Assessing the impact of the Physician Payments Sunshine Act on pharmaceutical companies' payments to physicians.

Enacted in 2010 as part of the Affordable Care Act, the Physician Payments Sunshine Act (PPSA) mandates transparency in financial interactions between pharmaceutical companies and healthcare providers. This study investigates the PPSA's effectiveness and its impact on industry payments to physicians. Utilizing ProPublica and Open Payments databases, a difference-in-difference analysis was conducted across ten states. Results reveal a significant reduction in pharmaceutical companies' meal-related payments post-PPSA, impacting both the total payment amount and the number of unique physicians reached. Conversely, travel payments showed no significant impact in the primary analysis. However, subsequent analyses revealed nuanced reductions in the number of unique physicians reached, highlighting a more intricate relationship wherein pharmaceutical companies likely adjusted their financial interaction strategies with physicians differently across states. State-level variations in meals further underscore the complexity of PPSA's influence. This pioneering research contributes valuable empirical evidence, addressing gaps in prior studies and emphasizing the ongoing need for policy assessment to guide industry-physician relationships.

New Reproductive Privacy Rule to Protect Both Patients and Physicians.

This Viewpoint describes the newly finalized Reproductive Privacy Rule, a HIPAA regulatory update intended to prevent law enforcement in abortion-restrictive states from obtaining reproductive care medical records to prosecute patients and physicians.

When Parents Request Nondisclosure: Rights of Adolescents to Access Their Health Information and Implications of the 21st Century Cures Act Final Rule.

AbstractDespite broad ethical consensus supporting developmentally appropriate disclosure of health information to older children and adolescents, cases in which parents and caregivers request nondisclosure continue to pose moral dilemmas for clinicians. State laws vary considerably regarding adolescents' rights to autonomy, privacy, and confidentiality, with many states not specifically addressing adolescents' right to their own healthcare information. The requirements of the 21st Century Cures Act have raised important ethical concerns for pediatricians and adolescent healthcare professionals regarding the protection of adolescent privacy and confidentiality, given requirements that chart notes and results be made readily available to patients via electronic portals. Less addressed have been the implications of the act for adolescents' access to their health information, since many healthcare systems' electronic portals are available to patients beginning at age 12, sometimes requiring that the patients themselves authorize their parents' access to the same information. In this article, we present a challenging case of protracted disagreement about an adolescent's right to honest information regarding his devastating prognosis. We then review the legal framework governing adolescents' rights to their own healthcare information, the limitations of ethics consultation to resolve such disputes, and the potential for the Cures Act's impact on electronic medical record systems to provide one form of resolution. We conclude that although parents in cases like the one presented here have the legal right to consent to medical treatment on their children's behalf, they do not have a corresponding right to direct the withholding of medical information from the patient.

The effect of following best practice reporting recommendations on legal and community evaluations of forensic examiners reports.

Commentators have recommended that forensic scientists' reports contain various disclosures to facilitate comprehension. However, little research has explored whether following best practice recommendations for disclosure impacts on receivers' impressions of the evidence. We examined whether forensic science reports that are more compliant with these best practice recommendations reduced overvaluing of the evidence and sensitized legal and community decision-makers to evidence quality. Across three experiments, 240 legal practitioners/trainees and 566 community decision-makers were presented with a fingerprint or footwear report that was either compliant or non-compliant with best practice recommendations. Participants were then asked to make evaluations and decisions based on the report. We found mixed effects of report compliance. Report compliance affected community participant's evaluations of the persuasiveness of the evidence but had limited impact on the judgments of legal practitioners/trainees. When presented with compliant reports, we found that community participants regarded unknown reliability evidence as less reliable and less persuasive than high reliability evidence, suggesting disclosures helped reduce overvaluing of the evidence and create sensitivity to differences in evidence quality. These results suggest compliance with reporting recommendations does affect community impressions, while only minimally influencing legal impressions of forensic science evidence. The costs and/or benefits of this outcome require further examination.

The Opioid Industry Documents Archive: Advancing Public Health Through Industry Document Disclosure.

More than twenty-five years after the first signs of potential harm, the US remains locked in the grip of an opioid epidemic, with more Americans dying from overdoses than ever before.1 Diversion of prescription opioids plays an important role in opioid-related harms. Much of the scientific and public health focus on diversion has been on end-users, given how commonly non-medical prescription opioid use occurs, as well as the proportion of individuals who report that their source of non-medical opioids was friends or family. However, diversion of opioids, as well as their rampant oversupply, can be discerned higher up the supply chain, including among wholesalers, pharmacies and rogue prescribers whose behavior may trigger well-described "flags" warranting further evaluation and action.

Recommendations of the Polish-speaking Working Group of the International Society for Forensic Genetics (ISFG-PL) regarding the disclosure of biological traces and the handling of evidence for identification tests. / Zalecenia Polskojezycznej Grupy Miedzynarodowego Towarzystwa Genetyki Sadowej (ISFG-PL) dotyczace ujawniania i identyfikacji sladów biologicznych przeznaczonych do badan genetycznych.

The purpose of this paper is to formulate recommendations for the disclosure of biological traces in the laboratory and the handling of forensic evidence submitted for identification tests, recommended by the Polish Speaking Working Group of the International Society for Forensic Genetics. The paper organizes the knowledge of the most relevant stages of preliminary analysis of biological traces based on both literature sources and those resulting from years of research practice. Recommendations formulated in the course of multi-stage expert consultations contained in this study should be used in the development of laboratory procedures applied during the execution.

Clinician perspectives on policy approaches to genetic risk disclosure in families.

Genomic sequencing has emerged as a powerful tool with significant implications for patients and their relatives, however, empirical evidence suggests that effective dissemination of risk information within families remains a challenge. Policy responses to address this issue vary across countries, with Belgium notably lacking specific regulations governing nondisclosure of genetic risk. In this study, we conducted semi-structured interviews with clinicians from Belgian clinical genetics centers to gain insight into their perspectives on policy approaches to the disclosure of genetic risk within families. Using real-world examples of legislation and court rulings from France, Australia, and the UK, we explored clinician viewpoints on the roles and responsibilities of both patients and clinicians in the family communication process. Clinicians expressed confusion regarding what was legally permissible regarding contacting at-risk relatives. While there was a consensus among participants that patients have a responsibility to inform their at-risk relatives, participants were hesitant to support the legal enforcement of this duty. Clinicians mostly recognized some responsibility to at-risk relatives, but the extent of this responsibility was a subject of division. Our findings highlight the need for a comprehensive policy that clarifies the roles and responsibilities of clinicians and patients to inform at-risk relatives. Furthermore, the study underscores the practical challenges clinicians face in supporting patients through the complex process of family communication, suggesting a need for additional resources and the exploration of alternative approaches to communication.

Balancing Data Provision and Data Protection: A Natural Experiment With HIV and Syphilis Surveillance Data in the United States.

BACKGROUND: Public release of health data typically requires statistical disclosure limitation (SDL), but scant research demonstrates how real-world SDL affects data usability. Recent changes of federal data re-release policy allow a pseudo-counterfactual comparison of HIV and syphilis data suppression rules. METHODS: Incident counts (2019) of HIV and syphilis infections by county for Black and White populations were downloaded from the US Centers for Disease Control and Prevention. We quantified and compared suppression status by disease and county between Black and White populations and calculated incident rate ratios for counties with statistically reliable counts. RESULTS: Approximately 50% of US counties have incident HIV counts suppressed for Black and White populations compared with only 5% for syphilis, which has an alternative suppression strategy. The county population sizes protected by a numerator disclosure rule (<4) spans several orders of magnitude. Calculations of incident rate ratios, used as a measure of health disparity, were impossible in the 220 counties most susceptible to an HIV outbreak. CONCLUSIONS: Balancing tradeoffs between providing and protecting data are key to health initiatives worldwide. We encourage an increase in empirical research on the impact of SDL, especially in the context of health disparities, and recommend new approaches to avoid the "oppression of data suppression."

Physicians' legal duty to disclose more cost-effective treatment options: an examination of Australian civil law applied to personal importation.

Objective A significant proportion of Australians defer or do not fill prescriptions they require due to cost. This article explores whether, and under what circumstances, physicians have a duty to assist these patients by disclosing how they can access more affordable medicines via personal importation. Methods This study involved a critical examination of Australian statutory and case law pertaining to physicians' duty to disclose material information to identify key principles applicable to the context of cost-motivated personal importation. Results There are several legal principles that suggest that physicians have a duty to advise patients of options for accessing more affordable medicines, including via personal importation. These include a duty to warn of inherent and non-inherent risks, a duty to disclose treatments that offer clear advantages, and a duty to facilitate access to the means for achieving patients' health goals. However, it is unclear whether, and on what grounds, responsibility for harm arising from a patient's inability to afford prescribed medicines should be attributed to the prescribing physician. Arguments supporting attribution of such a responsibility are proposed to motivate further legal, policy and ethical debate. Conclusions Physicians have a duty to take reasonable steps to mitigate foreseeable harm to their patients, however the law is silent on whether this duty extends to taking steps to help patients access medicines that they can afford. This investigation provides a framework to guide the development of sound policy and law on informed financial consent and economically motivated prescribing.

Does environmental, social, and governance performance mitigate earnings management practices? Evidence from US commercial banks.

Environmental, social, and governance (ESG) performance has attracted debates of regulatory bodies and the academic community. Previous studies highlighted the relationship between corporate social responsibility (CSR) disclosure index and earnings management (EM) for non-financial firms. In this paper, we examine the relationship between the ESG performance and EM practices for a sample of US commercial banks over the period 2010-2019. We use two proxies for earnings management: abnormal loan loss provisions (ALLP) and EM to meet the threshold of reporting small positive profit or avoiding losses (SPOS). Consistent with the transparent financial reporting hypothesis, we find that banks reporting higher ESG performance are less likely engaged in income-increasing practice through ALLP. However, no evidence supports that ESG score mitigates EM through loss avoidance. Furthermore, we disaggregate the ESG score into its main three components: environmental, social, and governance. Our findings show that the governance pillar effectively mitigates EM practice under its two proxies. Specifically, the social pillar also seems to be an efficient constraint of banks' EM through income-increasing abnormal loan loss provisions and loss avoidance activity. However, no supporting evidence of a mitigating role for the environmental pillar is provided. Taken together, our results show that, except the environmental pillar, ESG performance score acts as an efficient mitigating tool for EM practices for US banks. Our findings provide a better understanding of banks' earnings management practices. Our findings are helpful for managers when undertaking long-term investment strategies in ESG reporting practices, regulators when issuing new standards, and banks' stakeholders when assessing both the financial and non-financial performance of such entities.

The benefits and harms of open notes in mental health: A Delphi survey of international experts.

IMPORTANCE: As of April 5, 2021, as part of the 21st Century Cures Act, new federal rules in the U.S. mandate that providers offer patients access to their online clinical records. OBJECTIVE: To solicit the view of an international panel of experts on the effects on mental health patients, including possible benefits and harms, of accessing their clinical notes. DESIGN: An online 3-round Delphi poll. SETTING: Online. PARTICIPANTS: International experts identified as clinicians, chief medical information officers, patient advocates, and informaticians with extensive experience and/or research knowledge about patient access to mental health notes. MAIN OUTCOMES, AND MEASURES: An expert-generated consensus on the benefits and risks of sharing mental health notes with patients. RESULTS: A total of 70 of 92 (76%) experts from 6 countries responded to Round 1. A qualitative review of responses yielded 88 distinct items: 42 potential benefits, and 48 potential harms. A total of 56 of 70 (80%) experts responded to Round 2, and 52 of 56 (93%) responded to Round 3. Consensus was reached on 65 of 88 (74%) of survey items. There was consensus that offering online access to mental health notes could enhance patients' understanding about their diagnosis, care plan, and rationale for treatments, and that access could enhance patient recall and sense of empowerment. Experts also agreed that blocking mental health notes could lead to greater harms including increased feelings of stigmatization. However, panelists predicted there could be an increase in patients demanding changes to their clinical notes, and that mental health clinicians would be less detailed/accurate in documentation. CONCLUSIONS AND RELEVANCE: This iterative process of survey responses and ratings yielded consensus that there would be multiple benefits and few harms to patients from accessing their mental health notes. Questions remain about the impact of open notes on professional autonomy, and further empirical work into this practice innovation is warranted.

Must Consent Be Informed? Patient rights, state authority, and the moral basis of the physician's duties of disclosure.

Legal standards of disclosure in a variety of jurisdictions require physicians to inform patients about the likely consequences of treatment, as a condition for obtaining the patient's consent. Such a duty to inform is special insofar as extensive disclosure of risks and potential benefits is not usually a condition for obtaining consent in non-medical transactions.What could morally justify the physician's special legal duty to inform? I argue that existing justifications have tried but failed to ground such special duties directly in basic and general rights, such as autonomy rights. As an alternative to such direct justifications, I develop an indirect justification of physicians' special duties from an argument in Kant's political philosophy. Kant argues that pre-legal rights to freedom are the source of a duty to form a state. The state has the authority to conclusively determine what counts as "consent" in various kinds of transactions. The Kantian account can subsequently indirectly justify at least one legal standard imposing a duty to inform, the reasonable person standard, but rules out one interpretation of a competitor, the subjective standard.

Signalling Standards for Progress: Bridging the Divide Between a Valid Consent to Use Patient Data Under Data Protection Law and the Common Law Duty of Confidentiality.

In this article, we analyse the legal components of disclosing confidential patient information under the UK's common law duty of confidentiality (CLDoC) and processing personal (health) data under the UK's General Data Protection Regulation (GDPR) and Data Protection Act 2018. We describe the ostensible divide between the CLDoC and data protection law when it comes to the requirements of a valid signal of consent by a patient to use and disclose patient information, obtained by a health professional in the context of direct care, for health care and health research purposes. Ultimately, our analysis suggests that we are saddled, at least in the medium term, with two regimes operating with different standards of a valid consent-while putatively protecting similar interests. There is, however, opportunity for progress. It is possible to improve professional guidance on the interaction between the regimes and to achieve significant normative alignment without aligning the signalling standard for consent; this would promote consistent protection of reasonable expectations of patients across both regimes. Further coherence would require aligning not only the standard, but also the role played by consent under each regime. Here we argue that, in relation to direct care, any such shift should be away from consent as the normal justification. In relation to health research, on the contrary, it should be toward consent as the normal justification for use and disclosure of patient information under both the CLDoC and data protection law.

Responsible use of negative research outcomes-accelerating the discovery and development of new antibiotics.

Failure to share and make use of existing knowledge, particularly negative research outcomes, has been recognized as one of the key sources of waste and inefficiency in the drug discovery and development process. In the field of antibiotic research, providing a platform where negative outcomes could be shared to prevent the vicious cycle of duplicating costly studies that produce the same negative results would greatly de-risk and accelerate the development of new antibiotics. Providing a legally supported framework that recognizes negative outcomes as intellectual contributions, which can subsequently be translated into a revenue-sharing model, may lead to more openness and value creation in support of a sustainable and responsible transformation of research into socially and economically beneficial innovations.

Correia, Diamond and the Chester Exception: Vindicating Patient Autonomy?

In Chester v Afshar [2004], the House of Lords stated they were departing from the traditional rules of causation in order to vindicate the patient's right of autonomy. Subsequent judgments in the Court of Appeal expressed concerns over the lack of clarity of the legal principles to be derived from that judgment. In Correia v University Hospital of North Staffordshire NHS Trust [2017] and Diamond v Royal Devon and Exeter NHS Foundation Trust [2019], however, the Court of Appeal sought to clarify the scope and limits of Chester. This commentary sets out the scope and limits of Chester in light of those judgments and considers the extent to which they can be said to be vindicating patient autonomy. Drawing upon Coggon's typology of autonomy, it concludes that future judgments should utilise that typology to explicate which understanding of autonomy they are seeking to protect.