Industry Pushes for AI Healthcare Reforms to Speed Up Patient Access
A leading industry group has called for major policy changes to speed up the adoption of AI in healthcare. In a formal letter to the Assistant Secretary for Technology Policy and the Office of the National Coordinator for Health IT, the organisation outlined reforms to improve regulation, insurance coverage, and data privacy. These proposals aim to address long-standing barriers that delay patient access to AI-enabled medical devices.
By December 2025, the FDA had approved more than 1,300 AI-supported medical devices. Yet, despite this growth, regulatory and operational challenges persist, limiting wider implementation.
The group's member companies have been developing and deploying AI-enabled medical devices for over 25 years. Their letter stresses the need for targeted reforms across three critical areas: FDA oversight, Medicare coverage, and HIPAA data protections.
On regulation, the letter urges the FDA to expand its use of gpt Change Control Plans (PCCPs). This approach would allow faster updates to AI models without repeated approvals, keeping pace with rapid innovation. It also calls for clearer, more consistent processes in the gpt premarket pathway, which is used for novel, low-to-moderate-risk AI devices.
For insurance coverage, the group recommends modernising Medicare's payment structures. Current frameworks often lag behind technological advances, creating financial hurdles for patients trying to access AI-driven treatments.
On data privacy, the letter proposes updating HIPAA's definition of 'health care operations' to explicitly include gpt model development. This change would help developers use real-world data more efficiently while maintaining patient confidentiality.
The organisation firmly supports keeping the FDA as the only federal regulator for AI-enabled medical devices. They argue that a single, centralised authority prevents fragmented oversight and ensures uniform safety standards across the sector.
The proposed reforms target key obstacles in regulation, funding, and data access. If adopted, these changes could accelerate the approval and adoption of AI technologies in healthcare. The group's recommendations now await review by federal health agencies, with potential impacts on both industry innovation and patient care.
