WLSA is dedicated to accelerating the adoption of technology-enabled solutions for personal health and health care. To achieve this goal, WLSA actively supports initiatives by affiliated organizations to improve the market for connected health. We are leading a patient-centric redesign of the process for bringing medical products to market while continuously evaluating their safety and efficacy.
The connected health community, which includes the life sciences sector and many new entrants to health care, is prolific in the creation of tech-enabled products that have the potential to cure disease, manage chronic conditions and empower personal health maintenance. The market is developing with investors and large major companies investing. Leading health care providers are intent on improving their outcomes and cost profile and patients/consumers are involved. Health care is becoming a participatory activity.
Several policy barriers are slowing market development. Key issues include the system for regulating medical products (FDA and ONC), the payment model for medical products and services (CMS, private payors), and state restrictions on the practice of interstate telehealth. WLSA’s primary focus is on eliminating key regulatory barriers to useful innovation. WLSA believes that the empowerment of engaged health consumers by connected health platforms will deliver the political power necessary to effect necessary changes.
Key Regulatory Issues:
The U.S. government and health care industry are engaged in a complex set of conversations, proposals and negotiations about the regulation of connected health tools, including software, devices and cloud services. The 113th Congress and relevant agencies are involved, including FDA, FCC and the Office of the National Coordinator for Health IT (ONC), as are health IT, medical device, telecommunications and consumer sectors. Substantive debate issues include:
- When is software, including applications and decision support platforms, to be regulated as a medical device?
- Where is the dividing line between the diagnosis and treatment of disease, which are subject to regulation by FDA, and wellness products, which are exempt?
- If a non-regulated device is used in conjunction with a medical device (including regulated software), when does this device become subject to regulation by the FDA as an accessory?
- How should clinical decision support software (e.g. “Dr. Watson”) be regulated, if at all?