Regulatory Challenges Facing the mHealth Industry

Foley & Lardner LLP

Innovations in health care technology have created unique challenges for developers and investment companies. Among others, changing FDA guidelines, data security, and reimbursement are all substantial issues facing the rapidly evolving mobile health (mHealth) industry. At the 2014 FOLEYTech Summit, Foley special counsel Monica Chmielewski assembled a panel of industry leaders – Mary Modahl, Chief Marketing Officer of American Weil Corporation; John Morey, Chief Executive Officer and Founder of MyRozi; and Ron Remy, the Chief Executive Officer of Mobile Heartbeat – to discuss the regulatory challenges in this growing mHealth frontier.

Benefits of mHealth

The evolving needs of patients and providers act as drivers of technological innovation in the mHealth sphere. mHealth technologies provide patients with information to deal with diagnoses, platforms to store, share, and manage their health information, and a means to connect with physicians without the time and expense of an in-person visit. Advancements in mHealth also allow providers, hospitals, and health systems to respond to pressures to improve clinical communication, patient experience, and measurable outcomes. Understanding the nuances of the market and an approach that considers the demands of different actors in the system will be a key factor for emerging mHealth companies.

Regulatory Hurdles

The mHealth space has unique regulatory hurdles. For instance, companies in the telemedicine sphere must consider the laws of each state in which they do business, including payment, medical board requirements, and prescription regulations that, in some states, require an initial face to face visit between the patient and provider. mHealth developers must also determine which technologies are subject to FDA oversight. One panelist noted that his company’s strategy was to design its product as though it would be an FDA regulated device. Similarly, mobile technologies raise questions about how HIPAA applies to the collection and storage of personal health data on these platforms. Another significant challenge discussed by the panelists was a method for handling reimbursement, with one panelist avoiding payer reimbursement relationships and the others working with health systems who are integrating mHealth technologies into their provision of care for patients.

Innovations in health care technology bring added accountability and knowledge to the health care supply chain. While each company will face different challenges resulting from their unique products, there is great value in mHealth technologies for both patients and providers.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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