Certificate of Need Laws in Health Care: Past, Present, and Future.

Certificate of need (CON) laws limit the supply of health care services in about two-thirds of U.S. states. The regulations require those who wish to offer new services or expand existing services to first prove to a regulator that the care is needed. While advocates for the regulation have offered several rationales for its continuance, the balance of evidence suggests that the rules protect incumbent providers from competition at the expense of patients, payors, and would-be competitors. In this article, I review the history of CON laws in health care, summarize the large literature evaluating them, and briefly sketch options for reform.JEL Classification: I11, I18, H75.

State Regulation of Ensuring the Quality Medical Care During Martial Law in Ukraine: Lessons for the International Community.

Background: Nowadays, the quality of medical care and health care measures is considered the main target function of the health care system and at the same time the determining criterion for its activities. Objective: The article examines state regulation of medical care quality post- COVID and during martial law, identifying improvement areas. It emphasizes state roles in healthcare standardization, continuous feedback monitoring, and studying patient satisfaction. Interrelationships among Ukraine's state regulation mechanisms are determined, highlighting the need to enhance tools such as criteria and quality indicators for medical care assurance. Methods: The authors of this article utilize various scientific methods, including analysis, synthesis, induction, and deduction, as well as historical and legal, formal legal, and comparative legal methods to examine the state regulation of ensuring the quality of medical care during martial law in Ukraine. Results: The article considered the interrelationships of mechanisms and instruments of state regulation of quality assurance of medical care in Ukraine. Conclusions: The state should enhance medical care quality regulation, drawing on international experiences from the EU and the USA and adapting best practices to national circumstances. The resilience of the healthcare system depends on effective quality assurance, ensuring preparedness, stability, and ongoing improvement prospects.

International Standards and Features of Financing in the Field of Health Care and Provision of Medical Services.

The relevance of this article is due to the fact that international standards in the field of health care and medical services are central to the field of world principles of functioning and development of medical law. The aim of the article is to conduct research on the peculiarities of international standards in the field of health care and medical services, as well as to study the prospects of their implementation in Ukraine. Leading research methods are general and special research methods, including methods of logic, analysis, comparison. The results of this study are to outline recommendations for the use of international standards in the field of health care and medical services in Ukraine and to summarize the legal framework on this issue. The significance of the results is reflected in the fact that this study can serve as a basis for outlining future changes in current legislation of Ukraine on the functioning of the health care system and implementation of world practices in health care. Within the framework of this study, systematized the main international and European documents that reflect the main international standards in the field of health care and medical services and ratified in Ukraine and have a direct impact on the legal framework for this area.

Romania's Pioneering Law: Establishing the Right to Personalized Medicine.

This analysis and commentary discuss Romania's landmark law, the first globally, acknowledging the right of citizens and patients to personalized medicine. Initiated following the EU Council's 2015 policy on personalized medicine, the law is a result of intersectoral collaborative efforts led by the Centre for Innovation in Medicine in Romania using a quadruple (later evolved to penta) helix model involving academia, public, private, and civil society sectors. Promulgated on May 24, 2023, the law legally entitles patients to personalized health care and in ways informed by individual genetic and phenotypic consideration. The law mandates informed consent for medical interventions and ensures data protection in accordance with the General Data Protection Regulation. We suggest that this pioneering legislation paves the way for integrating personalized medicine into Romania's health care system, shaping clinical practice, research, and health policy. In all, it marks a significant step in redefining health care delivery, emphasizing individualized treatment and the political determinants of personalized medicine, and setting a precedent for future health care innovations worldwide.

Addressing a Human Rights Crisis: Health Care for Prisoners in Australia.

People are sent to prison as punishment and not to experience additional punishment. Nevertheless, this principle is habitually violated in Australia: prisoners frequently receive health care that is inferior to health care that is available in the general community. Numerous official inquiries have identified deficiencies in prisoner health services, notwithstanding the apparent intention of legislative provisions and non-statutory guidelines and policies in various jurisdictions to ensure prisoners receive appropriate health care. This article proposes law reforms to address this human rights crisis. It recommends the passage of uniform legislation in all Australian jurisdictions that stipulates minimum prison health care service standards, as well as mechanisms for ensuring they are implemented. The article also suggests that, in the short-term, until prison health care is significantly improved, substandard health care for prisoners should be treated as a potentially mitigating sentencing factor that can reduce the length of a defendant's prison term.

Comparative study on informed consent regulation in health care among Italy, France, United Kingdom, Nordic Countries, Germany, and Spain.

The information and subsequent expression of will, so-called informed consent, have become the essential element of health right, understood as the right to autonomous choice in health, based on the fiduciary relationship between physician and patient. This gradually leads European Countries to adopt special legislations and to issue frequent judgments on the subject. However, new challenges in daily clinical practice call for further study of legal solutions. The authors analyse and compare the regulations on informed consent in health care of Italy, France, the United Kingdom, the Nordic Countries, Germany, and Spain. The health and legal contexts, existence of special regulations on informed consent and their characteristics are discussed. Informed consent resulted a mandatory requirement. Clear communication about treatment, therapeutic alternatives, and major risks, discussed in conversation, but preferably documented in writing, are agreed upon. The possibility of dissent and withdrawal of consent are also included. There is a growing interest in involving and regulating the entire health team in information and consent. Lowering the age of consent for minors or analysing the maturity of minors are attempts to increase their participation in health decisions. On another side, the protection of adult incapables persons requires greater involvement of family and fiduciaries to better adapt to changing health needs. Health policy must take responsibility for training health professionals and citizens about the value of health information and communication as a shared choice in care planning, to strengthen the bond of trust with the healthcare system and users.

Health Care AI and Patient Privacy-Dinerstein v Google.

This Viewpoint summarizes a recent lawsuit alleging that a hospital violated patients' privacy by sharing electronic health record (EHR) data with Google for development of medical artificial intelligence (AI) and discusses how the federal court's decision in the case provides key insights for hospitals planning to share EHR data with for-profit companies developing medical AI.

President Biden's Executive Order on Artificial Intelligence-Implications for Health Care Organizations.

This Viewpoint discusses a recent executive order by US President Joe Biden about the development and implementation of AI, including the role of government vs the private sector and how the order may affect health care.

The Supreme Court's 303 Creative Decision and the Threat to LGBTQ+ Health Care.

This Viewpoint examines the importance of the Supreme Court decision in 303 Creative and its possible effects on legislation safeguarding nondiscriminatory health care.

The End of the X-waiver: Excitement, Apprehension, and Opportunity.

With the passage of the MAT act (Mainstreaming Addiction Treatment) and the MATE Act (Medication Training and Expansion), the Drug Enforcement Agency "X-waiver" program governing the office-based prescription of buprenorphine for opioid use disorder has been immediately eliminated. The move was championed by vocal organizations with a rightful concern about buprenorphine access but was opposed by most physicians. Nonetheless, buprenorphine can now be prescribed like any schedule 3 medication. Studies show that despite rising opioid overdoses, buprenorphine prescription increases have been slow to rise and are particularly absent in rural communities. The elimination of the X-waiver may theoretically improve buprenorphine prescribing rates for opioid use disorder in rural areas, by nurse practitioners and physician assistants, and by resident physicians in teaching programs. It may also help decrease discrimination against individuals with opioid use disorder in postacute-care settings like nursing homes, physical rehabilitation centers, and in prisons and jails. Concerns include the elimination of the only focused opioid use disorder education many physicians receive (X-waiver courses) and a literature base showing that interest, rather than the X-waiver itself, remains the biggest barrier to recruiting more buprenorphine prescribers. Concerns also exist over the harms of precipitated withdrawal when buprenorphine is initiated inappropriately. The change of the elimination of the X-waiver brings about a new opportunity for Family Medicine and its parent organizations to champion the inclusion of opioid use disorder treatment within the chronic disease care models well-known to our integrated care settings.

Affirmative Action Ruled Unconstitutional: Options for Building a Diverse Health Care Workforce.

This Viewpoint reviews how the recent US Supreme Court decision regarding affirmative action affects extant medical school admission policies seeking to enhance diversity of the national medical student body and its derivative national health care workforce.

Generative AI in Health Care and Liability Risks for Physicians and Safety Concerns for Patients.

This Viewpoint discusses the potential use of generative artificial intelligence (AI) in medical care and the liability risks for physicians using the technology, as well as offers suggestions for safeguards to protect patients.

How the SCOTUS Affirmative Action Ruling Could Affect Medical Schools and Health Care.

This Medical News feature examines the potential impact of the US Supreme Court's affirmative action decision on medical schools and health care.

Providing Responsible Health Care for Out-of-State Patients.

This Viewpoint discusses why the legality of calling patients located in another state has suddenly been called into question.

As Laws Restricting Health Care Surge, Some US Physicians Choose Between Fight or Flight.

In this Medical News article, 13 physicians and health care experts spoke with JAMA about the increasing efforts to criminalize evidence-based medical care in the US.

A Policy Framework for the Growing Influence of Private Equity in Health Care Delivery.

This Viewpoint details how and why improved oversight of private equity acquisition of physician practices and hospitals is needed to mitigate the effects on health care costs, clinicians' jobs, and patients' access to care.