Regulatory Challenges Facing the mHealth Industry

03 February 2015 Innovative Technology Insights Blog

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.

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.