What FDA’s Digital Health Innovation Plan Means for Digital Diagnostics

Which categories of digital health products will be subject to which actions within the CDRH's Digital Health Innovation Action Plan? Experts dissect the latest developments.

Nancy Stade, Allison Fulton, and Zimu Yang 

FDA Commissioner Scott Gottlieb’s recent blog posts in the FDAVoice about FDA’s Digital Health Innovation Plan have sketched out multiple different actions that cover a diverse group of digital health products. This group ranges from fitness trackers that provide biometric information to clinical decision support (CDS) software to software that uses advanced algorithms to provide diagnoses based on patients’ specimens and images.

While a single, unifying theme underlies the different actions described in the blog posts—namely, to increase clarity and reduce regulatory burden for digital health devices—the particulars of the different actions may vary significantly, ranging from complete exemption from FDA regulation to continued premarket review with a lightened evidentiary burden. An important open question for manufacturers of digital health products is which categories of digital health products will be subject to which actions within the Digital Health Innovation Plan.

This article will address this question by surveying key developments in FDA’s oversight of digital health products in recent years, focusing on FDA’s regulatory approach to products that provide biometric or diagnostic information. The article will then identify categories of products where uncertainty remains concerning the current regulatory policy.  Concerning products in the latter category, the article will lay out a tiered approach to oversight. This tiered approach could lay the groundwork for FDA, industry, and other stakeholders to develop a regulatory framework for digital health products that reduces uncertainty and maintains an appropriately scaled level of oversight.

I. Developments in FDA's Oversight of Digital Health Products

The Digital Health Innovation Plan builds on a series of actions taken by FDA’s Center for Devices and Radiological Health (CDRH) over the past several years to define its approach to digital health products, starting with the 2013 publication of the guidance document, Mobile Medical Applications (MMA). That guidance defined a limited subset of mobile apps as “mobile medical apps” that would be subject to regulation as medical devices.

A “mobile medical app” is a mobile app that meets the definition of device in the Federal Food, Drug, and Cosmetic Act (FDCA)[1] and either is intended to be used as an accessory to a regulated medical device or to transform a mobile platform into a regulated medical device. Importantly, the guidance articulates the policy that FDA exercises its regulatory oversight based on functionality rather than platform, meaning that the regulatory approach in the guidance applies not only to mobile apps with health-related functionality, but to digital health products generally.[2]   

FDA further defined its approach to digital health in April 2014, when the agency, as part of a task force comprised of FDA, the Federal Communications Commission (FCC), and the Office of the National Coordinator for Health Information Technology (ONC), issued the preliminary FDASIA Health IT Report. The Food and Drug Administration Safety and Innovation Act (FDASIA) directed the three agencies to develop “a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology.”  The resulting report is noteworthy for providing FDA’s most substantive policy discussion to date concerning CDS software, a category of software FDA has struggled to define and regulate. CDRH expressly excluded CDS from the MMA guidance, stating CDRH would describe its policy on CDS in separate guidance,  and in its Digital Health Action Plan announced that a guidance further defining categories of exempt CDS will be issued in the first quarter of 2018.

Currently, however, statements in the FDASIA Health IT report are FDA’s clearest signal on the agency’s oversight approach to CDS. The FDASIA Health IT Report provides a working definition of CDS as software that “provides health care providers and patients with knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and health care.” Noting that CDS risks are generally low compared to the potential benefits, the report identifies a number of health management CDS functionalities as exempt from FDA oversight, including: drug dosing calculations, drug formulary guidelines, and evidence-based clinician order sets tailored for a particular condition, disease, or clinician preference. On the other hand, the report notes that for a “small subset of CDS software that are medical device[s], present higher risks, and generally have been subject to active oversight by FDA… active oversight should be continued.” This subset includes computer aided detection/diagnostic software, radiation treatment planning, and robotic surgical planning and control devices.

In its guidance document, General Wellness: Policy for Low Risk Devices (Wellness Guidance), issued on July 29, 2016, CDRH identified an additional category of digital health products that it would not regulate. Under the guidance, general wellness products are products intended for use in (1) maintaining or encouraging a general state of health or a healthy activity, or (2) in promoting a healthy lifestyle to help reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition; such products include low risk digital health products that monitor, record, and generate biometric information for users, including pulse rate, sleep trends, daily energy expenditure, cardiovascular activities, and food consumption. 

The guidance limits the category of general wellness products, however, in that it excludes products that “involve an intervention or technology that may pose a risk to the safety of users and other persons if specific regulatory controls are not applied.” The scope of this exclusion is unclear, but the language could mean that FDA does not necessarily consider currently regulated low risk digital health products intended to be general wellness products, even when intended only for general wellness purposes.

Other activities taken by CDRH in recent years, though not focused on digital health, have provided additional data points concerning FDA’s policy toward diagnostic digital health devices. For example, in its efforts to develop a framework for oversight of laboratory developed tests (LDT), FDA has repeatedly signaled a heightened regulatory concern with black box algorithms, or diagnostic software that incorporates sophisticated nontransparent algorithms to support—or supplant—manual interpretation of IVD tests.[3] In addition, FDA as a participant in the International Medical Device Regulators Forum (IMDRF) published the software as a medical device (SaMD) guidance. Although the guidance does not refer to CDS, the guidance provides a framework for assessing the risks of—and level of evidence necessary to validate—SaMD that aligns with FDA’s general approach to CDS. Under the proposed framework, software that provides information to inform clinical management presents the lowest level of risk; software that drives clinical management, for example, by supporting diagnoses, presents a moderate risk; and software that provides diagnoses presents the highest level of risk. Under the guidance, transparency of the algorithm is also a factor in assessing the risks presented by SaMD.

II. Current Lay of the Land

FDA’s actions have resulted in clarity at the poles of the regulatory spectrum of diagnostic digital health products. At one end are low risk products that provide health-related information but do not purport to diagnose a disease or condition and that have not been historically regulated. For example, the Wellness Guidance exempts “low-risk general wellness products,” which includes wearable fitness trackers that monitor heart rates and pulse oximeters used recreationally. Similarly, to clarify how the Mobile Medical Apps guidance applies to different products, FDA maintains a long list of apps exempted from FDA oversight. 

On the other end of the spectrum are diagnostics that may be relied on to decide treatment for serious conditions. For example, the Mobile Medical Apps guidance identifies Picture Archiving and Communication Systems (PACS) and Computer Aided Detection (CAD) image processing software as types of functionality FDA will continue to oversee, and FDA has repeatedly indicated its concern with nontransparent diagnostic algorithms, even if the agency has been unable to assert oversight over such functionality in the LDT context. 

Nonetheless, considerable uncertainty remains, uncertainty that has not been fully resolved by recent legislation. Enacted on December 13, 2016, Section 3060 of the 21st Century Cures Act exempts several categories of medical software functions from FDA device regulation, but leaves unanswered questions about the scope of the exclusions from oversight for wellness products and CDS. For example, the legislation carves out from the definition of device software products “for maintaining and encouraging a healthy lifestyle;” this language codifies FDA’s Wellness Guidance for software, but does not further define the scope of the wellness category.

Concerning CDS, the legislation also excludes from the definition of a device software that, among other things, “supports or provides recommendations to a healthcare professional about prevention, diagnosis, prevention, or treatment of a disease or condition” if the software permits the HCP to “independently review” the basis for the recommendations, and provided the software is not “intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal acquisition system.” Thus, the legislation seems to retain FDA’s concern that complex algorithms used to interpret radiological images and in vitro diagnostic test information warrant continued FDA oversight.

III. Potential Approach for Products That Provide Biometric and/or Diagnostic Information

The latest developments in FDA’s digital health policy, the Digital Health Innovation Plan, branded by CDRH as the Digital Health Innovation Action Plan, provide an opportunity for FDA to work with its stakeholders to address remaining areas of uncertainty. One component of the plan will be guidance clarifying how the software provisions of 21st Century Cures affect FDA’s existing digital health policies. FDA has signaled that it will use this guidance to exclude additional categories of digital health products from oversight, stating that the guidance will address additional technologies that, though not addressed by 21st Century Cures, present low enough risks that FDA does not intend to subject them to certain premarket regulatory requirements. FDA also has announced a forthcoming guidance on CDS software that will delineate CDS software that is no longer under FDA’s jurisdiction.   

Another major component of the initiative is reliance on pre-certification of digital health manufacturers “who demonstrate a culture of quality and organizational excellence based on objective criteria, for example, that they can and do excel in software design, development, and validation (testing),” to relieve lower risk digital health devices from premarket review. Manufacturers of higher risk digital health devices may be subject to a reduced premarket burden through participation in the precertification program and reliance on real world evidence—or evidence from sources outside of traditional clinical trials, such as observational studies of device performance in clinical use.

Taken together, the various components of the Digital Health Innovation Plan suggest the framework for an overarching approach to digital health products that provide biometric or diagnostic information. First, the proposed guidance is an opportunity for FDA to draw a bright line defining general wellness products to include all low risk products intended only for general wellness purposes, regardless of whether the functionality is currently regulated by FDA. In particular, the guidance could specify that digital health products that provide basic biometric information (e.g., blood pressure, arrhythmia, hydration level) and are marketed as fitness trackers, with no diagnostic claims would not be regulated as devices. 

Second, through guidance and implementation of the proposed precertification program, CDRH could exempt from premarket review products that provide biometric/diagnostic information and are marketed with diagnostic or other medical claims, relying on the proposed precertification program to ensure quality in the manufacture and design of these products. FDA in fact already relies on third parties to review Quality Systems as part of its Medical Device Single Audit Program, and the approach reflects recommendations in the FDASIA Health IT Report from stakeholder agencies (FDA, ONC, FCC) to employ industry-led standards and certifications in the oversight of health IT products. 

Lastly, while FDA has signaled its intention to retain premarket oversight over sophisticated, non-transparent algorithms used in diagnosis of diseases or pharmacogenomics, the digital health pilot presents an opportunity to articulate an approach to such products that minimizes premarket burden by appropriately focusing on quality design and real-world data collection. Real-world evidence is data generated outside of a traditional clinical trial, which can be resource-intensive and present a barrier to some digital innovators. Real-world evidence also often reflects how a product will perform in a broader, more representative population than in a traditional clinical trial.

In the context of algorithms that are available on smart phones (via mobile apps), reliance on real-world evidence represents a unique opportunity to potentially collect a large amount of data in a short amount of time, thus decreasing study time and ultimately time to market. For digital diagnostic devices, such data could be gathered under an investigational device exemption (IDE) under 21 CFR 812.2(c)(3),[4] allowing use of the device in clinical settings to generate real-world evidence that can then support a 510(k) or de novo submission. 

IV. Conclusion

The new Digital Health Innovation Action Plan provides opportunities for robust interaction between FDA and the agency’s stakeholders about the appropriate level of oversight for digital health products, including commentary on guidances and participation in the precertification pilot program. A successful outcome will result in (1) greater regulatory clarity for digital health products that should not be regulated as devices; (2) appropriate balance between premarket and other controls for digital health products that are devices; and (3) increased FDA acceptance of real-world data to support regulatory decision-making. Stakeholders willing to engage FDA proactively can help to shape a comprehensive and coherent digital health policy.  

Nancy Stade, JD is a partner in the food, drug, and medical device regulatory practice at Sidley Austin LLP in Washington, DC.

Allison Fulton, JD is a partner in food, drug, and medical device regulatory, compliance, and enforcement practice at Sidley Austin LLP in Washington, DC.

Zimu Yang, JD is an associate in food, drug, and medical device regulatory, compliance, and enforcement practice as well as white collar government litigation and investigations practice at Sidley Austin LLP in Washington, DC.


[1] Section 201(h) of the FDCA defines a device as “…an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory”, that is “… intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man …” or “… intended to affect the structure or any function of the body of man or other animals ….”  21 U.S.C. § 321(h).

[2]  Medical intended use remains a threshold criterion for FDA’s oversight; functionality may then determine whether FDA exercises that oversight.

[3] See FDA, Draft Guidance, In Vitro Diagnostic Multivariate Index Assays (Jul. 26, 2007); FDA, Draft Guidance, Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (Oct. 3, 2014) (FDA announced that it would not finalize the Draft Guidance in Nov. 2016); FDA, Discussion Paper on Laboratory Developed Tests (LDTs) (Jan. 13, 2017); FDA, Draft Guidance, Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases (July 8, 2016).

[4]  “[21 CFR Part 812 (IDE)] does not apply to investigations of… [a] diagnostic device… if the testing: (i) [i]s noninvasive, (ii) [d]oes not require an invasive sampling procedure that presents significant risk, (iii) [d]oes not by design or intention introduce energy into a subject, and (iv) [i]s not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure.”  21 CFR 812.2(c)(3).


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