No two health care companies are alike, but many face similar challenges when managing their data risk. Many of these challenges arise due to the competing desires with which every modern organization now struggles—one between innovation and growth on the one hand and compliance and legal risk on the other.

Specifically, the following five issues are top of mind:

  1. The tension between data growth and analytics and data minimization;
  2. Handling connected devices and mobile apps;
  3. Creating effective cross-functional privacy and security teams;
  4. The data implications of acquisitions; and
  5. Effective and tiered vendor management.

We discuss these issues and offer practical guidance on each.

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The fast-growing field of digital health is transforming healthcare by bringing together digital communications technology, electronic health information, electronic prescribing, connected medical devices, and telehealth. These technologies are being deployed by healthcare entities ranging from small health tech startups to large, established hospital systems, medical device companies, and other traditional healthcare companies. Telehealth systems are already in use for applications as varied as direct-to-consumer urgent care and remote provider-to-provider consultations for treatment of complex conditions such as strokes or rare genetic diseases. With these exciting new developments comes a new set of regulatory challenges and concerns for companies in the space. This alert provides a brief overview of some of the laws and regulations that may apply to health companies engaging in digital health.

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  • Opens application process and public comment period for precertification pilot program
  • Nine companies to be chosen by September 1, 2017

Last June, FDA Commissioner Scott Gottlieb made his first public statement as Commissioner by announcing the imminent rollout of a new “Digital Health Innovation Plan.” This statement signaled his intent to prioritize the agency’s efforts to create – and clearly articulate – a regulatory regime that promises to “help innovators navigate a new, modern regulatory process” that will efficiently enable the delivery of safe and effective digital health technologies to patients and consumers.

On July 28, FDA formally rolled out its Digital Health Innovation Action Plan, along with a process for companies to apply to participate in one key component: the Software Precertification Pilot Program. The Action Plan describes several concrete deliverables that the agency plans to complete by the first quarter of 2018 to put a “reimagined” regulatory regime for digital health technologies in place. This will include:

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