225008].). Also, Congress held several hearings on the topic in March. (See Also see "FDA Reiterates Intention To Regulate Only A Small Portion Of Mobile Medical Apps" - Medtech Insight, 25 March, 2013..) FDASIA, enacted last year, mandated the release of a report by January 2014 from FDA, the Federal Communications Commission and HHS’ Office of the National Coordinator for Health Information Technology detailing the government’s position.

The work group was also authorized by FDASIA to ensure the agencies gained public input before issuing the report. (See Also see "Government Agencies Form Work Group To Develop Health IT Framework" - Medtech Insight, 11 March, 2013..) It formed recently with 29 members, including industry and venture capital representatives, health care providers, attorneys and more. Among the members are executives from Philips Healthcare, Roche Diagnostics, Qualcomm, Intel and IBM. Representatives from ONC, FCC and FDA are serving ex officio.

The work group efforts begin as FDA is pressing to finalize a guidance document for regulating mobile medical apps by the end of the year, and, in parallel, is considering its role in the oversight of other health IT software tools. (See Also see "Challenges Abound In Creating Regulatory Framework For Mobile Medical Apps, Health IT" - Medtech Insight, 1 October, 2012..) ONC, meanwhile, is active in establishing health IT and device interoperability standards for health care providers. And FCC is increasingly establishing policies tied to wireless use of medical devices. (See in this issue Also see "FCC Simplifies Process To Access Wireless Spectrum For Device Clinical Trials" - Medtech Insight, 6 May, 2013..)

The three main goals of the eventual framework are to “promote innovation, protect patient safety and avoid regulatory duplication,” suggested Jodi Daniel, director of ONC and an ex officio group member. Her colleague, Farzad Mostashari, the national coordinator at ONC, told the group members that he wanted health IT regulations to “embrace market-based approaches but to make sure we also protect the little guy as we do so” and “put the patient in the center, and their interests, in the center of everything we do.”

“Many types of health IT may be a medical device as a matter of law, but we firmly believe that we should not enforce FDA requirements on most of them” – CDRH Director Jeffrey Shuren

Matthew Quinn, the new director of health care initiatives at FCC, represented his agency’s interests at the meeting, saying that the surge in innovation “highlights and elevates concerns around [radiofrequency] interference, reliability of access, usability, and security.”

David Bates, chief quality officer at Brigham and Women’s Hospital, Boston, who is serving as chair of the work group, called the challenges facing the group and the agencies “wicked” due to the complexity of balancing safety, innovation and commerce. “[We] need to break down the problem into meaningful chunks; that will be [the] key next thing that we do,” he said.

Shuren Seeks “Smart Regulation”

Jeffrey Shuren, the director of CDRH, also spoke on the teleconference, outlining his hopes for so-called smart regulation.

“To us, smart regulation means applying the tools available to the FDA based on using a risk-based approach that achieves the often complementary goal of protecting patient safety and security and facilitating innovation,” he said.

“Smart regulation also means recognizing when not to regulate. Many types of health IT may be a medical device as a matter of law, but we firmly believe that we should not enforce FDA requirements on most of them.”

He said that the 2011 draft guidance on mobile medical apps exemplified his ideas for smart regulation well, and elaborated that he hoped FDA could finalize it “very soon.” Office of Device Evaluation Director Christy Foreman said at a Politico-sponsored meeting April 30 that FDA plans to issue the final guidance by October.

Shuren also outlined a shift in thinking with standalone medical device software, with more of a focus “on assuring that appropriate processes for software validation and verification are in place, and less on traditional pre-market review, including the review of software modifications.”

“We believe that even for many types of standalone medical device software we do regulate, we need to apply a lighter touch that appropriately takes into account the business models for, and the lifecycle of software development and maintenance,” he continued.

The CDRH director said he hoped that the committee could provide its expertise on clarifying the gray areas where enforcement discretion begins and ends, for instance, “which types of standalone medical device software with clinical decision support functionality we should, and which types we should not actively regulate, based on level of risk.”

Shuren also signaled that, even for health IT falling under enforcement discretion, some degree of surveillance would apply.

“For those health IT [software] that are medical devices, but which we have decided as a matter of policy not to actively regulate, but regulate only in part, [we’re asking] how to best leverage the available tools, authorities and expertise of the other agencies – if at all – to protect patient safety and facilitate innovation.”

Advice: “Shoot For The Stars,” But Not Too High

Work group members took the opportunity of the first meeting to probe, ask questions and discuss the parameters and scope of the task expected of them.

Attorney Bradley Thompson, representing the industry’s mHealth Regulatory Coalition, asked officials how far outside the box the work group could stray. “Are we required to think within existing statutes or, if anything we suggest implicates a legislative change, how do we handle that?”

Agency representatives replied cautiously. Bakul Patel, a policy advisor with CDRH, advised members, “Shoot for the stars, but make sure it’s practically applicable or implementable.”

For his part, ONC’s Mostashari encouraged outside-the-box thinking, as long as it was clearly labeled as such. He also advised members to give some “meat and potatoes” as more practical suggestions.

Group member Esther Dyson, a venture capitalist with EDventure Holdings, suggested that the work group rethink risk as medicine shifts to a more personalized model. “The regulatory framework needs to shift to understand that,” she stated.

ONC’s Daniel was receptive. “My thought is we need to have a very rich and thoughtful conversation about risk; … How do we characterize the risk, how do we think about risk, and how does that impact a framework that that develops to manage that risk? That’s on point and I look forward to that conversation.”

Julian Goldman, an anesthesiologist at Massachusetts General Hospital, Boston, who researches device and electronic health record interoperability issues, prodded the committee about the lack of safety data associated with various forms of health IT, calling the documentation “scattered.”

Bates, the group’s chair, agreed that the safety data was “quite incomplete” but, “We probably will not be gathering additional data in this process given our timeframe, and we’ll have to make some suggestions recognizing we don’t have all the data that we would really like,” he said. He also noted that recommendations could be made to encourage the collection of more safety data in the future.

Next Up

“Looking at the schedule, I already feel time pressure and it’s just been our first call,” Bates said.

The group is aiming to post its recommendations on ONC’s website by Aug. 7, followed by an in-person presentation Sept. 4. To reach that goal, the work group is planning to hold its next teleconference May 6 and an in-person meet-up later in the month. Two more meetings will follow in June, though no dates or times have been set.

Assuming the group meets its time goals, the agencies will have about four to five months to put together the required framework document by next January.

HHS Health IT Regulations Work Group Sets Path Forward

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