Digital Health and FDA – Part Two

We previously discussed the FDA’s role in the regulation of digital health products – specifically medical devices and Software as a Medical Device. We continue the discussion about the FDA’s role in regulating medical device data systems, medical apps, and other forms of digital health here.

Medical device data systems

Medical Device Data Systems (MDDS) are hardware or software products – that aim to:

• Transfer
• Store
• Convert (formats)
• And display medical device data

An MDDS doesn’t change the data and doesn’t “by itself control the functions or parameters of any other medical device.” Some, but not all MDDS devices are used for patient monitoring.

The Federal Food, Drug, and Cosmetic Act (Section 520(o)(1)(D)) provides that:

“The FDA does not regulate software functions if their sole purpose is to “transfer, store, convert formats, or display medical device data or medical imaging data.” In short, the FDA doesn’t regulate software functions that are categorized as a “Non-Device-MDDS.” The FDA also doesn’t regulate hardware functions “that are solely intended to transfer, store, convert formats, and display medical device data or results” – a “Device-MDDS.”

A few examples of a Non-Device-MDDS include software functions that:

• Stores blood pressure readings that can be reviewed at a later time by a nurse, doctor, or another healthcare provider
• Converts pulse oximeter data into a printable format
• Displays a prior stored electrocardiogram for a particular patient.

What is Medical device interoperability?

The FDA defines “Medical device interoperability” as:

“The ability to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems.” The information can then be displayed, analyzed, and stored automatically on or controlled by another product.”

More and more electronic medical devices are becoming interconnected. The ability to have these systems work with other – safely and securely – is becoming increasingly important.

On the plus side, the interoperability of medical devices helps:

• Improve the medical care patients receive
• Reduces mistakes and adverse events
• Encourages new ideas
• Enables more robust research

On the negative side, there are increasing cybersecurity concerns with medical device interoperability. We spoke briefly about FDA and digital health cybersecurity in part one of our discussion.

The FDA’s role in medical device data systems

As with most other digital health issues, the FDA is interested in the balance of providing better health care while protecting the safety and privacy of patients. The FDA is working with medical practices, hospitals, developers, and others to promote medical device interoperability. Some of these collaboration efforts include partnerships with other agencies such as the US Centers for Disease Control and Prevention and the National Library of Medicine (NLM) of the National Institutes of Health (NIH).

“For over two years (2020-2022) during the COVID-19 public health emergency, the FDA’s CDRH led the way in diagnostic data interoperability for SARS-CoV-2 in vitro diagnostic tests. Efforts in collaboration with HHS and across the interagency led to significant progress in the standardization, harmonization, and transmission of diagnostic data to inform clinical and public health decisions.”

“The FDA issued the final guidance, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices, in 2017. This guidance helps manufacturers design and develop safe, effective, and interoperable medical devices by outlining important design considerations and providing clarity on the agency’s recommendations for submitting interoperability-related information in premarket submissions and labeling.”

The FDA also understands the importance of reliable interoperable medical device standards. “In 2013, the FDA officially recognized an initial set of standards manufacturers could use to improve patient care by making sure devices work well together.” To verify which standards the FDA currently recognizes, please refer to the FDA Recognized Consensus Standards Database.

The FDA focuses on balancing the need for new mobile medical apps (MMAs) to assist health care professionals and patients while also reviewing the safety and effectiveness of medical devices – including mobile medical apps. The FDA uses the Policy for Device Software Functions and Mobile Medical Applications Guidance, to explain the FDA’s oversight of device software functions, including mobile medical apps.

The FDA’s mobile medical applications website provides questions and answers to a few questions about current FDA oversight of MMAs.

What are mobile medical apps?

Mobile medical apps are medical devices that:

• Are mobile apps (software programs that run on smartphones and other mobile communication devices – or accessories/attachments to a smartphone or other mobile communication devices)
• Meet the definition of a medical device
• Are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.

Consumers can use mobile medical apps to manage their health and to monitor their health. “For example, the National Institutes of Health’s LactMed app provides nursing mothers with information about the effects of medicines on breast milk and nursing infants.”

Health care professionals may use apps to improve and facilitate patient care. For example, some mobile apps can diagnose cancer, heart rhythm abnormalities, radiation injuries, or “function as the ‘central command’ for a glucose meter used by an insulin-dependent diabetic patient.”

How does the FDA regulate device software functions?

The FDA regulates medical apps as it does other medical devices. The FDA guidance document includes examples of how the agency “might regulate certain moderate-risk (Class II) and high-risk (Class III) device software functions.” The FDA classifies medical devices into three categories  – Class I, Class II, and Class III, based on the risk the devices pose to consumers, the intended use, and indications for use.

The guidance document also includes examples of software functions that:

• Are not medical devices,
• Are medical devices, but for which the FDA intends to exercise enforcement discretion
• Are medical devices and are the focus of FDA oversight.

What device software functions are the focus of FDA oversight

The FDA is currently focusing on the “subset of software functions that meet the regulatory definition of “device.” Software functions span a wide range of health functions. While some software carries minimal risk, those that can pose a greater risk to patients will require FDA review.”

“For more information, please see examples of premarket submissions of MMAs that are cleared or approved by the FDA and examples of device software functions the FDA regulates for a detailed list of examples of software that are medical devices and would require FDA review.”

“For a list of what is considered a device software function, manufacturers and developers can search the FDA’s public database of existing classification by type of software (for example, diagnostic). Approved/cleared device software functions will also be listed in the FDA’s 510(k) and PMA databases and on the FDA’s Registration & Listing Database.”

The FDA does not regulate the sale or general consumer use of smartphones or tablets.

To determine if you have a mobile medical app, see Section V.A. of the FDA’s Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff [PDF].

Examples of current health apps

Some of the many new health apps that healthcare professionals and consumers are using include the following, according to Prevention.com. The publication spoke with doctors, registered dietitians, and other experts as part of its research:

• Meditation apps
• Workout apps
• Apps that help women track their periods – along with their mood and sleep.
• Apps for walkers
• Apps for runners
• Apps to track how hydrated a user is
• Apps to track a user’s sleep
• Skincare apps that let users track the products people use, create routines, and track their skin’s progress
• Nutritional apps

Doctors are using health care apps for:

• Clinical support decision tools
• Digital images showing what different diseases look like
• Communication and network apps
• Medical glossaries
• Medical innovation apps

Some of the main concerns doctors have about medical apps include:

• Mobility and connectivity.
• Data security
• Compatibility with the latest medical instruments
• GPS to track patients and alter doctors to medical emergencies
• An ability to quickly allow patients and doctors to chat

Health information technology

FDA also reviews Non-device software functions.

“Section 3060(b) of the 21st Century Cures Act requires a report to be published every two years that examines information available to the Secretary on any risks and benefits to health associated with the software functions described in section 520(o)(1) of the FD&C Act, and provides summary findings on the impact of non-device software functions on patient safety, including best practices.”

The FDA, FCC, and ONC (Office of the National Coordinator for Health IT) are all working together to develop recommendations for a risk-based regulatory framework) for health IT – including an April 2014 FDASIA Health IT Report outlining a proposed strategy and recommendations for a risk-based framework.

The FDA does regulate various forms of digital health. New regulations are continually being developed as the technology uses expand. The FDA is prioritizing some products over other products. Digital health includes medical device data systems, mobile medical apps, and software functions. Developers and healthcare practices need to comply with FDA regulations and other federal and state regulations of digital health.

Digital health manufacturers and medical practices should contact Cohen Healthcare Law Group, PC to discuss what federal and state laws regulate the design, marketing, and use of digital health products. Our experienced healthcare attorneys help doctors and medical businesses understand FDA and other regulatory compliance issues.