Join us on November 8, 2018, for the third installment of McDermott’s live webinar series on digital health. In this installment, partners Bernadette M. Broccolo, Jiayan Chen and Vernessa T. Pollard will explore opportunities for accelerating biomedical research, development and commercialization through digital health tools and solutions, such as end-user license agreements (EULAs), wearables and mobile apps, telemedicine, and big data exchange and analytics. They will discuss tactics for overcoming challenges related to these new approaches, as well as evolving compliance issues, including:

  • Privacy and security
  • Human subject protection
  • The US Food and Drug Administration pre-market approval regime

They will also review alternative compliance and contracting strategies for managing risk while capturing opportunity from the perspective of key stakeholders, such as sponsors, investigators, research sites and digital health developers.

Click here to register for this event.

The digitization of health care and the proliferation of electronic medical records is happening rapidly, generating large quantities of data with potential to provide valuable insights into disease and wellness and help solve challenging public health problems.

There is tremendous enthusiasm over the possibilities of leveraging this data for secondary use–i.e., a use of data that is distinct from the purpose for which it was originally collected. However, such secondary use is often subject to intersecting legal and regulatory regimes–including HIPAA, the Common Rule, and the Federal Food, Drug, and Cosmetic Act and its implementing regulations–that are not fully harmonized.  This lack of harmonization in requirements, coupled with the wide range of industry players involved–including regulators, academic medical centers, health systems, payers, technology companies, manufacturers and industry entities, research institutions, registries, and professional societies, to name a few– presents challenges that require careful planning and implementation. While regulators have recently taken significant steps to reconcile the differences among these laws and provide a path forward for harnessing the potential of big data, some specific requirements within these individual regulations continue to present challenges.

It is critical for academic medical centers and teaching hospitals, which stand at the intersection of government-funded research and industry-sponsored research, and are also paving the way in partnerships with non-traditional health care players—to understand the evolving legal framework and business and compliance imperatives behind the quest for digital health information.

During the AHLA Annual Meeting on Tuesday, June 26, McDermott partner Jiayan Chen will review trends and the value proposition relating to secondary use, with a particular focus on challenges presented by secondary use in the precision medicine and digital health context.  Along with co-presenter Leah Voigt, she will explore key regulatory and sub-regulatory developments relating to the secondary use of data under FDA regulations, the Common Rule, and HIPAA, and will also use case studies to explore, in a practical context, the challenges and ambiguities that remain when pursuing internal secondary use initiatives and external collaborations, including implementation and contracting tips, insights, and strategies.

Recycle, Recycle, Recycle: Key Considerations for Research, Medical Education, and Other Secondary Uses of Data
AHLA Annual Meeting, Chicago, IL | June 26, 2018 | 9:45 – 10:45 am | Registration and program details.

McDermott’s Cocktail Reception during the AHLA Annual Meeting
The Art Institute of Chicago | June 26, 2018 | 6:00 – 8:00 pm
Following the programming on Tuesday, we invite you to join us for our annual cocktail reception at The Art Institute of Chicago. We look forward to an evening of networking, cocktails and private gallery tours with our colleagues, friends and fellow AHLA members. RSVP today!

Throughout 2017, the health care and life sciences industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and payment as well as product research, development and commercialization for both long-standing and new stakeholders. At the same time, lawmakers and regulators made meaningful progress toward modernizing the existing legal framework in a way that will both adequately protect patients and consumers and support and encourage continued innovation, but their efforts have not kept pace with what has become the light speed of innovation. As a result, some obstacles, misalignment and ambiguity remain.

We are pleased to bring you this review of key developments that shaped digital health in 2017, along with planning considerations and predictions for the digital health frontier in the year ahead.

Read the full Special Report.

Last Tuesday afternoon, the US Food and Drug Administration (FDA) held a webinar to outline a recently-published Digital Health Innovation Action Plan (Plan). In the Plan, the agency recognized that the traditional regulatory approach toward moderate and high risk medical devices is not well suited for the fast-paced, iterative design, development and type of validation used for digital health software products today. Going forward, the agency plans to explore an innovative approach to regulating these types of products. The approach contains three primary prongs: (1) the issuance of new guidance, (2) the Digital Health Software Precertification Program and (3) an internal expansion of FDA’s digital health capabilities.

The webinar was presented by Bakul Patel, Associate Director for Digital Health at FDA. At least 905 attendees logged in to the webinar. Continue Reading FDA Outlines the New Digital Health Innovation Action Plan and Software Precertification Pilot Program

On March 23, 2017, the New York Attorney General’s office announced that it has settled with the developers of three mobile health (mHealth) applications (apps) for, among other things, alleged misleading commercial claims. This settlement highlights for mHealth app developers the importance of systematically gathering sufficient evidence to support their commercial claims.

Read the full article.

On July 29, 2016, the US Food and Drug Administration (FDA) finalized General Wellness: Policy for Low Risk Devices Guidance (Final Guidance) detailing its risk-based regulatory approach to relax certain regulatory requirements for low risk products that promote a healthy lifestyle—coined “general wellness products.” In the Final Guidance, the FDA makes minimal substantive changes to the policies articulated in its January 2015 draft guidance. Notably, however, the Final Guidance added and refined several examples to illustrate the products that are subject to FDA’s enforcement discretion and ultimately outside FDA’s intended scope of regulatory oversight.

Read the full article, FDA Finalizes Guidance on Low Risk General Wellness Devices here.

This week, the Federal Trade Commission (FTC or Commission) released an interactive tool (entitled the “Mobile Health Apps Interactive Tool”) that is intended to help developers identify the federal law(s) that apply to apps that collect, create and share consumer information, including health information. The interactive series of questions and answers augments and cross-references existing guidance from the US Department of Health and Human Service (HHS) that helps individuals and entities—including app developers—understand when the Health Insurance Portability and Accountability Act (HIPAA) and its rules may apply.  The tool is also intended to help developers determine whether their app is subject to regulation as a medical device by the FDA, or subject to certain requirements under the Federal Trade Commission Act (FTC Act) or the FTC’s Health Breach Notification Rule. The Commission developed the tool in conjunction with HHS, FDA and the Office of the National Coordinator for Health Information Technology (ONC).

Based on the user’s response to ten questions, the tool helps developers determine if HIPAA, the Federal Food, Drug, and Cosmetic Act (FDCA), FTC Act and/or the FTC’s Health Breach Notification Rule apply to their app(s). Where appropriate based on the developer’s response to a particular question, the tool provides a short synopsis of the potentially applicable law and links to additional information from the appropriate federal government regulator.

The first four questions cover a developer’s potential obligations under HIPAA. The first question explores whether an app creates, receives, maintains or transmits individually identifiable health information, such as an IP address. Developers may use the tool’s second, third and fourth questions to assess whether they are a covered entity or a business associate under HIPAA. The tool’s fifth, sixth and seventh questions help developers establish whether their app may be a medical device that the FDA has chosen to regulate.  The final three questions are intended to help users assess the extent to which the developer is subject to regulation by the FTC.

Although the tool provides helpful, straightforward guidance, users will likely need a working knowledge of relevant regulatory principles to successfully use the tool.  For example, the tool asks the user to identify whether the app is “intended for use” for diagnosis, cure, mitigation, treatment or disease prevention, but does not provide any information regarding the types of evidence that the FDA would consider to identify a product’s intended use or the intended use of a mobile app (e.g., statements made by the developer in advertising or oral or written statements). In addition, how specifically an app will be offered to individuals to be used in coordination with their physicians can be dispositive of the HIPAA analysis in ways that are not necessarily intuitive.

The tool provides a starting point for developers to raise their awareness of potential compliance obligations. It also highlights the need to further explore the three federal laws, implementing rules and their exceptions. Developers must be aware of the tool’s limitations—it does not address state laws and is not intended to provide legal advice. In fact, the tool does not provide links to the actual text of the laws or regulations and is clearly aimed at non-lawyers.  Nor does the tool highlight all applicable guidance documents provided on the websites for each federal regulator, which shed additional light on what that regulator has determined is within or outside of its oversight.