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Three Tips for Tackling Risk in Digital Health

Digital health companies face a complicated regulatory landscape. While the opportunities for innovation and dynamic partnerships are abundant, so are the potential compliance pitfalls. In 2018 and in 2019, several digital health companies faced intense scrutiny—not only from regulatory agencies, but in some cases from their own investors. While the regulatory framework for digital technology in health care and life sciences will continue to evolve, digital health enterprises can take key steps now to mitigate risk, ensure compliance and position themselves for success. Be accurate about quality. Ensuring that you have a high-quality product or service is only the first step; you should also be exactingly accurate in the way that you speak about your product’s quality or efficacy. Even if a product or service does not require US Food and Drug Administration clearance for making claims, you still may face substantial regulatory risk and liability if the...

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Home Care: The Digital Health Opportunity

A recent article in Kaiser Health News highlights the health risks associated with the increased effort to get patients home—namely, the need for families to gain and effectively deploy the skills needed to care for themselves and family members. The article highlights the risks (and increased rates) of infections, particularly in relation to catheters. However, it does not take much imagination to identify other conditions where at home care is critical. Concise and easy to follow instructions are key, of course, but information technology can play a role here as well. While the business plan for this type of digital health strategy may not be as clear as others, this is the type of sector that could demonstrate the digital health opportunity in the effort to increase value in health care delivery.

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