On October 22, Rep. Marsha Blackburn (R-TN) introduced a bill serving to “provide for regulating medical software, and for other purposes” in the House of Representatives.  The bill, entitled the Sensible Oversight for Technology which Advances Regulatory Efficiency (“SOFTWARE”) Act (“the bill”), was co-sponsored by a bi-partisan group of lawmakers.

The bill creates a regulatory scheme based on three newly defined categories of software—“medical software,” “clinical software,” and “health software.”  Although the bill proposes to carve out “medical software” from the definition of “device” in Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 321) (“the Act”), medical software would be subject to the same regulatory requirements as medical devices under the Act.  In contrast, “clinical software” and “health software” would not be subject to regulation under the Act.

The bill defines medical software as software intended for human or animal use that is intended to be marketed (1) “to directly change the structure or any function of the body of man or other animals;” or (2) for “use by consumers and makes recommendations for clinical action that (i) includes the use of a drug, device, or procedure to cure or treat a disease or other condition without requiring the involvement of a health care provider; and (ii) if followed, would change the structure or any function of the body of man or other animals. . . .”  Medical software does not include software “whose primary purpose is integral to the functioning of a drug or device” or software that is a “component of a device;” such software presumably would continue to be regulated as part of the “parent” device or drug product.
Continue Reading House to Consider Bill Excluding Clinical and Health Software from Regulation as Medical Devices

FDA’s regulation of Health IT under its medical device authorities can be seen as proceeding on two separate tracks during the last year.

Track one is FDA’s ongoing policymaking.  In 2011, FDA issued a draft guidance document on mobile medical applications and a final rule on medical device data systems, setting forth an approach for regulating products within these Health IT categories.  FDA has stated that it intends to finalize the mobile medical apps draft guidance by the end of this fiscal year, and the agency has indicated that it intends to develop guidance regarding its regulation of clinical decision support software.

Track two is an assignment from Congress.  Section 618 of the Food and Drug Administration Safety and Innovation Act (FDASIA) directed FDA to issue a report to Congress by January of 2014 setting forth a “risk-based regulatory framework pertaining to health information technology, including mobile medical applications.” Section 618 also directed FDA to create a diverse working group of Health IT experts to assist it in this task.  That group held its final meeting last month, discussing a set of draft recommendations for regulation of Health IT.  The group will provide a final set of recommendations to FDA in September.  FDA will review the recommendations, along with public comments, when drafting its report to Congress.
Continue Reading FDASIA Workgroup Releases Draft Recommendations for Regulation of Health IT

As our colleagues discussed in a previous post on InsideMedicalDevices, FDA took its first publicly announced enforcement action against a mobile app developer on May 22, issuing an “It Has Come to Our Attention Letter” to India-based app developer, Biosense Technologies.  The letter received extensive media coverage, and the mHealth sector was immediately abuzz with interest (and concern) about its implications.

Commentators observed that the letter appeared to be intended, in large part, as an educational tool for industry.  As such, it’s appropriate to ask:  what lessons should industry draw?  Although single enforcement actions do not always serve as reliable predictors of future actions, the letter offers a handful of key takeaways:
Continue Reading Lessons from FDA’s First Public Mobile Medical Apps Enforcement Letter

As was reported previously on our sister blog, InsideMedicalDevices, the regulation of mobile medical apps continues to be an issue on Congress’ radar.  Last week, the Republican-led House of Representatives Energy and Commerce Committee held three days of hearings addressing how FDA regulation and the medical device tax could affect innovation in mobile applications and devices, how technological advancements benefit patients, ways to ensure that innovation continues, and the Obama Administration’s perspective and future plans with regard to regulation of medical apps.

Christy Foreman, Director of CDRH’s Office of Device Evaluation, spoke on behalf of FDA.  She defended as a “narrowly tailored approach” the FDA’s proposed policy toward regulating mobile medical apps announced in the 2011 Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications.  (We discussed the draft guidance in a client alert and a recent article.)  Ms. Foreman also stated that the final version of this guidance is in the final stages of internal review and is expected to be issued before the end of fiscal year 2013.  The final guidance will address commenters’ requests for clarification and provide additional examples of regulated apps.  Ms. Foreman also deflected questions relating to the medical device tax, stating that taxes are not within FDA’s jurisdiction.
Continue Reading FDA Tells Congress to Expect Final Guidance on Mobile Medical Apps This Year