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

ABSTRACT

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. B.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. 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, diagnostic software, and diagnostic repair tools provided to licensed dealerships by their respective automobile manufacturers.30 Specifically, the law required motor vehicle manufacturers to "make available for purchase by owners . . . and by independent repair facilities the same diagnostic and repair information" and "all diagnostic repair tools" provided to dealers by OEMs on "fair and reasonable terms. In 2014, the Alliance of Automobile Manufacturers, the Association of Global Automakers, and two automobile aftermarket industry groups came together to sign a "Memorandum of Understanding" by which the automobile industry nationwide effectively agreed to voluntarily abide by substantively the same provisions of the Massachusetts right-to-repair law.32 Unsurprisingly, the law generated considerable momentum for the right-to-repair movement over the following years, which saw a greatly amplified nationwide effort by advocates pushing for legislation "that would recognize the right to repair consumer electronics-not only smartphones, laptops, and televisions, but also household appliances, wearable technology, farm equipment, and medical devices, to offer just a few examples.