The latest digital health innovations are raising the bar on precision, portability and personalization. Treatment guided by genetic testing, wearables and at-home health care concierge are a few examples of advancements that are redefining care. Further, the COVID-19 pandemic has accelerated the arrival of the digital era in many aspects of global health care. It is evident that without an evolution of regulatory frameworks to recognize this paradigm shift, the benefits of digital health technologies innovations in global medical product development will be delayed to the disadvantage of consumers and patients.
The Medical Device Innovation Consortium (MDIC) is bringing together stakeholders such as medical device and diagnostics manufacturers, regulators, consumer technology firms, patients and patient advocates, clinical institutions, standard development organization and academic research groups to build innovative tools and resources to advance the adoption of digital health.
In this panel session, experts from the Food and Drug Administration (FDA), a consumer electronics and fitness firm, a medical device manufacturer as well as patient advocates brainstorm on existing regulatory framework for digital health, key considerations for patients and health care providers, and implications for the future of digital health innovation.
Heidi Dohse | Tour de Heart
Eric Friedman, BS, MS, VP of Research | Google
Jon Hunt, PhD, Vice President, Clinical Science and Technology | MDIC
Bakul Patel, MS., MBA, Director for Digital Health Center of Excellence | FDA | CDRH
Joseph Sapiente, Associate Vice President, Case for Quality | MDIC
Cassie Scherer, JD, Director of Regulatory Policy, U.S. | Medtronic
Jithesh Veetil, PhD, Program Director, Data Science and Technology | MDIC