Federal
Critical Medical Infrastructure Right-to-Repair Act of 2020
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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 cir-
cumvention of copyright protection systems with respect
to the maintenance or repair of critical medical infra-
structure, and for other purposes.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Critical Medical Infra-
4
structure Right-to-Repair Act of 2020’’.
5
SEC. 2. DEFINITIONS.
6
In this Act—
7
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(1) the term ‘‘commerce’’ has the meaning
1
given the term in section 4 of the Federal Trade
2
Commission Act (15 U.S.C. 44);
3
(2) the terms ‘‘covered emergency’’, ‘‘covered
4
service provider’’, ‘‘critical medical infrastructure’’,
5
‘‘repair’’, and ‘‘service material’’ have the meanings
6
given those terms in section 123(a) of title 17,
7
United States Code, as added by section 3(a)(1) of
8
this Act;
9
(3) the term ‘‘covered healthcare provider’’ has
10
the meaning given the term in section 1201(l)(1) of
11
title 17, United States Code, as added by section
12
3(a)(2) of this Act;
13
(4) the term ‘‘critical medical infrastructure
14
contract’’ means a contract relating to the purchase,
15
leasing, licensing, repair, or maintenance (including
16
periodic maintenance) of critical medical infrastruc-
17
ture;
18
(5) the term ‘‘service provider’’ means any per-
19
son engaged in the diagnosis of problems with re-
20
spect to, or the service, maintenance, or repair of,
21
critical medical infrastructure; and
22
(6) the term ‘‘trade secret’’ has the meaning
23
given the term in section 1839 of title 18, United
24
States Code.
25
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•S 4473 IS
SEC. 3. COPYRIGHTS.
1
(a) IN GENERAL.—Title 17, United States Code, is
2
amended—
3
(1) in chapter 1, by adding at the end the fol-
4
lowing:
5
‘‘§ 123. Limitation on exclusive rights: incidental cop-
6
ies of service materials made during
7
maintenance or repair of critical medical
8
infrastructure
9
‘‘(a) DEFINITIONS.—In this section—
10
‘‘(1) the term ‘covered emergency’ means the
11
public health emergency declared by the Secretary of
12
Health and Human Services under section 319 of
13
the Public Health Service Act (42 U.S.C. 247d) on
14
January 31, 2020, with respect to the Coronavirus
15
Disease 2019 (COVID–19), including any renewal of
16
that declaration;
17
‘‘(2)
the
term
‘covered
service
provider’
18
means—
19
‘‘(A) the owner or licensee of a copy of
20
service materials; or
21
‘‘(B) the agent of a person described in
22
subparagraph (A);
23
‘‘(3) the term ‘critical medical infrastructure’
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means a device, computer program, or other product
25
or equipment used to provide medical services;
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‘‘(4) the term ‘repair’, when used with respect
1
to critical medical infrastructure, means to restore
2
that critical medical infrastructure to a state that is
3
in accordance with the original specifications of that
4
critical
medical
infrastructure,
including
any
5
changes to those original specifications that are
6
issued by the manufacturer of the critical medical
7
infrastructure; and
8
‘‘(5) the term ‘service material’, when used with
9
respect to critical medical infrastructure—
10
‘‘(A) means any information or material
11
that the manufacturer of that infrastructure
12
provides directly, indirectly, or wirelessly to—
13
‘‘(i) technicians of the manufacturer;
14
or
15
‘‘(ii) repair facilities that are author-
16
ized by the manufacturer; and
17
‘‘(B) includes—
18
‘‘(i) manuals, schematics, wiring dia-
19
grams, mechanical layouts, and other per-
20
tinent data with respect to that critical
21
medical infrastructure;
22
‘‘(ii) computer programs used in diag-
23
nosing problems with respect to that crit-
24
ical medical infrastructure or in cali-
25
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brating, repairing, or maintaining that
1
critical medical infrastructure;
2
‘‘(iii) service keys that are required to
3
access diagnostic information, and other-
4
wise authorize repairs, with respect to that
5
critical medical infrastructure;
6
‘‘(iv) error logs that are required to
7
diagnose required repairs with respect to
8
that critical medical infrastructure;
9
‘‘(v) preventative and corrective main-
10
tenance, inspection, and repair procedures
11
with respect to that critical medical infra-
12
structure;
13
‘‘(vi) information regarding safety
14
alerts, recalls, service bulletins, specifica-
15
tion updates, and the need for adjustments
16
to maintain efficiency, safety, and conven-
17
ience with respect to that critical medical
18
infrastructure; and
19
‘‘(vii) any other information provided
20
to diagnose problems with respect to, or to
21
service, maintain, repair, activate, certify,
22
or install, that critical medical infrastruc-
23
ture, including—
24
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‘‘(I) with respect to any replace-
1
ment part or equipment relating to
2
that piece of critical medical infra-
3
structure; and
4
‘‘(II) training materials with re-
5
spect to that critical medical infra-
6
structure.
7
‘‘(b) LIMITATION.—Notwithstanding the provisions
8
of section 106, it is not an infringement of copyright for
9
a covered service provider to make, or to authorize the
10
making of, a separate copy of service materials with re-
11
spect to the covered service provider, if—
12
‘‘(1) making that separate copy is incidental to
13
the repair or maintenance of critical medical infra-
14
structure; and
15
‘‘(2) the repair or maintenance described in
16
paragraph (1) is part of a response to the covered
17
emergency.
18
‘‘(c) RULE OF CONSTRUCTION.—Nothing in this sec-
19
tion may be construed to imply that the actions explicitly
20
authorized under this section may not also be permitted
21
under another provision of this title.’’; and
22
(2) in section 1201, by adding at the end the
23
following:
24
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•S 4473 IS
‘‘(l) REPAIR OF CRITICAL MEDICAL INFRASTRUC-
1
TURE RELATING TO COVID–19.—
2
‘‘(1) DEFINITIONS.—For purposes of this sub-
3
section—
4
‘‘(A) the terms ‘covered emergency’, ‘crit-
5
ical medical infrastructure’, and ‘repair’ have
6
the meanings given those terms in section
7
123(a); and
8
‘‘(B) the term ‘covered healthcare provider’
9
means—
10
‘‘(i) a healthcare provider who is the
11
owner, lessee, or licensee of critical medical
12
infrastructure; or
13
‘‘(ii) the agent of a person described
14
in clause (i).
15
‘‘(2) PERMISSIBLE CIRCUMVENTION.—Notwith-
16
standing the provisions of subsection (a)(1)(A), it is
17
not a violation of that subsection for a covered
18
healthcare provider to circumvent a technological
19
measure that effectively controls access to a work
20
protected under this title, if—
21
‘‘(A) the purpose of the act of circumven-
22
tion is to repair or maintain critical medical in-
23
frastructure with respect to that covered health-
24
care provider; and
25
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‘‘(B) the repair or maintenance described
1
in subparagraph (A) is part of preparation for,
2
or a response to, the covered emergency.
3
‘‘(3)
ENABLING
CIRCUMVENTION.—Notwith-
4
standing the provisions of subsections (a)(2) and
5
(b), it is not a violation of either such provision for
6
a covered healthcare provider to manufacture, im-
7
port, offer to the public, provide, or otherwise traffic
8
in technological means to circumvent a technological
9
measure that effectively controls access to a work
10
protected under this title, or to circumvent protec-
11
tion afforded by a technological measure that effec-
12
tively controls access to a work protected under this
13
title, if that action by that covered healthcare pro-
14
vider enables a repair or maintenance permitted
15
under paragraph (2).
16
‘‘(4) RULES
OF
CONSTRUCTION.—Nothing in
17
this subsection may be construed to—
18
‘‘(A) exempt a covered healthcare provider
19
from compliance with any other applicable law
20
or regulation relating to the repair or mainte-
21
nance of critical medical infrastructure, except
22
as explicitly provided in this subsection; or
23
‘‘(B) prevent the Librarian of Congress
24
from determining, under the applicable sub-
25
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paragraphs of subsection (a)(1), that subpara-
1
graph (A) of such subsection (a)(1) shall not
2
apply to a covered healthcare provider relating
3
to the circumvention of a technological measure
4
that effectively controls access to a work pro-
5
tected under this title.’’.
6
(b) TECHNICAL AND CONFORMING AMENDMENT.—
7
The table of sections for chapter 1 of title 17, United
8
States Code, is amended by adding at the end the fol-
9
lowing:
10
‘‘123. Limitation on exclusive rights: incidental copies of service materials made
during maintenance or repair of critical medical infrastruc-
ture.’’.
SEC. 4. PATENTS.
11
Section 271 of title 35, United States Code, is
12
amended—
13
(1) by redesignating subsections (h) and (i) as
14
subsections (i) and (j), respectively; and
15
(2) by inserting after subsection (g) the fol-
16
lowing:
17
‘‘(h) DESIGN PATENTS.—
18
‘‘(1) DEFINITIONS.—In this subsection—
19
‘‘(A) the terms ‘covered emergency’, ‘crit-
20
ical medical infrastructure’, and ‘repair’ have
21
the meanings given the terms in section 123(a)
22
of title 17; and
23
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‘‘(B) the term ‘covered healthcare provider’
1
has the meaning given the term in section
2
1201(l) of title 17.
3
‘‘(2) NON-INFRINGEMENT.—It shall not be an
4
act of infringement with respect to a patent for de-
5
sign obtained under section 171 for a covered
6
healthcare provider to fabricate a part on a non-
7
commercial basis, and as needed, for the repair or
8
maintenance of critical medical infrastructure with
9
respect to that covered healthcare provider, if the re-
10
pair or maintenance is part of a response to the cov-
11
ered emergency.
12
‘‘(3) RULE
OF
CONSTRUCTION.—Nothing in
13
this subsection may be construed to exempt a cov-
14
ered healthcare provider from compliance with any
15
other applicable law or regulation relating to a part
16
or critical medical infrastructure described in para-
17
graph (2).’’.
18
SEC. 5. CONTRACTS.
19
Notwithstanding any other provision of law or regula-
20
tion, a provision of a critical medical infrastructure con-
21
tract is null and void if that provision of the critical med-
22
ical infrastructure contract prohibits or restricts the abil-
23
ity of a covered healthcare provider that is a party to the
24
contract to, in response to the covered emergency, repair
25
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or maintain critical medical infrastructure with respect to
1
the covered healthcare provider.
2
SEC. 6. MANUFACTURER REQUIREMENTS.
3
(a) DEFINITION.—
4
(1) IN GENERAL.—Subject to paragraph (2), in
5
this section, the term ‘‘fair and reasonable terms’’
6
means, with respect to a manufacturer of critical
7
medical infrastructure, that the manufacturer pro-
8
vides access to service materials, or offers for sale a
9
tool, with respect to the critical medical infrastruc-
10
ture at costs and terms that are equivalent to the
11
most favorable costs and terms offered by that man-
12
ufacturer to repair facilities that are authorized by
13
that manufacturer—
14
(A) using the net costs that would be in-
15
curred by that repair facility in obtaining an
16
equivalent part, tool, or documentation; and
17
(B) taking into consideration any discount,
18
rebate, or other incentive offered by the manu-
19
facturer.
20
(2) DOCUMENTATION.—For the purposes of
21
paragraph (1), if a manufacturer described in that
22
paragraph provides access to service materials that
23
are in the form of documentation, the term ‘‘fair
24
and reasonable terms’’ with respect to that provision
25
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of access means at no charge, except that if the ap-
1
plicable service provider requests documentation in
2
physical printed form, the term ‘‘fair and reasonable
3
terms’’ includes a charge imposed by the manufac-
4
turer for the reasonable actual costs of preparing
5
and sending the documentation.
6
(b) DUTY TO DISCLOSE INFORMATION.—The manu-
7
facturer of a piece of critical medical infrastructure sold,
8
leased, or otherwise introduced into commerce in the
9
United States shall provide owners, lessees, or service pro-
10
viders with respect to that piece of infrastructure with ac-
11
cess to, on fair and reasonable terms, service materials
12
that are required to—
13
(1) diagnose problems with respect to that crit-
14
ical medical infrastructure; and
15
(2) service, maintain, or repair that critical
16
medical infrastructure.
17
(c) DUTY TO MAKE TOOLS AVAILABLE.—The manu-
18
facturer of critical medical infrastructure sold, leased, or
19
otherwise introduced into commerce in the United States
20
shall—
21
(1) offer for sale to the owner or lessee of the
22
critical medical infrastructure, a
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