Sunday, January 15, 2017

FDA Mobile App Regulations

This memorandum covers developing FDA regulations of Mobile Apps. To a great extent, the future of internet communication is via Apps. Some estimate that 80% of internet traffic will be Mobile App mediated by the end of the decade.

Bottom Line: The time to enter the Mobile App space may be now…

Here is an example of a Mobile App (for Dr. Rima Laibow) described here:

FDA Regs on Mobile Apps

Some of the questions being considered by the regulators:

-         How the FDA should categorize mobile apps and decides how, or whether, to regulate them as medical devices.
-         How the FDA evaluates an app's "intended use."
-         How to interpret the FDA's promise of "enforcement discretion" for certain types of apps.
-         Who can be considered a mobile medical app developer and what regulations affect them.

FDA's evolving stance on Mobile Apps sorts them into three categories:

-         Administrative health information technology (e.g, billing, claims processing, general communication and scheduling): This is not a medical device and not regulated by the agency.

-         Health management information technology (e.g., medication management, data capture, electronic access to clinical results, provider order entry): This is under FDA jurisdiction but generally so low risk that the agency can exercise enforcement discretion and not apply regulations.

-         Medical device health information technology (e.g., computer-aided detection and diagnosis, robotic surgical planning, remote display of bedside alarms, radiation treatment planning): This is actively regulated under Class I, Class II and Class III medical device rules.

Here is what the FDA is saying about Mobile Apps:

The widespread adoption and use of mobile technologies is opening new and innovative ways to improve health and health care delivery.

Mobile applications (apps) can help people manage their own health and wellness, promote healthy living, and gain access to useful information when and where they need it. These tools are being adopted almost as quickly as they can be developed. According to industry estimates, 500 million smartphone users worldwide will be using a health care application by 2015, and by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications ( -be-using-healthcare-mobile-applications-in-2015/). These users include health care professionals, consumers, and patients.

The FDA encourages the development of mobile medical apps that improve health care and provide consumers and health care professionals with valuable health information. The FDA also has a public health responsibility to oversee the safety and effectiveness of medical devices – including mobile medical apps.

The FDA issued the Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff (PDF - 269KB) on September 25, 2013, which explains the agency’s oversight of mobile medical apps as devices and our focus only on the apps that present a greater risk to patients if they don’t work as intended and on apps that cause smartphones or other mobile platforms to impact the functionality or performance of traditional medical devices.

What are mobile medical apps?

Mobile apps are software programs that run on smartphones and other mobile communication devices. They can also be accessories that attach to a smartphone or other mobile communication devices, or a combination of accessories and software.
Mobile medical apps are medical devices that are mobile apps, meet the definition of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.

Consumers can use both mobile medical apps and mobile apps to manage their own health and wellness, such as to monitor their caloric intake for healthy weight maintenance. 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.

Other apps aim to help health care professionals improve and facilitate patient care. The Radiation Emergency Medical Management (REMM) app gives health care providers guidance on diagnosing and treating radiation injuries. Some mobile medical apps can diagnose cancer or heart rhythm abnormalities, or function as the “central command” for a glucose meter used by an insulin-dependent diabetic patient.

How will the FDA regulate mobile medical apps?

The FDA will apply the same risk-based approach the agency uses to assure safety and effectiveness for other medical devices.  The guidance document (PDF - 269KB) provides examples of how the FDA might regulate certain moderate-risk (Class II) and high-risk (Class III) mobile medical apps. The guidance also provides examples of mobile apps that are not medical devices, mobile apps that the FDA intends to exercise enforcement discretion and mobile medical apps that the FDA will regulate in Appendix A, Appendix B and Appendix C.
We encourage app developers to contact the FDA – as early as possible – if they have any questions about their mobile app, its level of risk, and whether a premarket application is required.

Mobile medical apps that the FDA will regulate

The FDA is taking a tailored, risk-based approach that focuses on the small subset of mobile apps that meet the regulatory definition of “device” and that:

-         Are intended to be used as an accessory to a regulated medical device, or
-         Transform a mobile platform into a regulated medical device.

Mobile apps span a wide range of health functions. While many mobile apps carry minimal risk, those that can pose a greater risk to patients will require FDA review.

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

FDA’s mobile medical apps policy does not require mobile medical app developers to seek Agency re-evaluation for minor, iterative product changes.

Mobile apps for which the FDA intends to exercise enforcement discretion

For many mobile apps that meet the regulatory definition of a “device” but pose minimal risk to patients and consumers, the FDA will exercise enforcement discretions and will not expect manufacturers to submit premarket review applications or to register and list their apps with the FDA. This includes mobile medical apps that:

-         Help patients/users self-manage their disease or condition without providing specific treatment suggestions;
-         Provide patients with simple tools to organize and track their health information;
-         Provide easy access to information related to health conditions or treatments;
-         Help patients document, show or communicate potential medical conditions to health care providers;
-         Automate simple tasks for health care providers; or
-         Enable patients or providers to interact with Personal Health Records (PHR) or Electronic Health Record (EHR) systems.

Does the FDA regulate mobile devices and mobile app stores?

FDA’s mobile medical apps policy does not regulate the sale or general consumer use of smartphones or tablets. FDA’s mobile medical apps policy does not consider entities that exclusively distribute mobile apps, such as the owners and operators of the “iTunes App store” or the “Google Play store,” to be medical device manufacturers. FDA’s mobile medical apps policy does not consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by FDA.

Does the guidance apply to electronic health records?

FDA’s mobile medical app policy does not apply to mobile apps that function as an electronic health record (EHR) system or personal health record system.

House Passes HR5 to Redress Judicial "Deference"

Judicial Oversight of Federal Regulatory Bureaucrats
House Passes HR5 to Redress Judicial "Deference" To Agencies' Interpretation of Law - When Will Senate Send Bill to New President?

Regulatory Accountability Act of 2017 [1]

In a package of regulatory reforms just passed by the Federal House of Representatives, one stands out to me: legislative reversal of what is called "Chevron Deference" -- the deference Federal Judges were supposed to give to Federal Agencies when the bureaucrats "interpreted the law..." where the congressional statute is "ambiguous," thereby making it very difficult to have standing to sue to challenge regulatory restrictions. 

Now, however, judges will have to make a positive legal determination and not just rely on Agency positions as to the meaning of the law.

Here is how Wikipedia describes the Chevron case.

"Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), was a landmark case in which the United States Supreme Court set forth the legal test for determining whether to grant deference to a government agency's interpretation of a statute which it administers. Chevron is the Court's clearest articulation of the doctrine of "administrative deference," to the point that the Court itself has used the phrase "Chevron deference" in more recent cases." [2]

Under HR5 Congress tells judges that Federal Agencies cannot rely on their own interpretations of the law, but must now defer to the judges, who may consider, but are not bound by, agency positions on the meaning of even ambiguous statutes.  This is especially powerful with regard to FDA overreaching -- for example, when they try to ignore the Dietary Supplement Protection provision in the 2010 "Food Safety [sic] Modernization Act" by their restrictive interpretation of what is a "grandfathered" ingredient under DSHEA, the Dietary Health and Education Act of 1994.

Federal judges, often in dissent, have expressed misgivings about Chevron Deference. Circuit Judge Gorsuch*, defending the rule of law, expressed it this way last August:

"There’s an elephant in the room with us today. We have studiously attempted to work our way around it and even left it unremarked. But the fact is Chevron and Brand X permit executive bureaucracies to swallow huge amounts of core judicial and legislative power and concentrate federal power in a way that seems more than a little difficult to square with the Constitution of the framers’ design. Maybe the time has come to face the behemoth." [3]

As is often the case in Federal statutory changes, where one is dealing with very complex provisions, one must be careful to find the operative language. It appears the actual statutory language that accomplishes the reversal of Chevron Deference is here:

"Agency guidance... is not legally binding and may not be relied upon by an agency as legal grounds for agency action..." Bill Section 104.

Other provisions of the Bill as adopted by the House change some of the steps in the Administrative Procedures Act structure for the establishment of new Federal Regulations, making more effective the right of "stake holders" to challenge proposed regulations in Court.

The Republican Party maintained control of Congress with the promise that the party would sponsor a roll-back of the regulatory state. The party's successful presidential candidate made this one of his primary promises. The House has acted; now the Senate must consider how to further redress the imbalance between business and the bureaucracy, sending the matter to the new president for rapid final approval.

With HR5 and its several provisions changing the way in which Regulations are developed and adopted, significant changes in the balance between entrapreneurs and bureaucrats may be taking place.

The possibility is certainly worth watching...

Ralph Fucetola JD

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[1] "The Regulatory Accountability Act of 2017, which passed 238-183 Wednesday evening, rolled together a series of previously passed bills to repeal the Chevron deference standard and require mandatory litigation stays for new rules, among other reforms. "


[3] These excerpts from Judge Gorsuch's concurring opinion in a 2016 Tenth Circuit immigration case discuss the way Chevron Deference works, or rather, doesn't work, in actual judicial practice, calling upon Congress to act to change the case law. Congress is doing just that.

"No. 14-9585, Gutierrez-Brizuela v. Lynch
GORSUCH, Circuit Judge*, concurring.

There’s an elephant in the room with us today. We have studiously attempted to work our way around it and even left it unremarked. But the fact is Chevron and Brand X permit executive bureaucracies to swallow huge amounts of core judicial and legislative power and concentrate federal power in a way that seems more than a little difficult to square with the Constitution of the framers’ design. Maybe the time has come to face the behemoth.

In enlightenment theory and hard won experience under a tyrannical king the founders found proof of the wisdom of a government of separated powers. In the avowedly political legislature, the framers endowed the people’s representatives with the authority to prescribe new rules of general applicability prospectively. In the executive, they placed the task of ensuring the legislature’s rules are faithfully executed in the hands of a single person also responsive to the people. And in the judiciary, they charged individuals insulated from political pressures with the job of interpreting the law and applying it retroactively to resolve past disputes. This allocation of different sorts of power to different sorts of decision makers was no accident...

Even more importantly, the founders considered the separation of powers a vital guard against governmental encroachment on the people’s liberties, including all those later enumerated in the Bill of Rights...

When the political branches disagree with a judicial interpretation of existing law, the Constitution prescribes the appropriate remedial process. It’s called legislation. Admittedly, the legislative process can be an arduous one. But that’s no bug in the constitutional design: it is the very point of the design...

But acknowledging this much only brings the colossus now fully into view. In the Administrative Procedure Act (APA), Congress vested the courts with the power to “interpret . . . statutory provisions” and overturn agency action inconsistent with those interpretations. 5 U.S.C. § 706. Congress assigned the courts much the same job in the immigration field where we happen to find ourselves today. 8 U.S.C. § 1252(a)(2)(D). And there’s good reason to think that legislative assignments like these are often constitutionally compelled. After all, the question whether Congress has or hasn’t vested a private legal right in an individual “is, in its nature, judicial, and must be tried by the judicial authority.” Marbury v. Madison, 5 U.S. (1 Cranch) 137, 167 (1803)...

All of which raises this question: what would happen in a world without Chevron? If this goliath of modern administrative law were to fall? Surely Congress could and would continue to pass statutes for executive agencies to enforce. And just as surely agencies could and would continue to offer guidance on how they intend to enforce those statutes. The only difference would be that courts would then fulfill their duty to exercise their independent judgment about what the law is. Of course, courts could and would consult agency views and apply the agency’s interpretation when it accords with the best reading of a statute. But de novo judicial review of the law’s meaning would limit the ability of an agency to alter and amend existing law. It would avoid the due process and equal protection problems of the kind documented in our decisions...."
* Subsequent to this Blog Entry, now Justice Gorsuch became a member of the US Supreme Court, so perhaps we should now call his views on this matter "The Gorsuch Doctrine."