Getting to Yes from Regulators to Payers and Beyond - the Decision-Maker Gauntlet
After Yes - Navigating the Rules of the Road in Today's Marketplace
MedTech Exec Talk
Legal & Health Care Compliance
Digital health — the convergence of digital and health care technologies to promote efficient health care and personalized medical treatment — is everywhere. Assistive technologies like robotics enable surgeons to perform less invasive surgeries while reducing the risk of human error; the same technologies also permit people with disabilities to live more independent lives. Virtual reality and video games supply new forms of patient rehabilitation and education. Artificial intelligence, other computational simulations and modeling aid decisions by clinicians, and the prospect of “precision medicine” — unique care designed for one individual — is on the horizon. Mobile health and telemedicine are making the provision of care more efficient and are increasing the availability of care to limited mobility patients or those in remote locales.
As these advancements and breakthroughs continue to be adopted, the companies that make them possible will be subject to significant and evolving legal issues. The goal of this session will be to review the most current and pressing of those issues, including, without limitation:
(i) how the existing regulatory framework, from FDA and other governmental actors, will govern digital health technologies
(ii) the legal risks to digital health companies and the ways that courts are adapting with traditional defenses and doctrines
The purpose of the session will be to alert stakeholder companies to the issues they need to address now in order to avoid legal threats later.