SMART WEARABLES: THE OVERLOOKED AND UNDERRATED ESSENTIAL WORKER.

• Author: Hill, Rebekah

TABLE OF CONTENTS INTRODUCTION 1584 I. CURRENT LEGISLATION 1588 A. FDA Regulations 1589 1. FDA's Classification of Medical Devices 1590 2. Intended Purpose vs. Actual Use of Smart Wearables 1592 B. Intersection of the SMARTWATCH Data Act, HIPAA Privacy Rule, and FDA Regulations 1594 II. ADDRESSING ALTERNATIVE APPROACHES 1596 A. FDA Pilot Program: Digital Health Software Precertification Program 1597 B. Amending HIPAA Privacy Rules to Extend Applicability to Smart Wearables 1599 III. SOLUTION: THE FDA SHOULD AMEND THE DEFINITION OF "MEDICAL DEVICE" TO UNAMBIGUOUSLY INCLUDE SMART WEARABLES 1600 A. Proposed Amendment to the FDA's Definition of "Medical Device". 1601 B. Smart Wearables Fall Within the Scope of the FDA's Current Definition of "Medical Device" 1604 1. Essential Aids for COVID-19 Contact Tracing 1604 2. Essential Aids for Monitoring COVID-19 Symptoms 1608 C. The Future of Smart Wearables 1609 1. Examples of Modernized Smart Wearable Technology 1610 2. Smart Wearables Are Capable of Detecting Infectious Diseases 1613 CONCLUSION 1614 INTRODUCTION

Eighty-three thousand deaths, 1.7 million injuries--all linked to medical device malfunction in the decade leading up to 2018. (1) Investigative researchers question if these numbers are entirely accurate; the statistics are likely underrepresentative of the harm caused by medical device malfunctions. (2) Many believe that the Food and Drug Administration (FDA)--the agency that, in part, regulates medical devices--buries evidence of device malfunction in an attempt to retain its reputation as the powerhouse of safety, efficacy, and innovation. (3) But does the FDA weigh one of those characteristics higher than the others? (Hint: it does). Should it? (Hint: it should not). Public safety and product efficacy are important to the FDA, but the tendency for the agency to cover up device malfunction to prevent device recalls suggests that its primary goal is to put devices on the market quickly. (4) Public awareness of these efforts by the FDA has influenced a movement to establish stricter regulations on smart wearables, especially as smart wearables become increasingly popular in society. (5) If the FDA requires the regulation of a product as simple as a wooden tongue depressor, (6) there is no question that the agency should require more stringent regulations for complex, continuously evolving devices such as smart wearables.

Smart wearables are capable of monitoring, mitigating issues with, and providing information about an individual's physiological data. (7) Additionally, studies suggest that smart wearables are potentially capable of diagnosing infectious disease. (8) The FDA is not devoid of regulations for smart wearables, but there is ambiguity in the FDA's guidelines that can harm the safety and well-being of society and ultimately hinder innovation.

To keep up with its reputation as "a global leader in setting standards and guidelines for the safety and efficacy of medical technologies," the FDA has introduced initiatives to modernize innovation. (9) This suggests that the agency recognizes its role in properly regulating devices; (10) thus, the FDA's ongoing failure to properly regulate smart wearables is incongruous with its professed goals. However, the FDA is not the only entity to blame for the lack of regulation of smart wearables. Smart wearable manufacturers have realized that they can bypass FDA regulations by strategically marketing their devices with language that falls outside the scope of the definition of a "medical device" under section 201(h) of the Food, Drug, and Cosmetic Act (FDCA). (11) This is not because the device fails to function as a medical device, but rather because loopholes in the FDA's definition of a "medical device" have allowed companies to avoid the often rigorous FDA approval process by simply altering the promotion of their devices. (12) This type of manipulation should not be tolerated by the FDA, especially when it concerns the medical health and safety of people.

Historically, the FDA has been held in high regard among a variety of audiences because of the various and diverse relationships that the agency maintains. (13) For example, both liberal and conservative American politicians "heap praise upon the agency" when making arguments for their policy proposals. (14) Moreover, the FDA's "protective image" has retained its powerful reputation in business and medical disciplines, which amplifies the public's trust in the FDA and consequently in private entities and the products that it regulates. (10) Recently, however, the FDA's reputation is beginning to tarnish, (16) and because so many people rely on the FDA's guidance, (17) it must restore its reputation as a reliable agency in order to retain the public's trust. (18)

The ultimate goal is for the FDA to adjust its regulations to realign with its proclaimed mission statement:

The [FDA] is responsible for protecting the public health by ensuring the safety, efficacy, and security of... medical devices; and... is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products... to maintain and improve their health. (19) This Note argues that the FDA should revamp its criteria for regulating medical devices to unambiguously include smart wearables. Specifically, this Note calls for the FDA to amend its definition of "medical device" to focus on what a device is technologically capable of rather than its intended use.

Part I will examine the established legislation regarding medical devices; in particular, it will examine the relationship between FDA regulations and the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and argue that when taken together, HIPAA creates a strong presumption that smart wearables should be regulated by the FDA. This Part will also discuss a recent legislative proposal that supports the call for smart wearable regulation. Part II will address alternative approaches for the proper regulation of smart wearables. Finally, Part III proposes a unique solution for regulating smart wearables as medical devices and will discuss various policy implications and will address and rebut counterclaims. Additionally, this Part considers the argument that smart wearables fit within the scope of the FDA's current definition of a medical device and identifies loopholes that prevent them from being sufficiently regulated. This Part will conclude by providing examples of modernized smart wearables that demonstrate the need for smart wearables to be subject to the FDA's medical device regulations.

1. CURRENT LEGISLATION

   The FDA is not the only entity concerned with smart wearable technology. Legislators and the Department of Health and Human Service's Office for Civil Rights (OCR) are also interested in the regulation of smart wearables. (20) Various legislators have shown their interests in protecting the privacy of smart wearables through the introduction of the Stop Marketing And Revealing The Wearables And Trackers Consumer Health (SMARTWATCH) Data Act, which would be enforced by the OCR. (21) Similarly, the OCR enforces the HIPAA Privacy Rule, (22) with the "major goal of... assur[ing] that individuals' health information is properly protected while allowing the flow of health information needed to provide and promote high quality health care and to protect the public's health and well being." (23) The introduction of the SMARTWATCH Data Act and the goals of HIPAA demonstrate that multiple intertwined entities are concerned with the proper regulation of medical devices. This Part first explores the FDA's regulation of medical devices, then establishes a nexus between the FDA's safety and efficacy concerns and the OCR's privacy concerns, and ultimately concludes that both regulators are working toward the same goal: protecting the users of smart wearables.

   1. FDA Regulations

      A product is subject to FDA regulation as a medical device if it satisfies the definition of "medical device" per section 201(h) of the FDCA. (24) The relevant portion of section 201(h) of the FDCA provides that a medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component part, or accessory, which is... intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man.

      Moreover,the FDA recognizes three regulatory classifications--Class I, Class II, and Class III--for generic devices, each with distinct protocols. (26) Every generic device that is introduced to the FDA is assigned to one of the classes based on the level of control needed to ensure that the device is safe and effective. (2)' The potential risk to the user if the product fails is a primary factor in determining how the product should be regulated. (28) However, the FDA reserves the right of enforcement discretion--that is, the agency has the authority to regulate devices that are on the cusp of the risk inquiry. (29) The FDA has issued guidance stating that it will not regulate device features that make general wellness claims. (30) General wellness features include calorie trackers and pulse rate trackers for use during exercise. (31) The FDA's right of enforcement discretion leaves the status of smart wearables as general wellness devices or medical devices up for debate.

      1. FDA's Classification of Medical Devices

         Typically, "Class I devices... pose the lowest risk to the patient and/or user and Class III devices pose the highest risk." (32) The necessary dependent factors that determine which class a device belongs to are (1) the intended use of the device and (2) the device's indications for use. (33)

         Class I devices...