Lobbyists eye MDUFA as vehicle for AI, digital health policies

Digital health lobbyists are exploring ways to get their priorities into device user fee riders that could include artificial intelligence and digital health wishlist items such as a federal clinical AI sandbox and clearer rules for software related to prescription drugs and devices.

The Consumer Technology Association (CTA) “is in the early stages of thinking through MDUFA priorities regardingAI and digital health and is working with stakeholders," a spokesperson for the trade group told Inside HealthPolicy.

The Health Innovation (HIA), Connected Health Initiative (CHI), Healthcare Information and Management SystemsSociety (HIMSS) and ATA Action are also among the DC digital health advocacy groups that are exploring possibleAI and digital health riders to Medical Device User Fee Amendments (MDUFA) VI.

Some of those groups also see possibilities for a third reconciliation budget to include AI and digital health policy, though lobbyists widely report they do not expect Congress to take up such a bill and some senior GOP senators are casting doubt on the bill’s prospects.

“We don't see [MDUFA] as the only path. We're working with Congress, agencies, and stakeholders across the board, and progress could come through MDUFA, standalone legislation, reconciliation, a year-end package, or other vehicles that emerge,” Lani Reilly, vice president for industry affairs at ATA Action, told IHP.

Other groups, however, share the consensus opinion that a reconciliation package is not a likely legislative vehicle for AI and digital health.

“HIA sees limited opportunity for major AI or digital health reforms in reconciliation. There may be narrow openings in a continuing resolution or end-of-year package, but those vehicles are more likely to carry ready-to-movepolicies than transformational health tech reforms,” HIA Executive Director Roslyn Docktor told IHP.

It is also challenging to get AI and digital health reforms into reconciliation because of the Byrd Rule prohibiting a budget bill from including policies deemed “extraneous” to changing the federal budget, another digital health lobbyist said.

Unlike reconciliation, MDUFA reauthorization is considered must-pass legislation by Sept. 30, 2027, because without a bill, FDA’s ability to review medical devices would be hamstrung.

MDUFA’s must-pass nature makes a reauthorization bill an attractive option for AI and digital health policymaking, Carrie Nixon, managing partner of Nixon Law Group, said.