Title: Critical Medical Infrastructure Right-to-Repair Act of 2020
Policy area: Commerce

Summary:
Critical Medical Infrastructure Right-to-Repair Act of 2020
This bill removes certain intellectual property-related restrictions on repairing or maintaining critical medical infrastructure (i.e., a device or product used to provide medical services).
During the declared COVID-19 (i.e., coronavirus disease 2019) emergency, it shall not be copyright infringement for an owner or licensee of service materials (such as manuals or computer diagnostic software) to copy such materials if (1) the copying is incidental to the repair or maintenance of critical medical infrastructure, and (2) such repair or maintenance is in response to the emergency.
Similarly, during the emergency, the prohibition against circumventing technology to control access to a work (or trafficking in circumvention tools) shall not apply to an owner or licensee of critical medical infrastructure if the circumvention is done to repair or maintain critical medical infrastructure in response to the emergency.
During the emergency, it shall also not be design patent infringement if the owner or licensee of critical medical infrastructure fabricates a patented part on a noncommercial basis in order to repair or maintain the infrastructure in response to the emergency.
The bill also nullifies any contract provision that restricts the ability of the owner or licensee of critical medical infrastructure to repair or maintain such infrastructure in response to the emergency.
The manufacturer of critical medical infrastructure shall (1) offer for sale on reasonable terms any tool or information for servicing or repairing such infrastructure, and (2) provide information for making such tools to aftermarket tool manufacturers. The Federal Trade Commission shall have the authority to enforce these requirements.


[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 4473 Introduced in Senate (IS)]

<DOC>






116th CONGRESS
  2d Session
                                S. 4473

  To amend title 17, United States Code, to address circumvention of 
copyright protection systems with respect to the maintenance or repair 
      of critical medical infrastructure, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             August 6, 2020

   Mr. Wyden introduced the following bill; which was read twice and 
               referred to the Committee on the Judiciary

_______________________________________________________________________

                                 A BILL


 
  To amend title 17, United States Code, to address circumvention of 
copyright protection systems with respect to the maintenance or repair 
      of critical medical infrastructure, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Critical Medical Infrastructure 
Right-to-Repair Act of 2020''.

SEC. 2. DEFINITIONS.

    In this Act--
            (1) the term ``commerce'' has the meaning given the term in 
        section 4 of the Federal Trade Commission Act (15 U.S.C. 44);
            (2) the terms ``covered emergency'', ``covered service 
        provider'', ``critical medical infrastructure'', ``repair'', 
        and ``service material'' have the meanings given those terms in 
        section 123(a) of title 17, United States Code, as added by 
        section 3(a)(1) of this Act;
            (3) the term ``covered healthcare provider'' has the 
        meaning given the term in section 1201(l)(1) of title 17, 
        United States Code, as added by section 3(a)(2) of this Act;
            (4) the term ``critical medical infrastructure contract'' 
        means a contract relating to the purchase, leasing, licensing, 
        repair, or maintenance (including periodic maintenance) of 
        critical medical infrastructure;
            (5) the term ``service provider'' means any person engaged 
        in the diagnosis of problems with respect to, or the service, 
        maintenance, or repair of, critical medical infrastructure; and
            (6) the term ``trade secret'' has the meaning given the 
        term in section 1839 of title 18, United States Code.

SEC. 3. COPYRIGHTS.

    (a) In General.--Title 17, United States Code, is amended--
            (1) in chapter 1, by adding at the end the following:
``Sec. 123. Limitation on exclusive rights: incidental copies of 
              service materials made during maintenance or repair of 
              critical medical infrastructure
    ``(a) Definitions.--In this section--
            ``(1) the term `covered emergency' means the public health 
        emergency declared by the Secretary of Health and Human 
        Services under section 319 of the Public Health Service Act (42 
        U.S.C. 247d) on January 31, 2020, with respect to the 
        Coronavirus Disease 2019 (COVID-19), including any renewal of 
        that declaration;
            ``(2) the term `covered service provider' means--
                    ``(A) the owner or licensee of a copy of service 
                materials; or
                    ``(B) the agent of a person described in 
                subparagraph (A);
            ``(3) the term `critical medical infrastructure' means a 
        device, computer program, or other product or equipment used to 
        provide medical services;
            ``(4) the term `repair', when used with respect to critical 
        medical infrastructure, means to restore that critical medical 
        infrastructure to a state that is in accordance with the 
        original specifications of that critical medical 
        infrastructure, including any changes to those original 
        specifications that are issued by the manufacturer of the 
        critical medical infrastructure; and
            ``(5) the term `service material', when used with respect 
        to critical medical infrastructure--
                    ``(A) means any information or material that the 
                manufacturer of that infrastructure provides directly, 
                indirectly, or wirelessly to--
                            ``(i) technicians of the manufacturer; or
                            ``(ii) repair facilities that are 
                        authorized by the manufacturer; and
                    ``(B) includes--
                            ``(i) manuals, schematics, wiring diagrams, 
                        mechanical layouts, and other pertinent data 
                        with respect to that critical medical 
                        infrastructure;
                            ``(ii) computer programs used in diagnosing 
                        problems with respect to that critical medical 
                        infrastructure or in calibrating, repairing, or 
                        maintaining that critical medical 
                        infrastructure;
                            ``(iii) service keys that are required to 
                        access diagnostic information, and otherwise 
                        authorize repairs, with respect to that 
                        critical medical infrastructure;
                            ``(iv) error logs that are required to 
                        diagnose required repairs with respect to that 
                        critical medical infrastructure;
                            ``(v) preventative and corrective 
                        maintenance, inspection, and repair procedures 
                        with respect to that critical medical 
                        infrastructure;
                            ``(vi) information regarding safety alerts, 
                        recalls, service bulletins, specification 
                        updates, and the need for adjustments to 
                        maintain efficiency, safety, and convenience 
                        with respect to that critical medical 
                        infrastructure; and
                            ``(vii) any other information provided to 
                        diagnose problems with respect to, or to 
                        service, maintain, repair, activate, certify, 
                        or install, that critical medical 
                        infrastructure, including--
                                    ``(I) with respect to any 
                                replacement part or equipment relating 
                                to that piece of critical medical 
                                infrastructure; and
                                    ``(II) training materials with 
                                respect to that critical medical 
                                infrastructure.
    ``(b) Limitation.--Notwithstanding the provisions of section 106, 
it is not an infringement of copyright for a covered service provider 
to make, or to authorize the making of, a separate copy of service 
materials with respect to the covered service provider, if--
            ``(1) making that separate copy is incidental to the repair 
        or maintenance of critical medical infrastructure; and
            ``(2) the repair or maintenance described in paragraph (1) 
        is part of a response to the covered emergency.
    ``(c) Rule of Construction.--Nothing in this section may be 
construed to imply that the actions explicitly authorized under this 
section may not also be permitted under another provision of this 
title.''; and
            (2) in section 1201, by adding at the end the following:
    ``(l) Repair of Critical Medical Infrastructure Relating to COVID-
19.--
            ``(1) Definitions.--For purposes of this subsection--
                    ``(A) the terms `covered emergency', `critical 
                medical infrastructure', and `repair' have the meanings 
                given those terms in section 123(a); and
                    ``(B) the term `covered healthcare provider' 
                means--
                            ``(i) a healthcare provider who is the 
                        owner, lessee, or licensee of critical medical 
                        infrastructure; or
                            ``(ii) the agent of a person described in 
                        clause (i).
            ``(2) Permissible circumvention.--Notwithstanding the 
        provisions of subsection (a)(1)(A), it is not a violation of 
        that subsection for a covered healthcare provider to circumvent 
        a technological measure that effectively controls access to a 
        work protected under this title, if--
                    ``(A) the purpose of the act of circumvention is to 
                repair or maintain critical medical infrastructure with 
                respect to that covered healthcare provider; and
                    ``(B) the repair or maintenance described in 
                subparagraph (A) is part of preparation for, or a 
                response to, the covered emergency.
            ``(3) Enabling circumvention.--Notwithstanding the 
        provisions of subsections (a)(2) and (b), it is not a violation 
        of either such provision for a covered healthcare provider to 
        manufacture, import, offer to the public, provide, or otherwise 
        traffic in technological means to circumvent a technological 
        measure that effectively controls access to a work protected 
        under this title, or to circumvent protection afforded by a 
        technological measure that effectively controls access to a 
        work protected under this title, if that action by that covered 
        healthcare provider enables a repair or maintenance permitted 
        under paragraph (2).
            ``(4) Rules of construction.--Nothing in this subsection 
        may be construed to--
                    ``(A) exempt a covered healthcare provider from 
                compliance with any other applicable law or regulation 
                relating to the repair or maintenance of critical 
                medical infrastructure, except as explicitly provided 
                in this subsection; or
                    ``(B) prevent the Librarian of Congress from 
                determining, under the applicable subparagraphs of 
                subsection (a)(1), that subparagraph (A) of such 
                subsection (a)(1) shall not apply to a covered 
                healthcare provider relating to the circumvention of a 
                technological measure that effectively controls access 
                to a work protected under this title.''.
    (b) Technical and Conforming Amendment.--The table of sections for 
chapter 1 of title 17, United States Code, is amended by adding at the 
end the following:

``123. Limitation on exclusive rights: incidental copies of service 
                            materials made during maintenance or repair 
                            of critical medical infrastructure.''.

SEC. 4. PATENTS.

    Section 271 of title 35, United States Code, is amended--
            (1) by redesignating subsections (h) and (i) as subsections 
        (i) and (j), respectively; and
            (2) by inserting after subsection (g) the following:
    ``(h) Design Patents.--
            ``(1) Definitions.--In this subsection--
                    ``(A) the terms `covered emergency', `critical 
                medical infrastructure', and `repair' have the meanings 
                given the terms in section 123(a) of title 17; and
                    ``(B) the term `covered healthcare provider' has 
                the meaning given the term in section 1201(l) of title 
                17.
            ``(2) Non-infringement.--It shall not be an act of 
        infringement with respect to a patent for design obtained under 
        section 171 for a covered healthcare provider to fabricate a 
        part on a non-commercial basis, and as needed, for the repair 
        or maintenance of critical medical infrastructure with respect 
        to that covered healthcare provider, if the repair or 
        maintenance is part of a response to the covered emergency.
            ``(3) Rule of construction.--Nothing in this subsection may 
        be construed to exempt a covered healthcare provider from 
        compliance with any other applicable law or regulation relating 
        to a part or critical medical infrastructure described in 
        paragraph (2).''.

SEC. 5. CONTRACTS.

    Notwithstanding any other provision of law or regulation, a 
provision of a critical medical infrastructure contract is null and 
void if that provision of the critical medical infrastructure contract 
prohibits or restricts the ability of a covered healthcare provider 
that is a party to the contract to, in response to the covered 
emergency, repair or maintain critical medical infrastructure with 
respect to the covered healthcare provider.

SEC. 6. MANUFACTURER REQUIREMENTS.

    (a) Definition.--
            (1) In general.--Subject to paragraph (2), in this section, 
        the term ``fair and reasonable terms'' means, with respect to a 
        manufacturer of critical medical infrastructure, that the 
        manufacturer provides access to service materials, or offers 
        for sale a tool, with respect to the critical medical 
        infrastructure at costs and terms that are equivalent to the 
        most favorable costs and terms offered by that manufacturer to 
        repair facilities that are authorized by that manufacturer--
                    (A) using the net costs that would be incurred by 
                that repair facility in obtaining an equivalent part, 
                tool, or documentation; and
                    (B) taking into consideration any discount, rebate, 
                or other incentive offered by the manufacturer.
            (2) Documentation.--For the purposes of paragraph (1), if a 
        manufacturer described in that paragraph provides access to 
        service materials that are in the form of documentation, the 
        term ``fair and reasonable terms'' with respect to that 
        provision of access means at no charge, except that if the 
        applicable service provider requests documentation in physical 
        printed form, the term ``fair and reasonable terms'' includes a 
        charge imposed by the manufacturer for the reasonable actual 
        costs of preparing and sending the documentation.
    (b) Duty To Disclose Information.--The manufacturer of a piece of 
critical medical infrastructure sold, leased, or otherwise introduced 
into commerce in the United States shall provide owners, lessees, or 
service providers with respect to that piece of infrastructure with 
access to, on fair and reasonable terms, service materials that are 
required to--
            (1) diagnose problems with respect to that critical medical 
        infrastructure; and
            (2) service, maintain, or repair that critical medical 
        infrastructure.
    (c) Duty To Make Tools Available.--The manufacturer of critical 
medical infrastructure sold, leased, or otherwise introduced into 
commerce in the United States shall--
            (1) offer for sale to the owner or lessee of the critical 
        medical infrastructure, and to all service providers with 
        respect to the critical medical infrastructure, on fair and 
        reasonable terms, any tool (including software) for the 
        diagnosis, service, maintenance, or repair of the critical 
        medical infrastructure; and
            (2) provide all information that enables after-market tool 
        companies to manufacture tools with the same functional 
        characteristics as those tools made available by the 
        manufacturers to authorized dealers.
    (d) Equipment.--The manufacturer of critical medical infrastructure 
sold, leased, or otherwise introduced into commerce in the United 
States shall offer for sale to the owner or lessee of the critical 
medical infrastructure, and to all service providers with respect to 
the critical medical infrastructure, on fair and reasonable terms, all 
equipment for diagnosis of problems with respect to, service, 
maintenance, or repair of the critical medical infrastructure.
    (e) Protection of Trade Secrets.--
            (1) In general.--Subject to paragraph (2), a manufacturer 
        of critical medical infrastructure may not be required to 
        publicly disclose information that, if made public, would 
        divulge methods or processes entitled to protection as trade 
        secrets under chapter 90 of title 18, United States Code.
            (2) Provision of information to dealers or service 
        providers.--A manufacturer of critical medical infrastructure 
        may not withhold information under paragraph (1) on the ground 
        that disclosing the information would divulge methods or 
        processes entitled to protection as trade secrets under chapter 
        90 of title 18, United States Code, if that information is 
        provided directly or indirectly to authorized dealers or 
        service providers.
    (f) Enforcement by the Federal Trade Commission.--
            (1) Unfair or deceptive acts or practices.--A violation of 
        this section, or a regulation promulgated under this section, 
        shall be treated as a violation of a rule defining an unfair or 
        deceptive act or practice prescribed under section 18(a)(1)(B) 
        of the Federal Trade Commission Act (15 U.S.C. 57a(a)(1)(B)).
            (2) Powers of commission.--The Federal Trade Commission 
        (referred to in this subsection as the ``Commission'') shall 
        enforce this section and any regulation promulgated under this 
        section in the same manner, by the same means, and with the 
        same jurisdiction, powers, and duties as though all applicable 
        terms and provisions of the Federal Trade Commission Act (15 
        U.S.C. 41 et seq.) were incorporated into and made a part of 
        this section. Any person who violates this section or a 
        regulation promulgated under this section shall be subject to 
        the penalties and entitled to the privileges and immunities 
        provided in the Federal Trade Commission Act. Enforcement by 
        the Commission shall be the exclusive means of enforcing 
        compliance with this section and any regulation promulgated 
        under this section.
            (3) Rulemaking authority.--The Commission shall have 
        authority under section 553 of title 5, United States Code, to 
        promulgate any regulations necessary to implement this section.

SEC. 7. STUDY AND REPORT.

    (a) Study.--The Chairman of the Federal Trade Commission, in 
consultation with the Register of Copyrights and the Under Secretary of 
Commerce for Intellectual Property and Director of the United States 
Patent and Trademark Office, shall conduct a study regarding the impact 
and effectiveness of this Act, and the amendments made by this Act, 
with respect to innovation and anticompetitive practices in the market 
for critical medical infrastructure, including enforcement with respect 
to those practices.
    (b) Report to Congress.--Not later than 1 year after the date of 
enactment of this Act, the Chairman of the Federal Trade Commission 
shall--
            (1) submit to Congress a report that contains the results 
        of the study conducted under subsection (a); and
            (2) make publicly available on the website of the Federal 
        Trade Commission the report submitted under paragraph (1).
                                 <all>