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Generative AI: A global guide to key IP considerations
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United States | Publication | outubro 2022
The Accreditation Council for Graduate Medical Education (ACGME), the national accrediting body responsible for the accreditation of institutions that sponsor graduate medical education (GME) programs and for the accreditation of those GME programs, has adopted revised accreditation standards applicable to GME programs in obstetrics and gynecology (OB-GYN), effective September 17, 2022 (the Program Requirements).1
The changes to the Program Requirements were prompted by the US Supreme Court's decision in Dobbs v. Jackson Women's Health Organization, 142 S.Ct. 2228 (2022), which overturned the Court's 1973 Roe v. Wade decision.2 In Dobbs, the Court held that the Constitution of the United States does not confer a right to an abortion (i.e. no federal constitutional right to abortion), with the result that states have primary authority to regulate the procedure. Since Dobbs, several states have adopted total or near-total bans on induced abortions,3 placing the Program Requirements and specifically the requirements pertaining to OB-GYN resident training in induced abortions, at odds with state law bans or other laws largely restricting the performance of induced abortions.
The ACGME, through its Review Committee for Obstetrics and Gynecology (the Review Committee),4 previously required and as part of the September 17, 2022 update to the Program Requirements, continues to require that ACGME-accredited OB-GYN residency programs provide "clinical experience or access to clinical experience in the provision of abortions" as part of the program's planned curriculum. New requirements state that "[i]f a program is in a jurisdiction where resident access to this clinical experience is unlawful, the program must provide access to this clinical experience in a different jurisdiction where it is lawful."5
In addition, in order to comply with the newly revised requirements, OB-GYN programs located in a jurisdiction in which abortions are unlawful, together with the institution sponsoring the program (a Sponsoring Institution), must provide "support" for the training experience. As was previously the case, residents having a religious or moral objection may continue to opt out of training or the performance of induced abortions.
The new requirements also address the management of spontaneous abortions, stating that residents "must have didactic activities and clinical experience in the comprehensive management of spontaneous abortion and pregnancy loss," including patient education, complication management and post-pregnancy loss care, adding that resident clinical experience in uterine evacuation "should" take place in a clinical setting - an operating room and/or outpatient settings.6
In a change from the proposed revisions to the Program Requirements published by the ACGME for comment this past June, the final version of the revised Program Requirements does not specifically address instances in which residents are unable to travel for abortion training. The proposed revisions previously had stated: "For programs in jurisdictions where legal restrictions on induced abortions prevent satisfaction there of the requirement for clinical experience in induced abortions," and a resident was unable to travel to another jurisdiction for the clinical experience, "the program must provide that resident with a combination of didactic activities, including simulation and assessment on performing a uterine evacuation (surgical and medical) and communicating pregnancy options."7
The ACGME offers commentary as to the newly adopted revisions to the Program Requirements in the "Background and Intent" sections of the updated requirements. The "Specialty-Specific Background and Intent" section associated with the revised Program Requirements governing training in induced abortions provides in part, that: "For decades, the obstetrics and gynecology residency Program Requirements have included the requirement that programs provide access to induced abortion training," and further, that training in abortions is "directly relevant to preserving the life and health of pregnant patients in some instances and equips residents with the skills and knowledge necessary for providing care in other reproductive health care contexts…".8
Importantly for program and institutional compliance with the revised Program Requirements, the ACGME directs that accredited OB-GYN programs "must be structured such that residents may 'opt-out' rather than needing to 'opt-in.'"9 As explained in the ACGME's commentary/philosophical statements, even if no residents participate in induced abortion training, the ACGME would consider a program with an "opt-out" curriculum to be in "substantial compliance" with the accreditation requirements.10 On the other hand, if an OB-GYN program has a curriculum that requires residents to request to participate in clinical experiences in induced abortions, a program would be considered to have an "opt-in" curriculum and the Review Committee will find those programs to be non-compliant with the Program Requirements.
Also important to OB-GYN programs and to Sponsoring Institutions located in jurisdictions in which abortions are unlawful, is ACGME guidance on required "support" for resident clinical experience in jurisdictions in which the procedure is lawful.11 According to the ACGME: "Depending on the circumstances, support may require financial, logistical, educational and/or other resources" (emphasis added).12 If a program, in partnership with its Sponsoring Institution, fails to provide support for clinical experiences in induced abortions (or penalizes residents who receive support for clinical experiences in induced abortion), the ACGME states, without addressing implications for the Sponsoring Institution, that "the program will be considered non-compliant" with the new requirement.
Despite the ACGME's "Background and Intent" information and a previously published "Summary and Impact of Interim Requirement Revisions,"13 many questions remain for OB-GYN programs and Sponsoring Institutions. One such question is whether citations for non-compliance with the revised Program Requirements will be relied upon by the ACGME to support probation or withdrawal of an OB-GYN program's accreditation or a Sponsoring Institution's accreditation. It is not yet known how certain abortion bans or restrictions will be interpreted by the courts, including issues pertaining to the reach of certain abortion bans or restrictions. A program or Sponsoring Institution may determine that supporting training in induced abortions, even if that training takes place in a jurisdiction in which the procedure is lawful, potentially violates its home state law or otherwise presents a significant risk of litigation or liability.
In Texas, for example, Attorney General Ken Paxton opined last December, prior to the Dobbs ruling, that ACGME standards that require induced abortion training are inconsistent with and conflict with federal law, specifically the Coats-Snowe Amendment14 and that, further, based on
"constitutional and religious freedom concerns" and the "conscience rights of doctors and students," a GME program "should" implement opt-in induced abortion training (emphasis added).15
Texas now also has a strict ban on induced abortions, prohibiting persons from knowingly "perform[ing], induc[ing] or attempt[ing] an abortion" from the date of fertilization to birth, with very narrow exceptions.16 A violation of that statutory ban exposes the violator to civil, professional and criminal penalties. In addition, Texas laws that pre-date its ban on abortions remain on the books in Texas, including a law that went into effect in 2021, which allow private citizens to sue anyone who, absent certain exceptions, performs or induces an abortion after a "fetal heartbeat" has been detected.17 That same law allows private citizens to sue any person who "knowingly engages in conduct that aids or abets the performance or inducement of an abortion" in violation of the law (emphasis added). Additional states, including Idaho and Oklahoma, have modeled their own statutes after the Texas law.18 For programs in Texas, the 2021 Attorney General Opinion remains in place, including the Texas Attorney General's opinion as it pertains to the ACGME's opt-out versus opt-in training requirements.
OB-GYN programs and Sponsoring Institutions in states with laws that make training in induced abortions unlawful or impractical due to restrictions must also consider the "support" required to satisfy ACGME requirements. Programs and institutions may face practical limitations, such as restrictions on the use of funding to facilitate training in elective abortions, the ability to find and structure clinical experiences in other states that satisfy ACGME requirements and obstacles in obtaining liability coverage for residents traveling out-of-state.
OB-GYN programs and Sponsoring Institutions in states in which induced abortions are permitted and which are willing to accept out-of-state trainees are also impacted by the combination of state abortion bans and the ACGME's updated OB-GYN Program Requirements. Programs and institutions may need additional infrastructure and qualified faculty to train more residents. Building out the additional facility infrastructure takes time, as does hiring and training of qualified faculty. For some facilities, it may not be feasible to train additional residents, even as the facilities are seeing an influx of additional patients.19
Members of Congress appear to be exploring how the federal government can assist OB-GYN programs and institutions experiencing an increase in demand for abortion training. A recent Congressional Research Office Insight on "Abortion Training for Medical Students and Residents" concludes that the current federal role in the substance of graduate medical education training is limited.20 The Congressional Research Office document suggests that federal grant programs, such as the grant program operated by the federal Health Resources and Services Administration's Bureau of Health Workforce to encourage training in primary care and geriatrics, "could serve as models to create new programs to expand the capacity of existing programs to absorb additional trainees….".21
In the meantime, the Review Committee is asking OB-GYN programs to inform the Review Committee on the impact of Dobbs on their programs, including changes to program family planning curricula, whether completed or planned.22 It appears reasonable to expect that the ACGME may have further enhancements or changes to its requirements, or at least additional guidance to programs, forthcoming.
Special thanks to Associates Hayley White (Washington, DC) and Jessie Johnson (Houston) for their assistance in the preparation of this content.
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