Time for a Tune Up in America's Healthcare Market: Securing the Right to Repair for Medical Devices.

• Author: Louviere, Benjamin J.

1. Introduction 183 II. Background 185 A. The Modern Consumer's Encounter with Repair Restrictions 185 B. The Right-to-Repair Movement Today 187 C. Right to Repair in the Courts: Conventional Restrictions and the Twin-Bulwarks of Intellectual Property Law and Contract Law 189 1. Intellectual Property Reforms Targeted by the Repair Movement 189 2. EULAs Ensnaring Consumers in State Contract Law 192 D. The Federal Executive Branch Broadly Supports the Right-to-Repair Movement 193 III. Analysis 195 A. Repair Restrictions are a Chronic Problem in American Healthcare 196 B. COVID-19 Revealed the Untenable Fragility of Perpetuating Medical Device Repair Restrictions 197 C. Data Reveals the Need for Medical Device Right to Repair Regardless of an Active Public Health Emergency 198 D. The Need for Uniformity Requires Federal Legislative Intervention 199 IV. Recommendation 202 A. Basic Provisions Guaranteeing Access to Necessary Medical Device Repair Materials 203 B. Changes to Intellectual Property Law and Contract Law to Accommodate the Medical Device Right to Repair 203 C. FDA Oversight of Medical Device Repair Necessary to Secure a Sound Repair Reform 204 V. Conclusion 204 I. INTRODUCTION

   "The concept behind this is as old as it is simple: if you own something, you own all of it, including the right to repair it." (1) Thus remarked New York Representative Joe Morelle on June 30, 2021, upon introducing the Fair Repair Act--the first federal bill broadly advancing the consumer protection concept known as the "right to repair." (2) This expansive bill followed closely on the heels of a substantially narrower proposal, although borne of the very same concept, made in the form of two identical bills entitled the Critical Medical Infrastructure Right-to-Repair Act. (3) Lawmakers introduced these two bills in the House of Representatives and the Senate in August 2020, in the heat of a summer defined by the COVID-19 global pandemic's destabilizing foray into American life. (4) While none of these federal bills have advanced beyond committee consideration at the time of this writing, their proposal alone reflects the culmination of a major groundswell of consumer-driven demands for true ownership occurring in the American economy. This movement of broadly drawn constituents finds itself united under the banner of the "right to repair," an idea now poised like a battering ram at the doors of several major economic sectors, including, notably, the medical device industry.

   What, then, is the right to repair? In the abstract, the idea is that once a consumer purchases a product from its manufacturer, the consumer should thereupon be entitled to complete ownership and control over that product. That is, the consumer "should be able to open, hack, repair, upgrade, or tie bells on it." (5) This simple notion of unfettered ownership stands in stark contrast to the dismayingly complicated reality consumers face today. Manufacturers significantly restrict repairs on their products in a panoply of ways, from physical design barriers inhibiting reparability to more intangible barriers such as restrictive license and warranty agreements, exclusive repair networks, the withholding of technical information and repair materials, and assertions of the protective rights afforded by the current regime of American intellectual property law. (6) Thus, advocates of the right to repair wish to see, mainly by way of legislative reform, the demolition of these restrictions to the extent necessary to enable consumers to repair their own products or have independent third-party repair businesses do so, which requires "access to the same diagnostics, information, and parts available to the dealer's facilities." (7)

   This Note argues that the COVID-19 pandemic cast into sharp relief the pressing need for Congress to intervene and pass right-to-repair legislation, at least with respect to medical devices for hospitals. Part II of this Note introduces the relevant technical and legal concepts implicated by repair restrictions and examines the right-to-repair movement's origins and recent developments. Part III analyzes the unique nature of today's healthcare sector, finding this market to be in special need of the right to repair, and addresses the shortcomings of extant copyright and contract law insofar as the current law stands in the way of achieving such consumer protections. Part IV recommends that, regardless of a public health exigency such as the COVID-19 pandemic, Congress should move forward to adopt legislation guaranteeing a permanent right to repair medical devices--the enactment of which would serve not only as a preventative measure to protect Americans from future public health crises in an increasingly globalized world but would also function as a foothold for the advancement of broader repair legislation in years to come.

2. BACKGROUND

   1. The Modern Consumer's Encounter with Repair Restrictions

      According to some estimates, the business of repairs constitutes up to three percent of the U.S. economy. (8) After-market repair and maintenance services for products provide "a lucrative revenue stream that original equipment manufacturers [(OEMs)] are incentivized to capitalize on," and indeed they do. (9) Although the United States did not always have restrictive repair markets, (10) technological advancements and the evolution of modern industry--most notably the "electrification and computerization of products," including the ubiquitous proliferation of embedded software within everyday products--have made it much easier and more profitable for OEMs to deprive consumers of their ability to make after-market repairs. (11)

      Today, OEMs employ an overwhelming variety of tactics to secure control over repair and maintenance markets. Pursuant to a directive of Congress, the Federal Trade Commission (FTC) issued a report in May of 2021 examining consumer protection and antitrust issues relating to repair restrictions with a focus on the prevailing practices of mobile phone and auto manufacturers. (12) In its report, the FTC identified eight primary methods by which OEMs restrict independent repair and repair by consumers:

      * Product designs that complicate or prevent repair;

      * Unavailability of parts and repair information;

      * Designs that make independent repairs less safe;

      * Policies or statements that steer consumers to manufacturer repair networks;

      * Application of patent rights and enforcement of trademarks;

      * Disparagement of non-OEM parts and independent repair;

      * Software locks and firmware updates; and

      * End User License Agreements. (13)

      Software locks, often called digital rights management (DRM) tools or technological protection measures (TPMs), are access controls through which OEMs have throttled independent repairs on a wide range of software-enabled products. (14) End-user license agreements (EULAs) are "contracts that users must agree to before using a product or service," which are also known as "click-wrap," "shrink-wrap," or "terms of service" agreements, constituting another major way OEMs restrict repairs. (15) In the style of adhesion contracts--inundating consumers with virtually every digital service and software-enabled product they utilize--EULAs often impose post-sale usage, repair, and modification restrictions, granting corporations "unprecedented access to monitor, manage, and restrict how consumers use their products, even going so far as to revoke ownership." (16)

      These restrictions indeed drive at the heart of ownership (or, perhaps more accurately, its erosion) in the modern economy. By some accounts, the American economic landscape appears to be transforming into a "sharing economy" of temporary access, wherein the individual's control over goods is being transmuted into the mere provision of a service. (17 ) In this way--with consumers tethered to OEMs via post-transaction repair restrictions--stakeholders contend that these major OEM corporations monopolize repair markets at a substantial societal cost. (18) The character of the right-to-repair movement's war against this broad economic transformation is described in Part II.B, and its particular battles with these specific repair restrictions, waged in the theaters of federal intellectual property law and state contract law, are briefly illustrated in Part II.C.

   2. The Right-to-Repair Movement Today

      Leading the charge for the right-to-repair movement today is the Repair Association, comprised of notable consumer-rights groups and industry organizations such as the U.S. Public Interest Research Group (PIRG), (19) the Electronic Frontier Foundation, (20) and iFixit, (21) along with a variety of other members whose interests align with advancing the right to repair. (22) The right-to-repair movement consists of two main, interdependent branches. (23) The first is focused on amending the Digital Millennium Copyright Act (DMCA), (24) an important facet of the federal intellectual property law regime. (25) The second branch of the movement is focused on pushing bills through legislatures, mainly at the state level. These proposed bills seek to alleviate restrictions on repair--beyond the scope of the Copyright Act and the DMCA--and are grounded in state contract law, mainly with respect to EULAs. (26)

      The right-to-repair movement's lodestar for legislative progress, which has substantially shaped the national conversation surrounding the right to repair, (27) is the Massachusetts automotive repair bill enacted in 2012: The Act Protecting Motor Vehicle Owners and Small Businesses in Repairing Motor Vehicles. (28) Although limited to automobile repairs, this landmark state law mapped the core provisions of template legislation advanced by the Repair Association for enshrining the right to repair broadly across industries. (29) Pursuant to these provisions, the Massachusetts law gave car owners and independent repair shops access to the same manuals...