‘Digital health is a relatively new, not always well-understood concept’
CHICAGO – Lisa Schmitz Mazur and Bernadette Broccolo, attorneys at McDermott Will & Emery, serve as editors of the new book, “The Law of Digital Health,” which helps digital health leaders and advisors navigate current and evolving laws, regulations and policy, and enforcement developments in the industry.
Mazur recently discussed the things digital health leaders need to know to keep up with rapidly changing legal and regulatory issues.
HHTN:What was the impetus for the new book?
MAZUR:We found that people are familiar with the individual pieces of the digital health ecosystem, but digital health is a relatively new and not always well-understood concept. Our goal was to put together a book that would give business leaders and legal professionals a tool to explain the digital health legal and regulatory landscape, help them understand how this landscape will evolve as digital health solutions change and illustrate how the different digital health solutions play within the broader health care space—both now and in the future.
HHTN:What do digital health leaders and advisors need to know about the rapidly changing digital health care space?
MAZUR:With so many players in the digital health space, including providers, technology developers, IT companies and others, there are a host of legal and regulatory challenges that may come into play. This has created a perfect storm that is driven by outdated, ambiguous and internally inconsistent legal and regulatory frameworks and associated standards as well as increasing scrutiny and enforcement by state and regulatory agencies including, the U.S. Food and Drug Administration, the Federal Trade Commission and others.
So, whether they are a seasoned health industry stakeholder or a newcomer on the scene, a forward-thinking and comprehensive legal and regulatory compliance strategy will be crucial for harnessing the full potential of the digital health ecosystem. But each of the players must also consider the legal and regulatory requirements of the others. After all, they are playing together in the same sandbox, so they must come together in order to develop meaningful and effective digital health solutions—because no one organization can do it alone.
HHTN:What are some of the most important ways technology is impacting the delivery of home health care?
MAZUR:Telehealth is one of the biggest ways because it is the only option that’s focused on health care delivery. No longer an uncommon option for patients, telehealth has evolved to become an important tool for health professionals and has increasingly become the standard of care for home health care delivery. Because telehealth allows providers to virtually engage patients directly in their own homes, it helps make a trip to the doctor feel less episodic, encourages more efficient and effective interactions and helps strengthen the physician/patient relationship. Through telehealth patients have the ability to look beyond their communities for treatment and choose the health care professional that best fits their needs and has the best qualifications and experience for their condition. This may also have the added benefit of helping them identify more cost effective health care services.
We’re also seeing how consumer wellness tools—like wellness trackers or smart watches—are morphing into patient engagement tools that track biometrics or medical conditions and share them with providers.