More than 60 percent of Americans already use mobile apps to make informed choices about their health. In the year ahead, we expect app-enabled telehealth tools and remotely monitored patient-generated health data (PGHD) to present more promising avenues to improve care quality, reduce hospitalizations, avoid medical complications, and improve patient satisfaction, particularly for the chronically ill.

As the sole regulator of medical devices, the Food and Drug Administration (FDA) plays a vital role for connected health innovations to get into the hands of doctors, caregivers, and patients. The Connected Health Initiative (CHI) has long worked with the FDA to shape policies and regulations that support and foster medical innovations, while protecting patient safety.

In 2017, the FDA introduced new guidance and programs that will greatly influence our members’ ability to introduce new telehealth tools to market and into the doctor’s office. We will use the momentum of these new changes and regulatory advancements to continue our advocacy with the FDA in 2018.

New Draft Guidance for Clinical Decision Support Software

For years, CHI members have developed clinical decision support (CDS) tools that help doctors use data to make treatment decisions. However, silence from the FDA on whether, and how, it regulates CDS software ultimately dampened the drive to bring these care-improving, cost-saving innovations to the medical community. In fact, several of our members recalled or redesigned effective products because of the uncertainty surrounding the FDA’s regulatory approach to CDS.

The 21st Century Cures (21CC) Act includes a requirement that the FDA issue CDS software guidance—a provision that CHI recommended. Following the passage of the 21CC Act, the FDA finally released draft regulatory guidance on CDS software.

The draft guidance clarifies the necessary functions of CDS software to be considered a “device,” as amended by the 21CC Act. The guidance states that CDS software is considered a regulated medical device if it makes clinical diagnoses or treatment decisions independent of the doctor. Conversely, CDS software is not considered a regulated medical device if it enables a doctor or healthcare professional to make recommendations or independent review decisions. In other words, the FDA sees CDS software as a tool to assist physicians and their ability to make treatment decisions; if the software makes autonomous decisions, it will be regulated.

In addition to this definition, the FDA’s draft guidance offers examples to illustrate its regulatory approach to CDS software. The examples confirm that software making recommendations by combining patient-specific information with widely-available medical practice guidelines, public drug labeling information, or publicly-available information will not be regulated as medical devices. Conversely, software that independently analyzes or manipulates data, like “proprietary algorithms,” to recommend a specific treatment, without prompting the healthcare professional to review the decision, will be classified as medical devices. It is important to note that the FDA guidance reinforces the policy of enforcement discretion (i.e., absolving the need for regulation) for software that is considered a medical device but poses a low risk to patients.

The draft guidance also introduced a new category, Patient Decision Support (PDS) software, which pertains to software used by anyone not classified as a healthcare professional (such as a patient or other caregiver). This definition leaves PDS software unaffected by the 21CC Act’s section 520(o). The FDA’s approach to PDS software aligns with CDS software and uses the same “independent review of the basis of the recommendation” differentiation. The guidance also offers), offering an enforcement discretion policy for PDS software equivalent to that taken for CDS software excluded from the definition of a medical device as well as that taken for CDS that qualifies as a medical device but would enjoy enforcement discretion. Examples of PDS software that will see future FDA regulatory oversight, as well as software that will not, are included.

Public comment is sought on this draft guidance by February 6. CHI staff is currently working with its members to formulate our detailed input on this draft.

Draft Changes to Various Guidance Documents in Light of 21st Century Cures Act Changes to Medical Device Definition

The FDA has also issued draft guidance titled Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act, which proposes modifications to four key guidance documents for the connected health tech community:

Further, the FDA proposes to withdraw one existing guidance document, Guidance for the Submission of Premarket Notifications for Medical Image Management Devices.

With the 21CC Act’s passage, the FDA is proposing to revise each guidance document per the alternations made to the definition of a medical device under section 520(o)(1)(A)-(D) of the Federal Food, Drug, and Cosmetic Act. In short, the 21CC Act restricted the FDA from regulating certain kinds of software, and the FDA is now revising its relevant guidance documents accordingly.

With the passage of the 21CC Act, the definition of a medical device must now exclude:

  • Software used for admin support of a healthcare facility (including “population management”);
  • Software that encourages a healthy lifestyle (unrelated to disease prevention or treatment);
  • Software that serves as an EHR and does not interpret or analyze for purposes of prevention or treatment; and
  • Software for storing/transferring/displaying data that does not interpret or analyze for purposes of prevention or treatment.

The FDA discusses each of the above categories of software and related changes needed in various guidance documents (and proposes that its rationale will be added to the ‘Background’ section of each guidance document once finalized), particularly to the examples listed in each. Notable proposals include:

  • Reinforcement by the FDA of its commitment to continue to not enforce applicable requirements for general wellness/healthy lifestyle software functions that present a low risk to the safety of users and other persons.

  • That mobile apps intended for individuals to “log, record, track, evaluate, or make decisions or behavioral suggestions related to developing or maintaining general fitness, health or wellness” be indicated as not qualifying as medical devices.

  • That electronic health record (EHR) software certified by HHS’ Office of the National Coordinator for Health IT (ONC) and mobile apps used to access an EHR are not considered medical devices.

  • That products solely intended to “transfer, store, convert formats, and display medical device data and results, including medical images, waveforms, signals, or other clinical information” are not medical devices

Public comment is sought on this draft guidance by February 6. CHI staff is currently working with its members to formulate our detailed input on this draft.

Final Guidance on Clinical Evaluation of Software as a Medical Device (SaMD)

The FDA has also issued final guidance titled Software as a Medical Device (SaMD): Clinical Evaluation. This guidance, adopting the approach to clinical evaluation of SaMD developed within the International Medical Device Regulatory Forum, is intended to provide “a path for global regulators to converge on terminology, a risk-based framework, an understanding of quality management system principles, and…an approach to making [SaMD] clinically meaningful to users.”

This extensive IMDRF-developed document approaches SaMD clinical safety, effectiveness, and performance evaluation through a process broken down into three areas: (1) valid clinical association, (2) analytical validation, and (3) clinical validation. Further, it describes how:

  • Clinical evaluation should be “an iterative and continuous process as part of the quality management system for medical devices.”
  • Certain SaMD may need “independent review of the results of the clinical evaluation” to validate its clinical value, “commensurate with the risk posed by the specific SaMD.”
  • SaMD manufacturers/developers should employ continuous monitoring of the safety, effectiveness, and performance of SaMD to understand and modify software based on real-world performance.

FDA’s Software Precertification Program

Building on extensive collaborative work with several key stakeholder groups (including CHI) across the last few years, in mid-2017 the FDA announced a new “Software Precertification Pilot Program.” The program aims to build a new streamlined approach to its regulation of software, including a precertification program for the assessment of companies that design and test software. At the time of this announcement, the FDA stated that it intends to “develop a precertification program that could replace the need for a premarket submission in some cases and allow for decreased submission content and/or faster review of marketing applications for software products in other cases.” CHI has publicly supported the FDA’s pilot program.

In September 2017, the FDA announced that nine organizations were accepted to participate in the pilot program. The FDA later announced plans to convene a public workshop on January 30-31, 2018, at the National Institute of Health’s main campus in Bethesda, Maryland. According to a detailed agenda, the workshop’s purpose is to “discuss the progress of the pilot precertification program and to seek input on the ongoing development of the Software Precertification Program.” CHI has been invited to participate in the workshop, and we look forward to playing a role in the development of this program.

Conclusion

CHI is thrilled to witness the significant steps the FDA is taking to modernize its approach to software-driven innovations in the healthcare space. We strongly support the FDA’s efforts to update oversight and regulation while providing American patients with safety and confidence in their care. Paired with recent breakthroughs, driven by CHI’s efforts, towards establishing reimbursement in the Medicare system (in both the CY 2018 Physician Fee Schedule and in the latest Quality Payment Program) for caregivers that wish to use remote monitoring tools to improve patient care while reducing costs, CHI continues to see evidence of, and grow more and more optimistic about, the ability of the IoT to transform American healthcare, also providing global leadership to other key market regulators.

We encourage you to reach out to us with your interest and views on any of the above as CHI moves forward into 2018.