Affidavit: Healthcare and the Law - Innovation and Modernization: Reshaping FDA Regulation of Digital Health Solutions

Contributors: Lisa W. Clark, JD’89 and Samantha Dalmass 
To learn more about Lisa and Samantha, click here. 


1242.jpgOver the last several years, digital health technology has transformed the healthcare sector through the proliferation of medical software, mobile medical applications, medical device data systems, medical image storing devices, medical image communication devices and other digital health devices and systems. While global technology leaders and industry stakeholders have been quick to jump on the digital health bandwagon, the Federal Food and Drug Administration (“FDA”) has proceeded deliberately. However, over the last year the FDA has picked up the pace significantly, making digital health a priority and modifying the traditional regulatory processes for approving medical software. Developers, investors, and other stakeholders should follow these developments carefully. 

Traditionally, medical software has been subject to the same regulatory oversight as hardware medical devices. Recognizing that many digital health solutions pose no or very minimal risk to the consumer, in December, 2016, the 21st Century Cures Act (the “Act”) amended the definition of a “medical device” to exclude medical software that supports administrative functions, e.g., billing and appointment scheduling, and inventory management or workflow, encourages a healthy lifestyle, serves as an electronic patient record; assists in displaying or storing data; or provides limited clinical decision support. This is welcome news for those who are developing, investing in, selling, or marketing these kinds of products. 

The Act also authorizes the FDA to update its regulations and guidance applicable to digital health devices to conform to the Act. In August 2017, the FDA released its Digital Health Innovation Action Plan that describes its new approach to the regulation of medical software and digital health devices and outlines its efforts to encourage digital health innovation by 1) issuing key guidance to clarify certain provisions of the Act; 2) launching a pilot pre-certification program, the FDA Precertification (Pre-Cert) for Software Pilot Program; and 3) building its bench strength and expertise through the Center for Devices and Radiological Health (CDRH). 

The redefined approach will replace the product-by-product premarket review process that software manufacturers undergo when seeking FDA approval for devices. 

Under the traditional system, mobile health apps and medical software were required to undergo the lengthy FDA process of scientific and regulatory review to ensure device safety and effectiveness before going to market. The type of premarket application a developer or manufacturer submits to the FDA depends on classification of the device. Classification depends on the intended use of the device as well as the risk the device poses to the user of the device. Class I includes those devices with the lowest risk, and Class III includes those with the greatest risk. Generally, devices with greater risk are subject to lengthier and more administratively burdensome approval procedures before they may proceed to market. There is also a de novo classification category for novel products. 

The FDA’s new approach will allow software developers who meet key metrics and performance indicators to avoid the traditional, classification-based review approach. Once pre-certified, software developers will be able to market their low-risk devices without having to deal with additional FDA review. Ideally, by streamlining the review process and allowing developers to market low-risk devices without requiring additional pre-market information, this program will enable a faster and more efficient regulatory approval pathway that is better suited for the faster iterative design, development, and type of validation used for medical software. 

The Plan also provided for the Pre-Cert Pilot Program, which is designed to assist the FDA in developing a final Pre-Cert Program by analyzing the processes and measures used by select software developers to develop, test, and maintain their products. In September 2017, the FDA chose nine software developers of varying size and complexity to participate in the Pilot Program, including Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool, and Verily. The participants agreed to provide to the FDA access to the quality measures they currently use with respect to their products, including those that are in development as well as those on the market, and other internal information. The FDA will consider this information in determining which key metrics, performance measures, and other objective criteria software developers must meet in order to qualify for participation in the final Pre-Cert Program. 

On January 30-31, 2018, four months after launching the Pilot Program, the FDA convened an important two-day public workshop entitled “Fostering Digital Health Innovation: Developing the Software Precertification Program” to discuss the progress of the Pilot Program and to ask for public input on the design and ongoing development of the final Pre-Cert Program. Panelists from companies participating in the Pilot Program and other industry stakeholders shared their experiences and perspectives regarding the FDA’s new approach to digital health. The FDA indicated it plans to have a Version 0.1 of the Pre- Cert Program ready to launch by the end of 2018. The initial model will have three key components: (1) precertification, (2) streamlined market review, and (3) access to post-market data. The FDA is currently working on the first component and will reassess current statutory and regulatory guidelines after it establishes the elements necessary for the precertification program. In the meantime, the FDA is accepting public comment on development of the precertification program until June 29, 2018. 

The FDA’s commitment to redesigning its regulatory approach to digital health is timely for stakeholders who have struggled to understand the government’s oversight strategy. Armed with this new information, a developer may have an easier time obtaining funding, and the investor will be better able to assess the risk of a product’s success or failure and opportunities for reimbursement. This is all good news for the digital health industry. 

Contact Lisa at: [email protected] 

Contact Samantha at: Law Clerk
Duane Morris LLP
30 South 17th Street Philadelphia, PA 19103-4196
Phone: 215.979.1257
Email: [email protected] 



Disclaimer: This article is prepared and published for informational purposes only and should not be construed as legal advice. The views expressed in this article are those of the author and do not necessarily reflect the views of the author’s law firm or its individual partners.