New quality reporting measures require enhanced health IT infrastructure. Digital health platforms for quality measurement and reporting see increased demand.
ACTION: Position HealthTech members as quality reporting solution providers. Brief CMS on digital health quality measurement innovations.
$14.2B in total OPPS payments (CY2027)
PositiveSec. HR-5012 · Legislative — Medical Devices
Medical Device Innovation Act
AI/ML continuous learning framework validates HealthTech's regulatory approach. 6 member companies have AI diagnostic products awaiting clearer regulatory pathway.
ACTION: Coordinate with MedDevice Alliance on joint advocacy. Prepare AI/ML device case studies for congressional education. Brief Young and Heinrich offices.
Telehealth permanent flexibilities and rural infrastructure fund create major market opportunity for HealthTech telemedicine and remote monitoring platforms.
ACTION: Position HealthTech members as rural telehealth solution providers. Brief Young office on digital health rural access innovations.
$3.8B over 5 years
PositiveSec. FDA-2026-D-0234 · FDA Regulatory Guidance
AI/ML-Based Medical Device Guidance
Landmark guidance provides regulatory clarity HealthTech has sought for 3+ years. Predetermined change control plan framework enables continuous AI model improvement without full re-review.
ACTION: File supportive public comments with specific implementation recommendations. Coordinate member company case studies for FDA workshop. Brief Lieu and Young offices.
Quality rating infrastructure requires advanced health IT platforms. HealthTech members positioned as implementation partners for states and managed care organizations.
ACTION: Develop state-by-state market opportunity analysis. Brief member companies on RFP timelines. Coordinate with CMS Innovation Center on pilot partnerships.