Congress to Codify FDA Recent Decision Not to Seek Enforcement of Low Risk Mobile Medical Apps

On September 25, the FDA released a guidance document related to Mobile Medical Applications (“MMAs”), which provided critical industry guidance as to which MMAs will be considered medical devices and subject to regulation by the FDA.  On September 30 we reported on these new rules (click here) and on October 23 we also presented a webinar entitled “Mobile Medical Apps: FDA Regulation and Product Liability Implications” which was recorded and is available here.  In particular, the FDA exercised its discretion not to enforce the Federal Food, Drug and Cosmetic Act as it relates to six categories of low risk apps that by definition may be considered MMAs.  These include: (1) help in self-managing disease if there is not a specific treatment recommendation (e.g. apps to maintain good health or track medication schedules); (2) health care information tracking apps (e.g. monitoring weight, arthritis or diabetes); (3) apps that provide easy access to patient treatment (e.g. best practice guidelines); (4) apps to assist patients to communicate health information (video portals); (5) apps that automate simple tasks for physicians (calculating Body Mass Index, Glascow Coma Scale scores, etc.); and (6) apps that enable patients and health care providers to interact with electronic records.

On October 22, 2013, a bipartisan bill was introduced in the House of Representatives entitled “Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013” or “SOFTWARE Act of 2013”.  This proposed amendment to the Federal Food, Drug and Cosmetic Act essentially seeks to codify that certain MMAs are not to be considered “medical devices” for purposes of FDA regulation.  In short, the proposed legislation looks to remove certain types of medical software from FDA regulatory authority.  The legislation draws a distinction between medical software and clinical software.  “Medical software” would continue to be in the FDA’s regulatory purview. However, “clinical software” would not.  The legislation does not specifically talk about mobile medical apps.  It is targeted at what kinds of software FDA has the authority to regulate.

The devil is in the details.  What is “clinical software” and what is “medical software”?  Medical software is defined in two classifications.  One is software intended to “directly” change the structure or function of the body.  The second is software that makes a recommendation for clinical action that include the use of a drug or device “without requiring the involvement of a health care provider”, and would change the structure or function of the body.  Medical software will continue to be FDA regulated under this proposal.

The proposed legislation also defines “clinical software” and “health software”, and specifically states that these newly defined classifications of software shall not be subject to regulation under the Food, Drug and Cosmetic Act.  “Clinical Software” is software is intended to be marketed to health care providers; this is software that analyzes patient data and makes clinical recommendations, but that does not change the structure or function of the body.  “Health software” is a catch-all for software that is not medical software or clinical software that falls into one of three categories.  One, software that “captures, analyzes, changes or presents patient or population clinical data or information.”  Two, software that supports health care, but is not used in the direct delivery of patient care.  Three, software whose primary purpose is to run in the background for use by other software.  

The legislation seeks to provide “the sense of the Congress” that clinical software and health software is good, and that “the President and the Congress should work together to develop and enact legislation that establishes a risk-based regulatory framework for such clinical software and health software that reduces regulatory burdens, promotes patient safety, and fosters innovation.”

As defined in the proposed legislation, it does not seem that clinical software and health software is the type of software that FDA intends to exercise regulatory authority over, based on its recent Guidance for MMAs.  This proposed legislation seems to track the FDA’s decision not to seek enforcement of what is perceived to be its existing regulatory powers related MMAs based upon whether or not the software is specific patient targeted, and intended to the treatment or diagnosis of disease, there may be differences, and who knows what form the definitions will be in when the legislation gets passed into law, if it gets passed into law.  The key is not the platform for the software, but what the software is marketed for.  Clinical software and health software is by definition not for patient specific treatment of disease.  Still, for now, MMA manufacturers, and marketers of other “medical software” must make careful assessments based on the statutory language, the regulations, the intended purpose of the software and/or device and September 25 guidance to ensure that their products are in regulatory compliance.  

We will monitor the status of this proposed bill, and report back with material developments.

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