The top 5 mHealth regulatory issues for 2013

Editor's Note: This commentary was prepared by Arent Fox, a full-service business law firm with experience working with agencies throughout the federal government. The firm is a strategic affiliate of the 2012 mHealth Summit.

The federal government oversees access to mobile health and other “disruptive innovation” in healthcare products and services. Federal agencies such as the Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services (CMS), Federal Communications Commission (FCC), Federal Trade Commission (FTC) and Patent and Trademark Office (PTO) continue to focus on mHealth initiatives underway at each government office/agency. We expect these mHealth issues to receive substantial attention during the coming year. 

1. The FDA is in the process of finalizing Guidance for Industry on mobile medical applications (MMA) that is intended to establish a pathway for regulating certain MMAs as medical devices.  The FDA issued a Draft Guidance for Industry on MMAs in July 2011, and the industry submitted a large number of comments to the agency in response.  

Essentially, the FDA has proposed that MMAs that are an accessory to a medical device or that “transform” a mobile platform into a medical device be regulated by the agency as medical devices and be subject to the regulatory requirements for medical devices. However, many industry representatives believe the FDA should significantly limit the number of MMAs that would be regulated as devices. Industry leaders also believe the FDA should (a) phase in any new regulatory requirements over the course of several years, and (b) develop small business exemptions to reduce burdens imposed on smaller mobile medical app developers. 

The FDA is expected to continue working with members of the industry in 2013 to issue a balanced Final Guidance to Industry on the regulation of MMAs

In addition, the FDA is continuing its work to develop and implement the Sentinel Initiative, an electronic surveillance system that aggregates multiple health information systems to monitor drug safety. The FDA's goal is to use the system to monitor all FDA-regulated products in the future.

2. CMS published its Final Rules on Sept. 4, 2012, as part of its mHealth initiative to promote the use of electronic health records and health information exchanges to facilitate greater coordination of patient care, reduce medical errors, eliminate duplicate screenings and diagnostic tests and engage patients in their own care. The Final Rules describe requirements that hospitals and healthcare providers must meet in order to qualify for financial incentives during the second stage of the program and criteria that electronic health records must meet to be certified. 

Under the program, doctors, healthcare professionals and hospitals can qualify for Medicare and Medicaid incentive payments if they adopt and “meaningfully use” certified electronic health record (EHR) technology. More than 120,000 eligible healthcare professionals and more than 3,300 hospitals have qualified to participate in the program and receive an incentive payment since it began in January 2011. 

The September 4 Final Rules specifies the criteria that eligible professionals, eligible hospitals and critical access hospitals must meet in order to continue to participate in the Medicare and Medicaid EHR Incentive Programs. Beginning in 2015, providers that cannot demonstrate meaningful use of electronic health record systems will be penalized through reduced Medicare and Medicaid payments for services rendered.   

3. At the FCC, we anticipate that the commission will be focused on implementing and evaluating recommendations made recently by the mHealth Task Force convened by FCC Chairman Julius Genachowski. Specifically, on the policy front, we anticipate that the commission will soon consider new rules to streamline experimental licensing to facilitate the creation of wireless health “test beds” to permit easier testing of mHealth technologies, as well as other rules to reform and modernize the Rural Health Care Program in a manner that will allow networks of hospitals and healthcare facilities to jointly apply for program funds to boost broadband capacity and enable electronic health records. 

We also anticipate that the commission will be active on the international front, working with regulators in other countries to make spectrum available for medical body are networks (MBANs) and to encourage spectrum harmonization to make it easier and safer for patients using mHealth technologies to travel outside the country. The commission has also committed to recruiting a permanent FCC Healthcare Director, who would function as the commission's point of contact to external groups on all mHealth issues. 

4. The FTC has a broad mandate to protect consumers from unfair or deceptive acts or practices as well as false or misleading claims, and we anticipate that it will continue to be active in examining claims made by mHealth companies. The FTC also has jurisdiction for health data breaches when the entities involved are not HIPAA-covered entities, which could be important to many mHealth app makers. The FTC has already been active in the space, taking enforcement action against several mobile health app marketers, including one that claimed to treat acne through a light emitted from the device. In fulfilling its role, the FTC collaborates closely with both the FDA and FCC on areas where there is jurisdictional overlap.

5. At the PTO, mHealth companies continue to pursue patent protection for inventions relating to mHealth, which may be valuable, for example, in protecting software and other innovations and for use in attracting investment.

In addition to mHealth companies pursuing patent protection, non-practicing patent entities, also often referred to as “patent trolls,” appear to be increasing their acquisition of patent portfolios in technologies relating to mHealth. As patent trolls acquire larger patent portfolios relating to mHealth, we anticipate mHealth companies becoming subject to increased licensing demands and the associated costs for defending patent threats. The new America Invents Act (AIA) includes provisions that mHealth companies may use to help prevent and, if necessary, defend an attack by patent trolls. For example, provisions of the AIA provide mechanisms that mHealth companies may use to prevent overly broad patents filed by patent trolls from issuing. The AIA also makes it easier for mHealth companies to challenge whether a patent asserted by patent trolls is valid. In addition, the AIA may make it more difficult for patent trolls to bring a single lawsuit against a group of companies.

In short, while provisions of the AIA may not completely prevent patent trolls from bringing a lawsuit against mHealth companies, the AIA provides additional tools that mHealth companies may use in preventing and, if necessary, defending lawsuits brought by patent trolls.

This article was authored jointly by attorneys from relevant regulatory practices at Arent Fox, including Jamie Ravitz and James Hartten, Food and Drug; Wib Chesser, Intellectual Property; and David Carter, Communications, Technology & Mobile.