Companies looking to enter the digital health field face myriad legal implications unique to doing business in this sector. Whether emerging or established, companies exploring health care opportunities benefit from careful planning around complex issues such as pace of development, reimbursement systems, strategies for responsible data collection and use, and effective corporate compliance programs. In this podcast, McDermott partners Sarah Hogan, Lisa Schmitz Mazur and Dale Van Demark take a closer look at these and other important factors companies should review when contemplating a move into the digital health ecosystem.

Q. What issues should companies consider before they enter today’s digital health care market?

DV: The first and perhaps most important thing to focus on is the business plan. A lot of business plans that may work in other service sectors may not work in the health care industry because of the way that it is structured or because of consumer expectations.

Beyond that, there are real cultural differences that we see technology companies come up against when they enter into the health care market. Frequently, technology companies are used to a very fast pace. They are used to making mistakes and learning from them, and evolving and developing to move forward. The health care industry has traditionally been much slower and more deliberative, with the goal of getting it right the first time being predominant. That cultural difference can cause problems in building relationships and setting expectations for both pace and service levels.

Finally, understanding the complexity of health care infrastructure is very important. Understanding how the health care system works and how your product, service and business plan work within that ecosystem is critical to establishing the relationships you want and really selling into that marketplace. Continue Reading Breaking into Digital Health: Factors Companies Must Consider

Both developers and users of digital health solutions face both immense opportunities and daunting challenges. One key challenge is compliance with the often complex state and federal laws and regulations adopted by the numerous regulatory bodies responsible for overseeing different aspects of digital health. The following illustration identifies the numerous regulatory bodies that have been increasingly focused on the use of technology in healthcare and are expected to continue their focus and enforcement activities in the coming years.

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Because innovation is moving faster than the law in this area, in-house counsel and compliance officers must be prepared to identify and manage the myriad compliance and liability risk considerations arising from participation in and use of digital health tools. This will require an understanding of how each of these regulatory bodies oversees and regulates digital health today and close monitoring of how that evolves and changes in the future.

Health care providers, patients and consumers should approach the selection and use of digital health advancements with a reasonable degree of caution. As AMA CEO James L. Madara, MD, advised in his address at the recently concluded 2016 AMA Annual Meeting, “…. Appearing in disguise among these positive products are other digital so-called advancements that do not have an appropriate evidence base … or that just do not work well or that actually impede care, confuse patients and waste our time … from ineffective electronic health records to an explosion of direct-to-consumer digital health products to apps, some of which are of poor quality.” In this regard, providers would be well served by performing sufficient “due diligence” to determine whether the functionality of the digital health tool effectively meets their specific clinical and operational needs, as well as the needs of their patients, and to evaluate the developer’s compliance with applicable laws and regulations.