On Wednesday, lawmakers on the House Energy and Commerce Committee released new draft legislation that would alter FDA’s oversight of health software products, but leaves out provisions on interoperability and telehealth, Modern Healthcare reports (Tahir,Modern Healthcare, 4/29).
Background
In January, Committee Chair Fred Upton (R-Mich.) and Rep. Diana DeGette (D-Colo.) unveiled a discussion draft for the “21st Century Cures” initiative. While the discussion draft focused largely on FDA and safeguarding medical device innovations, it contained several health IT-related proposals.
Specifically, the draft included:
- A proposal from Health Subcommittee Chair Joe Pitts (R-Pa.) that would require NIH grant recipients to share their data;
- Language from an Energy and Commerce workgroup that seeks to expand Medicare beneficiaries’ access to telehealth services; and
- The SOFTWARE Act, which would develop a regulatory framework for FDA’s oversight of health IT (iHealthBeat, 4/16).
According to The Hill, the updated bill is the result of more than one year of negotiations between DeGette, Upton and dozens of other stakeholders and officials (Ferris, The Hill, 4/29).
Details of New Draft Legislation
Among other things, the latest draft bill includes a revised SOFTWARE Act, which defines the types of health software that would not be subject to FDA oversight. In addition, the SOFTWARE Act outlines exceptions when the agency could determine if a product “poses a significant risk to patient safety” (Gold, et al., “Morning eHealth,” Politico, 4/30).
The bill also includes an additional $10 billion in funding for NIH over the next five years, which would bring the agency’s annual budget total to $31.8 billion in fiscal year 2016 and $34.8 billion by FY 2018. According to The Hill, the bill includes an annual $2 billion “innovation fund” for NIH through FY 2020 (The Hill, 4/29). According to Modern Healthcare, the fund would be used:
- To advance precision medicine efforts;
- To support emerging scientists; and
- For unidentified medical innovation initiatives.
However, the draft legislation omitted language on interoperability and expanding Medicare beneficiaries’ access to telehealth services (Modern Healthcare, 4/29). The package stated such proposals will be released “shortly.”
Next Steps
On Thursday, the full committee is scheduled to meet to discuss the draft bill with FDA and NIH officials.
According to The Hill, the House committee worked to draft the measure and a Senate committee has been working separately on a similar medical innovations bill. The Senate committee said shortly after the House legislation was unveiled that it is forming a bipartisan working group to focus on improving electronic health records, which was left out of the House bill (The Hill, 4/29).
Reaction
In a statement, Health IT Now Executive Director Joel White praised the new draft legislation for clarifying “how innovative new health IT products will be regulated into the future.” He noted that the SOFTWARE Act will help to simplify FDA regulations and “spur development of new and innovative health IT products.”
White also appeared optimistic about the panel’s commitment to working on the details of interoperability and telemedicine, noting, “The fact that interoperability and telemedicine were kept in the draft legislation confirms the committee’s desire to find solutions for both issue” (Health IT Now statement, 4/29).
Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, called the revised SOFTWARE Act a “worthwhile change,” noting that it “does away with the idea of creating a separate category of FDA-regulated software to get special treatment. Instead, the new draft would direct FDA to come up with a new approach for regulating any kind of software the agency regulates” (“Morning eHealth,” Politico, 4/30).
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