What are Mobile Mental Health Apps and How Are the Apps Regulated? Part Two

Mobile mental health apps help patients monitor their behavior, become educated about anxiety and other mental health issues, and help alert caregivers about possible emergencies. Many apps, as we discussed in part one of our discussion, are being funded by the National Institute of Mental Health.

There are many concerns about the efficacy and safety of mobile mental health apps. Manufacturers and physicians both need to understand the federal and state laws that govern software apps that provide medical services. Some apps may be regulated by the FDA and the FTC. There are laws that govern the ethical and legal practice of medicine. Physicians need to understand when relationships with vendors may violate Stark Law, the Anti-Kickback Statute, and other laws.

What role does the NIMH play in mental health intervention technology?

The NIMH has issued numerous grants to help improve mental health services. Many of these grants were issued through the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs. The grants include technology for specific disorders such as depression, trauma, anxiety, illness management, and behavior. The trend is shifting away from desktop applications to smartphone applications. The newer applications tend to be friendlier and more interactive. The apps also help users exchange information with professionals and peers when necessary.

Going forward, the NIMH expects new research on:

• Using mobile technology for a wider range of disorders, from mild depression or anxiety to schizophrenia, autism, and suicide
• Developing and refining new interventions, instead of adapting existing interventions to work with new technologies
• Developing technologies that work on any device
• Incorporating face-to-face contact or remote counseling (phone or online) to provide a balance between technology and the “human touch”

Can the FDA regulate mobile mental health apps?

We previously wrote a two-part series on Digital Health and the FDA. This discussion focuses more on the types of mobile mental health apps we’ve been talking about – rather than discussing telemedicine, AI, cybersecurity, and other broader digital health issues.

Generally, the FDA does not regulate the sale of smartphones or tablets. Nor does the FDA generally consider that the distributors of mobile apps, such as the owners and operators of the “iTunes App Store” or the “Google Play Store,” to be medical device manufacturers. Generally, the FDA does not consider that mobile platform manufacturers are medical device manufacturers “just because their mobile platform could be used to run a mobile medical app regulated by the FDA.”

Oversight of medical software apps

The FDA is aware of the benefits and risks of mobile health apps to public health. The FDA has prepared this guidance document to inform manufacturers, distributors, and other entities about FDA oversight of software applications – including health applications.

FDA refers to software functions that are device functions as “device software functions.”   Generally, the FDA has three categories of device software functions/medical software:

• Software, which on its own is a medical device – Software as a Medical Device (SaaMD)
• Software that is integral to a medical device – software in a medical device.
• Software used in the manufacture or maintenance of a medical device.

The term Software as a Medical Device is defined by the International Medical Device Regulators Forum (IMDRF) as

“software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” 

SaaMD can be used in many different platforms including medical device platforms, virtual networks, and commercial off-the-shelf platforms. Previously, SaaMD software was called medical device software, health software, or standalone software. SaaMD is also known as a “mobile medical app.”

The FDA states that regulators worldwide are working on common SaaMD principles to balance innovation with patient safety.

“The IMDRF in 2013, formed the Software as a Medical Device Working Group (WG) to develop guidance supporting innovation and timely access to safe and effective Software as a Medical Device globally.”

The policies in the guidance document “are independent of the platform on which they might run, are function-specific, and apply across platforms.” This means the policies apply to smartphones, desktops, and other computing platforms.

FDA regulation of medical devices

The FDA regulates medical devices pursuant to its authority section 201 (h) of the federal Food, Drug and Cosmetic Act (FD&C Act). Skilled healthcare lawyers understand when software functions are regulated as medical devices and when the FDA does not regulate the software as devices. Also, while some software may qualify as a medical device, the FDA may not prioritize enforcement of the software/medical device.

The FDA states that the agency does intend to

“Apply its regulatory oversight to only those software functions that are medical devices and whose functionality could pose a risk to a patient’s safety if the device were to not function as intended.”

The guidance document was recently updated to be consistent with the appropriate section of the 21st Century Cures Act

“which amended section 520 of the FD&C Act, removing certain software functions from the definition of device in section 201(h) of the FD&C Act, and the guidance document entitled “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,” originally issued on February 9, 2015.

The 21st Century Cures Act creates a “function-specific definition” for medical devices.

Device software functions including mobile medical applications

Mobile medical apps help consumers manage their health and wellness while gaining access to useful healthcare information. As of 2017, the FDA estimates that users could access 325,000 health care apps on smartphones – about 3.7 billion mobile health application downloads for the year. The users include consumers, patients, and health care professionals.

The initial guidance document for device software functions and mobile medical applications was modified in 2015 and 2019. The guidance document indicated that FDA’s focus is on –

“Software that presents a greater risk to patients if it doesn’t work as intended and on software that causes smartphones, computers, or other mobile platforms to impact the functionality or performance of traditional medical devices.”

How does the FDA define medical apps?

Essentially, mobile medical apps are medical devices that:

• Are mobile apps
• 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.”

Examples of consumer mobile medical apps include software that monitors a user’s calorie intake. Mothers may use a nursing app to monitor the effects of medications on breast milk and nursing their infants. Examples of physician medical apps include apps that provide help in diagnosing and treating radiation injuries. Apps may help diagnose cancer or heart rhythm abnormalities. Diabetics may use medical apps to monitor their glucose levels. Other apps may help people with mental health challenges in the various ways we’ve discussed.

How does the FDA regulate device software functions?

Generally, the FDA analyzes medical software apps the ways the agency analyzes other software devices. This includes different types of guidance for high-risk device software functions, moderate-risk device software functions, and low-risk device software functions.

Which device software functions that are the focus of FDA oversight

Manufacturers and developers can review numerous FDA web links for information about FDA oversight of device software functions including:

• Examples of premarket submissions of MMAs that are cleared or approved by the FDA
• Examples of device software functions the FDA regulates
• 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.

Generally, FDA approval is not required for re-evaluating minor, iterative product changes.

Examples of software functions that may and may not be regulated by the FDA

Generally, FDA oversight of mobile mental health apps that pose a low risk to consumers and patients will be done at the FDA’s discretion. FDA generally does “not expect manufacturers to submit premarket review applications or to register and list their software with the FDA.” Generally, this limited oversight applies to device software functions that:

• “Help patients/users self-manage their disease or condition without providing specific treatment suggestions. Many of the mobile mental health apps we discussed in part one fall into this category.
• Automate simple tasks for health care providers.”

Some mobile mental health apps will require a higher level of FDA oversight. The FDA guidance document does state, for example:

Enforcement likely to be exercised. “The following examples represent software functions for which the FDA intends to exercise enforcement discretion:”

“Software functions that provide or facilitate supplemental clinical care, by coaching or prompting, to help patients manage their health in their daily environment. These are software functions that supplement professional clinical care by facilitating behavioral change or coaching patients with specific diseases or identifiable health conditions in their daily environment.”

Enforcement NOT likely to be exercised. “Specific examples of software functions that FDA does not consider to be devices and with no regulatory requirements under the current laws administered by FDA include:

Software functions that are intended for individuals to log, record, track, evaluate, or make decisions or behavioral suggestions related to developing or maintaining general fitness, health or wellness, such as those that:

• Provide daily motivational tips (e.g., via text or other types of messaging) to reduce stress and promote a positive mental outlook
• Use social gaming to encourage healthy lifestyle habits”

Our skilled healthcare professionals can help you assess what level of oversight is necessary for your mobile mental health app.

What other federal and state regulations govern mobile mental health apps?

There are many other issues that manufacturers and physicians need to review with our healthcare lawyers when they design, manufacture, sell, recommend, or use mobile mental health apps. These issues depend on the type of the device, the functionality of the device, whether the patient is in direct communication with a physician, and many other factors.

We discussed some of these factors in our article – Mental and Behavioral Health Compliance and Business Issues.

Some of the issues that require legal review include:

• What type of mental health service is being provided? Mental health includes psychology, social work, life coaching, family and marriage therapists, addiction counseling, and many other types of mental health care.
• Does the app qualify as telehealth or telemedicine? If so, what telehealth and telemedicine laws apply such as the rules of the Centers for Medicare and Medicaid Services.
• What privacy issues apply? The Health Insurance Portability and Accountability Act of 1996 (HIPAA) protects patient information including electronic patient information. States such as California have their own privacy protection laws including the Confidentiality of Medical Information Act (CMIA).
• Does a relationship between a physician and a manufacturer or other vendor violate anti-referral laws such as Stark and the Anti-Kickback Statute (AKS)?
• Does the software make false promises on its print materials, website, social medica accounts, and other marketing platforms?
• Does the software comply with the federal Substance Abuse and Mental Health Services Administration (SAMHSA) that govern substance abuse?
• Does the mobile mental health app comply with the state licensing laws and the authorized practice of medicine laws?
• Does the app comply with rules governing professional medical corporations?
• Do any faith-based health care laws apply?

If you work in the mental health profession; whether as a manufacturer, software developer, physician, or mental health counselor – you need to be careful. There are federal and state laws that regulate healthcare software devices. If the FDA classifies your app as a medical device, the device will need to undergo a rigorous review before the can be made or sold. If the device requires any private personal information, the device may violate privacy laws. Financial arrangements between physicians and manufacturers are immediately suspect.

The manufacturers of mental health mobile apps and the doctors who recommend mobile mental health apps should contact Cohen Healthcare Law Group, PC to review the federal and state laws that apply to the design, sale, and use of these apps. Our experienced healthcare attorneys advise medical health companies and physicians about healthcare compliance laws and regulations.