II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Critical Medical Infra5 structure Right-to-Repair Act of 2020’’. 

6 SEC. 2. DEFINITIONS. 

7 In this Act— 


kjohnson on DSK79L0C42PROD with BILLS
2 

•S 4473 IS

1 (1) the term ‘‘commerce’’ has the meaning 

2 given the term in section 4 of the Federal Trade 

3 Commission Act (15 U.S.C. 44); 

4 (2) the terms ‘‘covered emergency’’, ‘‘covered 

5 service provider’’, ‘‘critical medical infrastructure’’, 

6 ‘‘repair’’, and ‘‘service material’’ have the meanings 

7 given those terms in section 123(a) of title 17, 

8 United States Code, as added by section 3(a)(1) of 

9 this Act; 

10 (3) the term ‘‘covered healthcare provider’’ has 

11 the meaning given the term in section 1201(l)(1) of 

12 title 17, United States Code, as added by section 

13 3(a)(2) of this Act; 

14 (4) the term ‘‘critical medical infrastructure 

15 contract’’ means a contract relating to the purchase, 

16 leasing, licensing, repair, or maintenance (including 

17 periodic maintenance) of critical medical infrastruc18 ture; 

19 (5) the term ‘‘service provider’’ means any per20 son engaged in the diagnosis of problems with re21 spect to, or the service, maintenance, or repair of, 

22 critical medical infrastructure; and 

23 (6) the term ‘‘trade secret’’ has the meaning 

24 given the term in section 1839 of title 18, United 

25 States Code. 


kjohnson on DSK79L0C42PROD with BILLS
3 

•S 4473 IS

1 SEC. 3. COPYRIGHTS. 

2 (a) IN GENERAL.—Title 17, United States Code, is 

3 amended— 

4 (1) in chapter 1, by adding at the end the fol5 lowing: 

6 ‘‘§ 123. Limitation on exclusive rights: incidental cop7 ies of service materials made during 

8 maintenance or repair of critical medical 

9 infrastructure 

10 ‘‘(a) DEFINITIONS.—In this section— 

11 ‘‘(1) the term ‘covered emergency’ means the 

12 public health emergency declared by the Secretary of 

13 Health and Human Services under section 319 of 

14 the Public Health Service Act (42 U.S.C. 247d) on 

15 January 31, 2020, with respect to the Coronavirus 

16 Disease 2019 (COVID–19), including any renewal of 

17 that declaration; 

18 ‘‘(2) the term ‘covered service provider’ 

19 means— 

20 ‘‘(A) the owner or licensee of a copy of 

21 service materials; or 

22 ‘‘(B) the agent of a person described in 

23 subparagraph (A); 

24 ‘‘(3) the term ‘critical medical infrastructure’ 

25 means a device, computer program, or other product 

26 or equipment used to provide medical services; 


kjohnson on DSK79L0C42PROD with BILLS
4 

•S 4473 IS

1 ‘‘(4) the term ‘repair’, when used with respect 

2 to critical medical infrastructure, means to restore 

3 that critical medical infrastructure to a state that is 

4 in accordance with the original specifications of that 

5 critical medical infrastructure, including any 

6 changes to those original specifications that are 

7 issued by the manufacturer of the critical medical 

8 infrastructure; and 

9 ‘‘(5) the term ‘service material’, when used with 

10 respect to critical medical infrastructure— 

11 ‘‘(A) means any information or material 

12 that the manufacturer of that infrastructure 

13 provides directly, indirectly, or wirelessly to— 

14 ‘‘(i) technicians of the manufacturer; 

15 or 

16 ‘‘(ii) repair facilities that are author17 ized by the manufacturer; and 

18 ‘‘(B) includes— 

19 ‘‘(i) manuals, schematics, wiring dia20 grams, mechanical layouts, and other per21 tinent data with respect to that critical 

22 medical infrastructure; 

23 ‘‘(ii) computer programs used in diag24 nosing problems with respect to that crit25 ical medical infrastructure or in caliVerDate Sep 11 2014 03:40 Aug 23, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S4473.IS S4473

kjohnson on DSK79L0C42PROD with BILLS
5 

•S 4473 IS

1 brating, repairing, or maintaining that 

2 critical medical infrastructure; 

3 ‘‘(iii) service keys that are required to 

4 access diagnostic information, and other5 wise authorize repairs, with respect to that 

6 critical medical infrastructure; 

7 ‘‘(iv) error logs that are required to 

8 diagnose required repairs with respect to 

9 that critical medical infrastructure; 

10 ‘‘(v) preventative and corrective main11 tenance, inspection, and repair procedures 

12 with respect to that critical medical infra13 structure; 

14 ‘‘(vi) information regarding safety 

15 alerts, recalls, service bulletins, specifica16 tion updates, and the need for adjustments 

17 to maintain efficiency, safety, and conven18 ience with respect to that critical medical 

19 infrastructure; and 

20 ‘‘(vii) any other information provided 

21 to diagnose problems with respect to, or to 

22 service, maintain, repair, activate, certify, 

23 or install, that critical medical infrastruc24 ture, including— 


kjohnson on DSK79L0C42PROD with BILLS
6 

•S 4473 IS

1 ‘‘(I) with respect to any replace2 ment part or equipment relating to 

3 that piece of critical medical infra4 structure; and 

5 ‘‘(II) training materials with re6 spect to that critical medical infra7 structure. 

8 ‘‘(b) LIMITATION.—Notwithstanding the provisions 

9 of section 106, it is not an infringement of copyright for 

10 a covered service provider to make, or to authorize the 

11 making of, a separate copy of service materials with re12 spect to the covered service provider, if— 

13 ‘‘(1) making that separate copy is incidental to 

14 the repair or maintenance of critical medical infra15 structure; and 

16 ‘‘(2) the repair or maintenance described in 

17 paragraph (1) is part of a response to the covered 

18 emergency. 

19 ‘‘(c) RULE OF CONSTRUCTION.—Nothing in this sec20 tion may be construed to imply that the actions explicitly 

21 authorized under this section may not also be permitted 

22 under another provision of this title.’’; and 

23 (2) in section 1201, by adding at the end the 

24 following: 


kjohnson on DSK79L0C42PROD with BILLS
7 

•S 4473 IS

1 ‘‘(l) REPAIR OF CRITICAL MEDICAL INFRASTRUC2 TURE RELATING TO COVID–19.— 

3 ‘‘(1) DEFINITIONS.—For purposes of this sub4 section— 

5 ‘‘(A) the terms ‘covered emergency’, ‘crit6 ical medical infrastructure’, and ‘repair’ have 

7 the meanings given those terms in section 

8 123(a); and 

9 ‘‘(B) the term ‘covered healthcare provider’ 

10 means— 

11 ‘‘(i) a healthcare provider who is the 

12 owner, lessee, or licensee of critical medical 

13 infrastructure; or 

14 ‘‘(ii) the agent of a person described 

15 in clause (i). 

16 ‘‘(2) PERMISSIBLE CIRCUMVENTION.—Notwith17 standing the provisions of subsection (a)(1)(A), it is 

18 not a violation of that subsection for a covered 

19 healthcare provider to circumvent a technological 

20 measure that effectively controls access to a work 

21 protected under this title, if— 

22 ‘‘(A) the purpose of the act of circumven23 tion is to repair or maintain critical medical in24 frastructure with respect to that covered health25 care provider; and 


kjohnson on DSK79L0C42PROD with BILLS
8 

•S 4473 IS

1 ‘‘(B) the repair or maintenance described 

2 in subparagraph (A) is part of preparation for, 

3 or a response to, the covered emergency. 

4 ‘‘(3) ENABLING CIRCUMVENTION.—Notwith5 standing the provisions of subsections (a)(2) and 

6 (b), it is not a violation of either such provision for 

7 a covered healthcare provider to manufacture, im8 port, offer to the public, provide, or otherwise traffic 

9 in technological means to circumvent a technological 

10 measure that effectively controls access to a work 

11 protected under this title, or to circumvent protec12 tion afforded by a technological measure that effec13 tively controls access to a work protected under this 

14 title, if that action by that covered healthcare pro15 vider enables a repair or maintenance permitted 

16 under paragraph (2). 

17 ‘‘(4) RULES OF CONSTRUCTION.—Nothing in 

18 this subsection may be construed to— 

19 ‘‘(A) exempt a covered healthcare provider 

20 from compliance with any other applicable law 

21 or regulation relating to the repair or mainte22 nance of critical medical infrastructure, except 

23 as explicitly provided in this subsection; or 

24 ‘‘(B) prevent the Librarian of Congress 

25 from determining, under the applicable subVerDate Sep 11 2014 03:40 Aug 23, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S4473.IS S4473

kjohnson on DSK79L0C42PROD with BILLS
9 

•S 4473 IS

1 paragraphs of subsection (a)(1), that subpara2 graph (A) of such subsection (a)(1) shall not 

3 apply to a covered healthcare provider relating 

4 to the circumvention of a technological measure 

5 that effectively controls access to a work pro6 tected under this title.’’. 

7 (b) TECHNICAL AND CONFORMING AMENDMENT.— 

8 The table of sections for chapter 1 of title 17, United 

9 States Code, is amended by adding at the end the fol10 lowing: 

‘‘123. Limitation on exclusive rights: incidental copies of service materials made 

during maintenance or repair of critical medical infrastructure.’’. 

11 SEC. 4. PATENTS. 

12 Section 271 of title 35, United States Code, is 

13 amended— 

14 (1) by redesignating subsections (h) and (i) as 

15 subsections (i) and (j), respectively; and 

16 (2) by inserting after subsection (g) the fol17 lowing: 

18 ‘‘(h) DESIGN PATENTS.— 

19 ‘‘(1) DEFINITIONS.—In this subsection— 

20 ‘‘(A) the terms ‘covered emergency’, ‘crit21 ical medical infrastructure’, and ‘repair’ have 

22 the meanings given the terms in section 123(a) 

23 of title 17; and 


kjohnson on DSK79L0C42PROD with BILLS
10 

•S 4473 IS

1 ‘‘(B) the term ‘covered healthcare provider’ 

2 has the meaning given the term in section 

3 1201(l) of title 17. 

4 ‘‘(2) NON-INFRINGEMENT.—It shall not be an 

5 act of infringement with respect to a patent for de6 sign obtained under section 171 for a covered 

7 healthcare provider to fabricate a part on a non8 commercial basis, and as needed, for the repair or 

9 maintenance of critical medical infrastructure with 

10 respect to that covered healthcare provider, if the re11 pair or maintenance is part of a response to the cov12 ered emergency. 

13 ‘‘(3) RULE OF CONSTRUCTION.—Nothing in 

14 this subsection may be construed to exempt a cov15 ered healthcare provider from compliance with any 

16 other applicable law or regulation relating to a part 

17 or critical medical infrastructure described in para18 graph (2).’’. 

19 SEC. 5. CONTRACTS. 

20 Notwithstanding any other provision of law or regula21 tion, a provision of a critical medical infrastructure con22 tract is null and void if that provision of the critical med23 ical infrastructure contract prohibits or restricts the abil24 ity of a covered healthcare provider that is a party to the 

25 contract to, in response to the covered emergency, repair 


kjohnson on DSK79L0C42PROD with BILLS
11 

•S 4473 IS

1 or maintain critical medical infrastructure with respect to 

2 the covered healthcare provider. 

3 SEC. 6. MANUFACTURER REQUIREMENTS. 

4 (a) DEFINITION.— 

5 (1) IN GENERAL.—Subject to paragraph (2), in 

6 this section, the term ‘‘fair and reasonable terms’’ 

7 means, with respect to a manufacturer of critical 

8 medical infrastructure, that the manufacturer pro9 vides access to service materials, or offers for sale a 

10 tool, with respect to the critical medical infrastruc11 ture at costs and terms that are equivalent to the 

12 most favorable costs and terms offered by that man13 ufacturer to repair facilities that are authorized by 

14 that manufacturer— 

15 (A) using the net costs that would be in16 curred by that repair facility in obtaining an 

17 equivalent part, tool, or documentation; and 

18 (B) taking into consideration any discount, 

19 rebate, or other incentive offered by the manu20 facturer. 

21 (2) DOCUMENTATION.—For the purposes of 

22 paragraph (1), if a manufacturer described in that 

23 paragraph provides access to service materials that 

24 are in the form of documentation, the term ‘‘fair 

25 and reasonable terms’’ with respect to that provision 


kjohnson on DSK79L0C42PROD with BILLS
12 

•S 4473 IS

1 of access means at no charge, except that if the ap2 plicable service provider requests documentation in 

3 physical printed form, the term ‘‘fair and reasonable 

4 terms’’ includes a charge imposed by the manufac5 turer for the reasonable actual costs of preparing 

6 and sending the documentation. 

7 (b) DUTY TO DISCLOSE INFORMATION.—The manu8 facturer of a piece of critical medical infrastructure sold, 

9 leased, or otherwise introduced into commerce in the 

10 United States shall provide owners, lessees, or service pro11 viders with respect to that piece of infrastructure with ac12 cess to, on fair and reasonable terms, service materials 

13 that are required to— 

14 (1) diagnose problems with respect to that crit15 ical medical infrastructure; and 

16 (2) service, maintain, or repair that critical 

17 medical infrastructure. 

18 (c) DUTY TO MAKE TOOLS AVAILABLE.—The manu19 facturer of critical medical infrastructure sold, leased, or 

20 otherwise introduced into commerce in the United States 

21 shall— 

22 (1) offer for sale to the owner or lessee of the 

23 critical medical infrastructure, and to all service pro24 viders with respect to the critical medical infrastruc25 ture, on fair and reasonable terms, any tool (includVerDate Sep 11 2014 03:40 Aug 23, 2020 Jkt 099200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S4473.IS S4473

kjohnson on DSK79L0C42PROD with BILLS
13 

•S 4473 IS

1 ing software) for the diagnosis, service, maintenance, 

2 or repair of the critical medical infrastructure; and 

3 (2) provide all information that enables after4 market tool companies to manufacture tools with the 

5 same functional characteristics as those tools made 

6 available by the manufacturers to authorized dealers. 

7 (d) EQUIPMENT.—The manufacturer of critical med8 ical infrastructure sold, leased, or otherwise introduced 

9 into commerce in the United States shall offer for sale 

10 to the owner or lessee of the critical medical infrastruc11 ture, and to all service providers with respect to the crit12 ical medical infrastructure, on fair and reasonable terms, 

13 all equipment for diagnosis of problems with respect to, 

14 service, maintenance, or repair of the critical medical in15 frastructure. 

16 (e) PROTECTION OF TRADE SECRETS.— 

17 (1) IN GENERAL.—Subject to paragraph (2), a 

18 manufacturer of critical medical infrastructure may 

19 not be required to publicly disclose information that, 

20 if made public, would divulge methods or processes 

21 entitled to protection as trade secrets under chapter 

22 90 of title 18, United States Code. 

23 (2) PROVISION OF INFORMATION TO DEALERS

24 OR SERVICE PROVIDERS.—A manufacturer of critical 

25 medical infrastructure may not withhold information 


kjohnson on DSK79L0C42PROD with BILLS
14 

•S 4473 IS

1 under paragraph (1) on the ground that disclosing 

2 the information would divulge methods or processes 

3 entitled to protection as trade secrets under chapter 

4 90 of title 18, United States Code, if that informa5 tion is provided directly or indirectly to authorized 

6 dealers or service providers. 

7 (f) ENFORCEMENT BY THE FEDERAL TRADE COM8 MISSION.— 

9 (1) UNFAIR OR DECEPTIVE ACTS OR PRAC10 TICES.—A violation of this section, or a regulation 

11 promulgated under this section, shall be treated as 

12 a violation of a rule defining an unfair or deceptive 

13 act or practice prescribed under section 18(a)(1)(B) 

14 of the Federal Trade Commission Act (15 U.S.C. 

15 57a(a)(1)(B)). 

16 (2) POWERS OF COMMISSION.—The Federal 

17 Trade Commission (referred to in this subsection as 

18 the ‘‘Commission’’) shall enforce this section and 

19 any regulation promulgated under this section in the 

20 same manner, by the same means, and with the 

21 same jurisdiction, powers, and duties as though all 

22 applicable terms and provisions of the Federal Trade 

23 Commission Act (15 U.S.C. 41 et seq.) were incor24 porated into and made a part of this section. Any 

25 person who violates this section or a regulation proVerDate Sep 11 2014 03:40 Aug 23, 2020 Jkt 099200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S4473.IS S4473

kjohnson on DSK79L0C42PROD with BILLS
15 

•S 4473 IS

1 mulgated under this section shall be subject to the 

2 penalties and entitled to the privileges and immuni3 ties provided in the Federal Trade Commission Act. 

4 Enforcement by the Commission shall be the exclu5 sive means of enforcing compliance with this section 

6 and any regulation promulgated under this section. 

7 (3) RULEMAKING AUTHORITY.—The Commis8 sion shall have authority under section 553 of title 

9 5, United States Code, to promulgate any regula10 tions necessary to implement this section. 

11 SEC. 7. STUDY AND REPORT. 

12 (a) STUDY.—The Chairman of the Federal Trade 

13 Commission, in consultation with the Register of Copy14 rights and the Under Secretary of Commerce for Intellec15 tual Property and Director of the United States Patent 

16 and Trademark Office, shall conduct a study regarding 

17 the impact and effectiveness of this Act, and the amend18 ments made by this Act, with respect to innovation and 

19 anticompetitive practices in the market for critical medical 

20 infrastructure, including enforcement with respect to those 

21 practices. 

22 (b) REPORT TO CONGRESS.—Not later than 1 year 

23 after the date of enactment of this Act, the Chairman of 

24 the Federal Trade Commission shall— 


kjohnson on DSK79L0C42PROD with BILLS
16 

•S 4473 IS

1 (1) submit to Congress a report that contains 

2 the results of the study conducted under subsection 

3 (a); and 

4 (2) make publicly available on the website of 

5 the Federal Trade Commission the report submitted 

6 under paragraph (1). 

Æ 


kjohnson on DSK79L0C42PROD with BILLS