Add Art 27-EE §§2790 - 2799, §2803-cc, Pub Health L; amd §6530, Ed L
Establishes the "New York regenerative medicine advancement and patient protection act" to build framework for regenerative medicine and cell-based therapies; creates patient protections and disclosure requirements; authorizes limited physician use of qualifying regenerative medicine protocols; creates a regenerative medicine registry; establishes the New York regenerative medicine innovation program.
STATE OF NEW YORK
________________________________________________________________________
11301
IN ASSEMBLY
May 11, 2026
___________
Introduced by COMMITTEE ON RULES -- (at request of M. of A. Blumencranz)
-- read once and referred to the Committee on Health
AN ACT to amend the public health law and the education law, in relation
to establishing a framework for regenerative medicine and cell-based
therapies
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. This act shall be entitled the "New York regenerative medi-
2 cine advancement and patient protection act."
3 § 2. Legislative intent. The legislature hereby finds and declares
4 that:
5 1. Regenerative medicine, including cell-based and tissue-based thera-
6 pies, has significant potential to improve healing, reduce pain, restore
7 function, and advance treatment options for musculoskeletal injury,
8 wound care, degenerative conditions, and other serious diseases.
9 2. New York should lead the nation in responsible biomedical inno-
10 vation by fostering ethical, transparent, and patient-centered access to
11 regenerative medicine while maintaining robust safeguards against fraud,
12 misrepresentation, unsafe products, and unethical sourcing.
13 3. Patients deserve truthful advertising, meaningful informed consent,
14 transparent disclosure of investigational status, and protection from
15 deceptive or scientifically unsupported claims.
16 4. Physicians and health systems in New York should have a clear state
17 framework for the lawful provision of qualifying regenerative medicine
18 services consistent with federal law, professional standards, and
19 evidence-based practice.
20 5. It is the intent of the legislature to promote innovation, attract
21 research, support clinical excellence, and protect patients by creating
22 a modern regulatory structure for regenerative medicine in New York
23 state.
24 § 3. The public health law is amended by adding a new article 27-EE to
25 read as follows:
26 ARTICLE 27-EE
27 REGENERATIVE MEDICINE AND CELL-BASED THERAPIES
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD15450-01-6
A. 11301 2
1 Section 2790. Definitions.
2 2791. Authorized use of qualifying regenerative medicine proto-
3 cols.
4 2792. Product sourcing and facility requirements.
5 2793. Patient notice and informed consent.
6 2794. Advertising and representations.
7 2795. New York regenerative medicine registry.
8 2796. Material adverse event reporting.
9 2797. New York regenerative medicine innovation program.
10 2798. Rulemaking.
11 2799. Enforcement.
12 § 2790. Definitions. As used in this article:
13 1. "Regenerative medicine" means a therapeutic approach intended to
14 repair, replace, restore, or regenerate human cells, tissues, or biolog-
15 ic function, including cell-based therapies, tissue-based therapies,
16 orthobiologics, and other human cells, tissues, and cellular and
17 tissue-based products.
18 2. "Human cells, tissues, and cellular and tissue-based products" or
19 "HCT/Ps" shall have the same meaning as recognized under applicable
20 federal law and regulation, including 21 C.F.R. Part 1271, as may be
21 amended.
22 3. "Qualifying regenerative medicine protocol" means a regenerative
23 medicine treatment, procedure, or protocol that:
24 a. is within the lawful scope of practice of a physician licensed
25 under article one hundred thirty-one of the education law;
26 b. is performed in a hospital, diagnostic and treatment center, ambu-
27 latory surgery center, or physician office authorized by law;
28 c. uses only a product, biologic, tissue, or HCT/P that is sourced,
29 manufactured, processed, stored, and transferred in compliance with
30 applicable federal law;
31 d. is accompanied by the disclosures and informed consent required by
32 this article; and
33 e. is not expressly prohibited by federal law.
34 4. "Physician" means a physician licensed pursuant to article one
35 hundred thirty-one of the education law.
36 5. "Department" means the department of health.
37 6. "Registry" means the New York regenerative medicine registry estab-
38 lished pursuant to section twenty-seven hundred ninety-five of this
39 article.
40 7. "Material adverse event" means death, hospitalization, persistent
41 or significant disability, congenital anomaly, life-threatening event,
42 serious infection, tumor formation, blindness, or any other event desig-
43 nated by the commissioner by regulation.
44 8. "Ethically sourced" means not derived from tissue obtained through
45 an abortion procedure and otherwise procured in compliance with applica-
46 ble state and federal law.
47 § 2791. Authorized use of qualifying regenerative medicine protocols.
48 1. A physician may perform or order a qualifying regenerative medicine
49 protocol in New York state, provided that all requirements of this arti-
50 cle and all applicable federal laws and regulations are satisfied.
51 2. Nothing in this article shall be construed to:
52 a. deem any product approved, licensed, or cleared by the United
53 States food and drug administration if it has not been so approved,
54 licensed, or cleared;
55 b. authorize conduct prohibited by federal law;
A. 11301 3
1 c. limit the authority of the state board for professional medical
2 conduct; or
3 d. permit false, misleading, or deceptive advertising or claims of
4 efficacy unsupported by competent scientific evidence.
5 3. Qualifying regenerative medicine protocols may include, but need
6 not be limited to, protocols related to orthopedics, sports medicine,
7 wound care, pain management, cartilage restoration, tendon and ligament
8 injury, and other indications determined by the commissioner by regu-
9 lation, provided such protocols comply with this article.
10 § 2792. Product sourcing and facility requirements. 1. A physician
11 shall not use a regenerative medicine product or protocol under this
12 article unless the underlying product or material, where applicable:
13 a. is retrieved, processed, manufactured, stored, and distributed by
14 an establishment registered with the United States food and drug admin-
15 istration when such registration is required by federal law;
16 b. is handled in accordance with applicable current good tissue prac-
17 tice, current good manufacturing practice, and other applicable federal
18 quality standards;
19 c. is accompanied by sufficient documentation to identify the source
20 establishment, chain of custody, lot information where applicable, expi-
21 ration information where applicable, and any limitations, warnings, or
22 contraindications; and
23 d. is ethically sourced.
24 2. Where an accreditation or certification exists for the source
25 establishment, tissue bank, or related facility, the physician shall
26 maintain documentation of such accreditation or certification in the
27 patient record or related compliance file.
28 3. The commissioner may by regulation establish additional documenta-
29 tion, recordkeeping, and verification requirements to protect patient
30 safety and ensure traceability.
31 § 2793. Patient notice and informed consent. 1. Before furnishing a
32 qualifying regenerative medicine protocol that involves a product,
33 biologic, or protocol that has not been approved, licensed, or cleared
34 by the United States food and drug administration for the specific indi-
35 cation for which it is being offered, the physician shall obtain written
36 informed consent signed by the patient or the patient's lawful represen-
37 tative.
38 2. Such informed consent shall be written in plain language and shall
39 include, at a minimum:
40 a. the nature and purpose of the proposed treatment;
41 b. whether the product or protocol is approved, licensed, cleared,
42 investigational, off-label, or otherwise not approved by the United
43 States food and drug administration for the specific indication at
44 issue;
45 c. the reasonably anticipated benefits, if any;
46 d. the known material risks, complications, and side effects;
47 e. reasonably available alternative treatments, including no treat-
48 ment;
49 f. a statement that outcomes cannot be guaranteed;
50 g. a statement advising the patient to consult with the patient's
51 primary care physician or treating specialist, where appropriate;
52 h. an estimate of the patient's expected financial responsibility,
53 including whether the treatment is likely not covered by insurance; and
54 i. any other information required by the commissioner. The physician
55 shall provide the patient a copy of the signed informed consent.
A. 11301 4
1 § 2794. Advertising and representations. 1. A physician, practice,
2 clinic, or facility advertising regenerative medicine services shall not
3 make any false, misleading, deceptive, or unsubstantiated claim.
4 2. Any advertisement for a regenerative medicine protocol that
5 involves a product or indication not approved, licensed, or cleared by
6 the United States food and drug administration shall include a clear and
7 conspicuous notice stating:
8 "NOTICE REQUIRED BY NEW YORK LAW: This practice offers one or more
9 regenerative medicine treatments that may not be approved, licensed, or
10 cleared by the United States Food and Drug Administration for the
11 specific condition being treated. Patients are encouraged to consult
12 with their primary care provider or treating specialist before undergo-
13 ing treatment."
14 3. Such notice shall be clearly legible and, in printed or digital
15 advertising, shall appear in a type size and placement reasonably likely
16 to be seen by an ordinary consumer.
17 4. No person shall advertise any regenerative medicine treatment as a
18 cure unless such claim is supported by competent and reliable scientific
19 evidence and is otherwise lawful.
20 § 2795. New York regenerative medicine registry. 1. The department
21 shall establish or designate a secure statewide regenerative medicine
22 registry.
23 2. Every physician or facility providing a qualifying regenerative
24 medicine protocol under this article shall report, in a manner deter-
25 mined by the commissioner:
26 a. the type of protocol performed;
27 b. the indication treated;
28 c. the type and source of product used, where applicable;
29 d. basic patient demographic information in de-identified form;
30 e. outcome measures designated by the commissioner; and
31 f. any material adverse event.
32 3. Data reported to the registry shall be de-identified to the fullest
33 extent required by law and used for quality improvement, safety monitor-
34 ing, public health analysis, and annual reporting.
35 4. The department shall publish an annual report summarizing utiliza-
36 tion, safety signals, adverse events, and policy recommendations, except
37 that no individually identifiable patient information shall be
38 disclosed.
39 § 2796. Material adverse event reporting. 1. A physician or facility
40 providing a qualifying regenerative medicine protocol shall report any
41 material adverse event to the department within seven calendar days of
42 learning of the event, or within twenty-four hours where the event
43 results in death or poses an immediate threat to public health.
44 2. Reporting under this section shall not relieve any person of any
45 separate federal reporting obligations.
46 § 2797. New York regenerative medicine innovation program. 1. There
47 is hereby established within the department, in consultation with the
48 empire state development corporation and the department of education, a
49 regenerative medicine innovation program to:
50 a. promote New York as a national center for regenerative medicine
51 research, manufacturing, and clinical excellence;
52 b. encourage collaborations among academic medical centers, community
53 hospitals, licensed physicians, biotechnology companies, and tissue
54 banks;
55 c. support translational research, workforce development, and respon-
56 sible commercialization;
A. 11301 5
1 d. identify barriers in state law or regulation that impede ethical
2 regenerative medicine innovation; and
3 e. recommend pathways to accelerate patient access consistent with
4 federal law.
5 2. Subject to appropriation, the department may designate centers of
6 regenerative medicine excellence at eligible institutions in New York
7 state.
8 3. The department shall convene an advisory council consisting of
9 physicians, scientists, bioethicists, patient advocates, manufacturers,
10 and regulatory experts to advise on implementation of this article.
11 § 2798. Rulemaking. The commissioner may promulgate rules and regu-
12 lations necessary to implement this article, including rules governing
13 documentation, registry reporting, patient notice, advertising stand-
14 ards, adverse event reporting, and additional qualifying indications.
15 § 2799. Enforcement. 1. A violation of this article, or any regulation
16 promulgated thereunder, may constitute professional misconduct, unpro-
17 fessional conduct, or other sanctionable conduct as applicable.
18 2. The department, attorney general, and any other agency with lawful
19 jurisdiction may enforce this article.
20 3. In addition to any other remedy provided by law, the commissioner
21 may assess civil penalties not to exceed ten thousand dollars for each
22 knowing violation of sections twenty-seven hundred ninety-three, twen-
23 ty-seven hundred ninety-four, twenty-seven hundred ninety-five, or twen-
24 ty-seven hundred ninety-six of this article.
25 4. Any person who knowingly falsifies registry data, conceals a mate-
26 rial adverse event, or knowingly advertises a regenerative medicine
27 treatment through materially false or fraudulent claims shall be guilty
28 of a misdemeanor.
29 § 4. Section 6530 of the education law is amended by adding a new
30 subdivision 52 to read as follows:
31 52. Practicing or advertising regenerative medicine in violation of
32 article twenty-seven-EE of the public health law, including failure to
33 obtain required informed consent, material misrepresentation of regula-
34 tory status, failure to report a material adverse event, or use of a
35 product knowingly sourced in violation of such article.
36 § 5. The public health law is amended by adding a new section 2803-cc
37 to read as follows:
38 § 2803-cc. Regenerative medicine policies in licensed facilities.
39 Every hospital, ambulatory surgery center, and diagnostic and treatment
40 center offering regenerative medicine services shall adopt written poli-
41 cies governing credentialing, patient selection, informed consent,
42 adverse event review, and compliance with article twenty-seven-EE of
43 this chapter.
44 § 6. Severability. If any clause, sentence, paragraph, section, or
45 part of this act shall be adjudged invalid by any court of competent
46 jurisdiction, such judgment shall not affect, impair, or invalidate the
47 remainder thereof.
48 § 7. This act shall take effect on the one hundred eightieth day after
49 it shall have become a law. The commissioner of health is authorized to
50 promulgate any rules and regulations necessary for the timely implemen-
51 tation of this act on or before such date.
