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Objective: To explore the financial interactions between urology residents and the healthcare industry over a 5-year training period, assessing the implications of these interactions on medical education and practice considering the Physician Payments Sunshine Act., Design: Longitudinal analysis of Open Payments data for a single class of urology residents from 2018 to 2023., Setting: Data were extracted from the CMS Open Payments Database and cross-referenced with residency program information from the American Urological Association (AUA) and the Accreditation Council for Graduate Medical Education (ACGME)., Participants: A cohort of 314 urology residents were identified to have matched in 2018, with 173 residents having reported financial interactions through the Open Payments Program (OPP), representing 55% of the cohort., Results: Analysis revealed that $129,632 was disbursed to the 173 residents throughout their surgical training, with a significant majority (approximately three-quarters or around $100,000) allocated for food and beverage. A statistically significant difference in payment amounts was observed between genders, with male residents receiving an average of $869 compared to $454 for female residents. Payments increased progressively with each postgraduate year (PGY) level, peaking in the fifth year. Despite notable disparities in compensation across AUA sections, no statistically significant variation was found (p = 0.21). The study also highlighted the underestimation of industry influence due to discretionary and heterogeneous reporting practices., Conclusions: The study underscores a significant, yet potentially underreported, financial interaction between urology residents and the healthcare industry, suggesting a deepening relationship as residents progress through their training. The findings call for a more uniform reporting system to enhance transparency and provide a clearer understanding of the industry's role in medical education and practice. Additionally, many residents may not be aware that their financial interactions are being documented and made public, a factor that could influence their professional behavior and expectations., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

This article discusses principles and concepts for ideal regulatory frameworks for diagnostics, and the expression of those principles in the EU IVDR. The authors present the benefits of regulatory frameworks and implementation approaches for diagnostics that are risk-based, globally convergent, connected, nimble and efficient, under the IVDR and with a future outlook. While many expressions of these principles can already be found in the EU IVDR text, and in its implementation approaches, their further embrace is needed in future EU diagnostic regulation. In the long term outlook, risk-based approaches can be extended to comprise entity-based excellence appraisals. Globally convergent approaches can be more explicit in e.g. qualification and classification of products. This will also help further reliance models. Better connections and cooperation between regulators across the healthcare spectrum including pharmaceuticals should be fostered. Nimble approaches such as Emergency Use Authorisations for pandemics are essential in highly regulated schemes like the IVDR and beyond. Finally, regulatory efficiency as in timely availability of IT infrastructure and oversight mechanisms is a distinguishing attribute of globally competitive diagnostic regulatory schemes. All the above needs consideration in the long term efforts to modernize the EU regulatory system, so that diagnostics can play their important role in clinical research as well as along the entire care continuum in the EU., (© 2022 Walter de Gruyter GmbH, Berlin/Boston.)

Competing Interests: Competing interests:RI attended COP26 through her role with Lancet Migration and as an observer for Medact. JK attended as an observer for the Royal College of Psychiatrists

Somatic gene editing (SGE) holds great promise for making genetic therapy possible for many monogenic conditions very soon. Is our current system of European market authorization and reimbursement ready for the expected tsunami of gene therapies? At a recent workshop of the Netherlands ZonMw consortium on ethical, legal, and social implications of personalized medicine, we discussed the current possibilities for bringing new gene therapies to the clinic. In Europe, it is not yet clear whether the route via the European medicines agency as an advanced therapy medicinal product is the most appropriate for evaluation of highly personalized SGE applications, although this may optimally guarantee safety and effectiveness. Compassionate use may ensure faster access than the centralized procedure but does not stimulate the commercial development of products. Prescription to named patients may only provide adequate access for single patients. Temporary authorization of use may allow access to medication half a year before formal market authorization has been granted, but may also have large budget impacts. Magistral compounding under a hospital exemption may be an attractive solution for rare, tailor-made applications at an acceptable price. To approve local experimental use of a therapy on a case-by-case basis may be fast, but does not guarantee optimal safety, effectiveness, and broad implementation. We argue that alternative routes should be considered for products developed for a market of large groups of patients versus unique personalized treatments. A balance between scientific evidence for safety and effectiveness, affordability, and fast access may demand a range of alternative solutions., (© 2021. The Author(s).)

This paper maps key regulatory, governance and legal challenges associated with the UK's withdrawal from the European Union (EU) in terms of convergent and divergent pressures within the global pharmaceutical sector. These include (i) convergent regulatory pressures associated with the European framework for pre-market licensing; (ii) convergent and divergent industry pressures with regard to drug discovery and manufacturing; and (iii) divergent and convergent market pressures associated with the supply, pricing and assessment of medicines. The UK's sovereign ambitions risk a loss of influence over the licensing and surveillance of pharmaceuticals under convergent regulatory and industry pressures to engage in unilateral participation in the European regime. Further, they also risk a loss of influence over processes for pricing and assessing the effectiveness of new treatment regimens under divergent market pressures from larger pharmaceutical markets outside the EU, notably the United States.

Systemic discrimination in healthcare plagues marginalized groups. Physicians incorrectly view people of color as having high pain tolerance, leading to undertreatment. Women with disabilities are often undiagnosed because their symptoms are dismissed. Low-income patients have less access to appropriate treatment. These patterns, and others, reflect long-standing disparities that have become engrained in U.S. health systems. As the healthcare industry adopts artificial intelligence and algorithminformed (AI) tools, it is vital that regulators address healthcare discrimination. AI tools are increasingly used to make both clinical and administrative decisions by hospitals, physicians, and insurers--yet there is no framework that specifically places nondiscrimination obligations on AI users. The Food and Drug Administration has limited authority to regulate AI and has not sought to incorporate anti-discrimination principles in its guidance. Section 1557 of the Affordable Care Act has not been used to enforce nondiscrimination in healthcare AI and is under-utilized by the Office of Civil Rights. State level protections by medical licensing boards or malpractice liability are similarly untested and have not yet extended nondiscrimination obligations to AI. This Article discusses the role of each legal obligation on healthcare AI and the ways in which each system can improve to address discrimination. It highlights the ways in which industries can self-regulate to set nondiscrimination standards and concludes by recommending standards and creating a super-regulator to address disparate impact by AI. As the world moves towards automation, it is imperative that ongoing concerns about systemic discrimination are removed to prevent further marginalization in healthcare., (Copyright by Cleveland State University.)

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Cochlear and brainstem implants have been included on the list of reimbursable products (LPPR) in France since March of 2009. The implants were initially inscribed for 5 years, after which an application for renewal with the French National Commission for the Evaluation of Medical Devices and Health Technologies (Commission Nationale d'évaluation des dispositifs médicaux et des technologies de santé - CNEDiMTS) was required [Haute Autorité de santé, 2009]. Upon registration to the list of reimbursable products, the companies and the reference centers for cochlear and brainstem implants were asked to set up a post-registration registry called EPIIC. This article reports the evolution in the EPIIC registry of the general indicators for 5051 patients over the five years from 2012-2016., (Copyright © 2020. Published by Elsevier Masson SAS.)

This contribution delves into the EU Regulation 2016/679 that defines the accountability of data controllers, with regard to the processing of personal data, and imposes the adoption of technological and organizational measures demonstrating a full commitment to European data protection laws. A risk-based analysis and an impact-based approach are recommended for all personal data, and especially those concerning health, in order to safeguard the rights and freedoms of the data subjects. The article also describes the processes that should be put in place to avoid errors and violations in the handling of personal data, which can result in physical, material or non-material damage to natural persons. The controller, in fact, needs to evaluate the situation carefully and follow a series of compulsory steps to assess any potential weaknesses in the system. A balancing act between public health concerns and privacy protection is necessary; this can be obtained through a detailed analysis of the norms and their careful implementation., (Copyright by Società Italiana di Nefrologia SIN, Rome, Italy.)

Background and Purpose- Industry payments to physicians raise concerns regarding conflicts of interest that could impact patient care. We explored nonresearch and nonownership payments from industry to vascular neurologists to identify trends in compensation. Methods- Using Centers for Medicare and Medicaid Services and American Board of Psychiatry and Neurology data, we explored financial relationships between industry and US vascular neurologists from 2013 to 2018. We analyzed payment characteristics, including payment categories, payment distribution among physicians, regional trends, and biomedical manufacturers. Furthermore, we analyzed the top 1% (by compensation) of vascular neurologists with detailed payment categories, their position, and their contribution to stroke guidelines. Results- The number of board certified vascular neurologist increased from 1169 in 2013 to 1746 in 2018. The total payments to vascular neurologist increased from $99 749 in 2013 to $1 032 302 in 2018. During the study period, 16% to 17% of vascular neurologists received industry payments. Total payments from industry and mean physician payments increased yearly over this period, with consulting fee (31.1%) and compensation for services other than consulting (30.7%) being the highest paid categories. The top 10 manufacturers made the majority of the payments, and the top 10 products changed from drug or biological products to devices. Physicians from south region of the United States received the highest total payment (38.72%), which steadily increased. Payments to top 1% vascular neurologists increased from 64% to 79% over the period as payments became less evenly distributed. Among the top 1%, 42% specialized in neuro intervention, 11% contributed to American Heart Association/American Stroke Association guidelines, and around 75% were key leaders in the field. Conclusions- A small proportion of US vascular neurologists consistently received the majority of industry payments, the value of which grew over the study period. Only 11% of the top 1% receiving industry payments have authored American Heart Association/American Stroke Association guidelines, but ≈75% seem to be key leaders in the field. Whether this influences clinical practice and behavior requires further investigation.

The direct-to-consumer genetic testing (DTC-GT) market has been developing for about twenty years now, raising various debates, even controversies. But what about the regulation of these so-called "innovative" devices, but whose medical status is ambiguous? A first regulatory aspect is depending on the market itself, since the latter is currently subjected to a strong structuring process. A second regulatory aspect, more classical, is the legal one. While the DTC-GT status has long been unclear on European scale, a new text (a Regulation, not a Directive) is modifying the situation. It encourages regulation "by the market" rather than "by the medical profession", which does not imply that the latter will have no (indirect) impact on the DTC-GT market., (© 2020 médecine/sciences – Inserm.)

Background: Section 6002 of the Affordable Care Act, commonly referred to as "The Sunshine Act," is legislation designed to provide transparency to the relationship between physicians and industry. Since 2013, medical product and pharmaceutical manufacturers were required to report any payments made to physicians to the Centers for Medicare and Medicaid Services (CMS). We predicted that most clinical faculty at our institution would be found on the Open Payments website. We elected to investigate payments in relationship to divisions within the department of surgery and the level of professorship., Methods: All clinical faculty (n = 86) within the department of surgery at our institution were searched within the database: https://openpaymentsdata.cms.gov/. The total amount of payments, number of payments, and the nature of payments (food and beverage, travel and lodging, consulting, education, speaking, entertainment, gifts and honoraria) were recorded for 2017. Comparison by unpaired t-test (or ANOVA) where applicable, significance defined as P < 0.05., Results: Of the 86 faculty studied, 75% were found within the CMS Open Payments database in 2017. The mean amount of payment was $4024 (range $13-152,215). Median amount of payment was $434.90 (range $12.75-152,214.70). Faculty receiving outside compensation varied significantly by division and academic rank (P < 0.05). Plastic surgery had the highest percentage of people receiving any form of payment ($143-$1912) and GI surgery had the largest payments associated with device management ($0-$152,215). The variation seen by rank was driven by a small number of faculty with receipt of large payments at the associate professor level. The median amount of payment was $428.53 (range $13.97-2306.05) for assistant professors, $5328.03 (range $28.30-152,214.70) for Associate Professors, and $753.82 (range $12.75-17,708.65) for full professors., Conclusions: Reporting of open payments to CMS provides transparency between physicians and industry. The significant relationship of division and rank with open payments database is driven by relatively few faculty. The majority (94%) received either no payments or less than $10,000., (Copyright © 2019 Elsevier Inc. All rights reserved.)

The article examines the issue of public procurement in the healthcare sector through the prism of the Association Agreement with the EU. The emphasis is on the ensuring mutual access to the markets of public procurement of the EU and Ukraine on the basis of planned and consistent approximation of Ukrainian legislation in the field of public procurement to the EU acquis in the field of public procurement. The purpose of this article is to identify the peculiarities of the reform in the field of public procurement in Ukraine, to search for drawbacks in the administrative legislation of Ukraine, which is governing public procurement in the healthcare sector in the context of Ukraine's implementation of the Association Agreement with the EU, and to justify its improvement. The subject of research is the social relations that arise in the implementation of public procurement in the field of health. The methodological basis of the conducted research is the general methods of scientific cognitivism as well as concerning those used in legal science: methods of analysis and synthesis, formal logic, comparative law, statistical methods etc The following main directions of reforming the system of public procurement were established. It has been proved that CPO functioning on the national level of government in the form of a state-owned enterprise under the control of one of the relevant ministries is non-feasibility. The advantages of the ProZorro electronic procurement system and the state of implementation of the provisions of the EU Directives on 2014/23/ EU, 2014/24/ EU, 2014/25/EU, 2014/55/EU into the administrative legislation of Ukraine have been identified. It has been found that in March, 2015 centralized procurement system for medicines and medical products was changed in Ukraine to use the funds of the State Budget of Ukraine for the purchase of medicines and medical products with the involvement of international specialized organizations. On December 21, 2018 the Verkhovna Rada (Supreme Council) of Ukraine put amendments into the Law of Ukraine "On Public Procurement". The attention is paid to the novelties of this Law. It has been found that the legislation of Ukraine has such shortcomings: 1) in Ukraine the issue of clear distribution of functions of the authorities authorized to carry out control in the field of public procurements remains unresolved; 2) the norms of the Law contradict each other; 3) the problems of creating effective mechanisms for the formation of the nomenclature of medicines still remain, as well as their supplies to healthcare institutions.

More than 25 years ago, Professors David Wexler and Bruce Winick envisioned broad application of therapeutic jurisprudence (TJ), an interdisciplinary theory of law suggesting that legislatures, regulators, and judges consider the extent to which their decisions impact the psychological well-being of those upon whom the law acts. TJ most obviously plays a significant role in mental health and criminal law, where it originated, but Wexler and Winick long ago opined that TJ could be useful in a wide variety of other disciplines as well. Indeed, TJ has expanded exponentially in application over the years. Yet, although Wexler and Winick originally suggested that health law was an "obvious" field in which it could expand, application of TJ in that discipline has been less robust than one might have expected. This article will examine the extent to which TJ has been applied in health law other than mental health law, categorize the areas of health law in which it has been applied, and suggest future paths for expansive application in this most obvious of areas., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

In a context of perpetual evolution of treatments, access to therapeutic innovation is a major challenge for patients and the various players involved in the procedures of access to medicines. The revolutions in genomic and personalized medicine, artificial intelligence and biotechnology will transform the medicine of tomorrow and the organization of our health system. It is therefore fundamental that France prepares for these changes and supports the development of its companies in these new areas. The recent "Conseil stratégique des industries de santé" launched by Matignon makes it possible to propose a regulatory arsenal conducive to the implementation and diffusion of therapeutic innovations. In this workshop, we present a number of proposals, our approach having remained pragmatic with a permanent concern to be effective in the short term for the patients and to simplify the procedures as much as possible. This was achieved thanks to the participation in this workshop of most of the players involved (industrial companies, "Agence nationale de sécurité du médicament et des produits de santé", "Haute Autorité de santé", "Institut national du cancer", "Les entreprises du médicament", hospitals, "Observatoire du médicament, des dispositifs médicaux et de l'innovation thérapeutique"…). The main proposals tend to favor the implementation of clinical trials on our territory, especially the early phases, a wider access to innovations by favoring early access programs and setting up a process called "autorisation temporaire d'utilisation d'extension" (ATUext) that make it possible to prescribe a medicinal product even if the latter has a marketing authorisation in another indication. In addition, we propose a conditional reimbursement that will be available based on preliminary data but will require re-evaluation based on consolidated data from clinical trials and/or real-life data. Finally, in order to better carry out these assessments, with a view to access or care, we propose the establishment of partnership agreements with health agencies/hospitals in order to encourage the emergence of field experts, in order to prioritize an ascending expertise closer to patients' needs and to real life., (Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)

Competing Interests: Competing interests: None declared.

In 2018, the Medicare Part D catastrophic threshold is $5000 in out-of-pocket total drug spending incurred by the beneficiary. Above this, Medicare pays 80%, prescription drug plans (PDPs) pay 15%, and beneficiaries pay a 5% copay. However, recent growth in catastrophic spending is caused by expensive specialty drugs. The 5% copay, on top of out-of-pocket spending, could result in beneficiaries not accessing specialty drugs. To assist beneficiaries, the Medicare Payment Advisory Commission (MedPAC) proposes to eliminate beneficiary catastrophic cost sharing, while PDPs pay 80% and Medicare pays 20%. Our objective was to assess other government cost-sharing approaches and consider how they would affect pharmaceutical access, PDP Part D incentives, and pharmaceutical innovation. We reviewed published literature and government reports on cost sharing between US government divisions or between government and private commercial entities. We discussed their cost-sharing applicability to Part D. We found that the US government has utilized numerous cost-sharing approaches to enhance public-private partnerships. We reviewed four cost-sharing arrangements and their applicability to Medicare: the Byrd-Bond Amendment to the Clean Air Act-Medicare bulk purchases drugs costing $8000 + ; North Atlantic Treaty Organization (NATO)-cost sharing based on high-risk markets; the Ryan White Ryan White Comprehensive AIDS Resources Emergency (CARE) Act-grants to PDPs in high-risk markets and grants to beneficiaries who cannot afford drugs; and the Department of Veterans Affairs-drug price negotiation for expensive drugs. In conclusion, a variety of federal cost-sharing approaches provide precedent for altering PDP cost sharing. The government tends to prefer options that have been tried elsewhere.

October brought new guidance on state waivers, more litigation, and preparation for the next open enrollment period.

Objective: To evaluate financial relationships between obstetrician-gynecologists (ob-gyns) and industry, including the prevalence, magnitude, and the nature of payments., Methods: We conducted a cross-sectional study in which we obtained a list of industry contributions to U.S. obstetricians and gynecologists through the Centers for Medicare and Medicaid Services Open Payments Database from August 1, 2013, to December 31, 2015. These data were cross-referenced with the entire cohort of practicing obstetricians and gynecologists, who were identified using the National Provider Identification database, because not all practicing ob-gyns received payments. These payments were analyzed with respect to 1) types of payments, 2) demographic attributes of health care providers receiving payments, and 3) comparisons between obstetrician and gynecologist subspecialties. Continuous data were compared using the Mann-Whitney test for variables that were not normally distributed and with the t test for variables that are normally distributed., Results: A total of 517,077 nonresearch payments, totaling $79,965,244, were made to 23,292 ob-gyns. Physicians receiving payments were predominantly female, younger than 65 years old, allopathic physicians who graduated from U.S. medical schools in the late 1990s, and were board-certified subspecialists (P<.001 for all). Half of all ob-gyns received payments of varying amounts from drug manufacturers, device manufacturers, or both, with most of the payments for honoraria, faculty compensation, or consulting. Female pelvic medicine and reconstructive surgery physicians received the largest median dollar amount; maternal-fetal medicine physicians received the smallest., Conclusion: Obstetricians and gynecologists receive a substantial amount of payments from industry. Most of these payments were for honoraria, faculty compensation, or consulting and totaled less than $400 per health care provider. Although this total amount is less than typically received by surgical providers, including orthopedic surgeons who account for the highest compensated group in total and mean industry payments, the median payment value for obstetrics and gynecology subspecialists surpasses the median payment to orthopedic surgeons. These financial relationships warrant further exploration with future research.

Background: Differences in payer evaluation and coverage of pharmaceuticals and medical procedures suggest that coverage may differ for medications and procedures independent of their clinical benefit. We hypothesized that coverage for medications is more restricted than corresponding coverage for nonmedication interventions., Methods: We included top-selling medications and highly utilized procedures. For each intervention-indication pair, we classified value in terms of cost-effectiveness (incremental cost per quality-adjusted life-year), as reported by the Tufts Medical Center Cost-Effectiveness Analysis Registry. For each intervention-indication pair and for each of 10 large payers, we classified coverage, when available, as either "more restrictive" or as "not more restrictive," compared with a benchmark. The benchmark reflected the US Food and Drug Administration label information, when available, or pertinent clinical guidelines. We compared coverage policies and the benchmark in terms of step edits and clinical restrictions. Finally, we regressed coverage restrictiveness against intervention type (medication or nonmedication), controlling for value (cost-effectiveness more or less favorable than a designated threshold)., Results: We identified 392 medication and 185 procedure coverage decisions. A total of 26.3% of the medication coverage and 38.4% of the procedure coverage decisions were more restrictive than their corresponding benchmarks. After controlling for value, the odds of being more restrictive were 42% lower for medications than for procedures. Including unfavorable tier placement in the definition of "more restrictive" greatly increased the proportion of medication coverage decisions classified as "more restrictive" and reversed our findings., Conclusions: Therapy access depends on factors other than cost and clinical benefit, suggesting potential health care system inefficiency., (Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

The vast consolidation among health-care providers in the aftermath of the Affordable Care Act's enactment has led to much debate over the benefits of mergers in the health-care industry. In 2016, the Federal Trade Commission filed motions in federal court to enjoin three hospital mergers in various parts of the country. This amounted to more challenges to hospital mergers in a single year than any year in recent history. Though two of these motions succeeded at the district court level, both were overturned on appeal, which led many to wonder what the effect of these decisions would be on future health-care mergers. While many fear that hospital mergers lead to higher prices for consumers, there are also those who contend that mergers lead to efficiencies, which allow merging parties to utilize resources more effectively, increase the quality of patient care and coordination, and potentially save lives. This Note argues that the possibility of quality-enhancing or life-saving efficiencies is worth the risk that consumers see increased prices. To allow mergers that may realize these types of efficiencies, antitrust enforcement agencies and courts must begin placing greater weight on merging parties' efficiency arguments by easing the current standard. Additionally, in light of new research suggesting that cross-market health-care mergers, or mergers between providers in different geographic markets, affect bargaining dynamics between providers and insurers, this Note argues that parties' relative bargaining power must be considered in agencies' and courts' analyses of the competitive landscape relevant to a merger.

Legitimately categorizing software in the healthcare sector is complex. According to European medical devices law, software can be considered a medical device. The decisive factor is whether the software is used for directly controlling a therapeutic or diagnostic medical device or as stand-alone software that achieves specific medical purposes, as they are described in the legal definition of a medical device. A contribution of the software to diagnosis or therapy can be sufficient for the categorization; it does not have to provide the complete diagnosis or the complete therapy itself.This principle will continue to be the same with the new Regulation on Medical Devices (EU) 2017/745, even though the classification rules have been more closely and more specifically tailored to software and more stringent requirements for essential safety and performance requirements have to be met.

Digital health products and services have started to fundamentally change healthcare and prevention. Products intended for a medical use require CE-marking and potentially certification (ISO 13485) of the company. Startups play an important role in the development of new digital products and services. Two startups share their experience with these processes. Becoming a part of standard care and hence being reimbursed is a challenge for startups. For this reason, startups pursue alternative sources of income, too. The statutory health insurance's procedures for assessing new products and services are perceived as long. Startups are required to provide evidence of the benefit of their product at an early stage in the procedure. This requires time-consuming and costly studies. Startups would therefore appreciate support in generating this evidence, e. g. through adequate procedures for testing.

Policy Points: Policymakers seek to transform the US health care system along two dimensions simultaneously: alternative payment models and new models of provider organization. This transformation is supposed to transfer risk to providers and make them more accountable for health care costs and quality. The transformation in payment and provider organization is neither happening quickly nor shifting risk to providers. The impact on health care cost and quality is also weak or nonexistent. In the longer run, decision makers should be prepared to accept the limits on transformation and carefully consider whether to advocate solutions not yet supported by evidence., Context: There is a widespread belief that the US health care system needs to move "from volume to value." This transformation to value (eg, quality divided by cost) is conceptualized as a two-fold movement: (1) from fee-for-service to alternative payment models; and (2) from solo practice and freestanding hospitals to medical homes, accountable care organizations, large hospital systems, and organized clinics like Kaiser Permanente., Methods: We evaluate whether this transformation is happening quickly, shifting risk to providers, lowering costs, and improving quality. We draw on recent evidence on provider payment and organization and their effects on cost and quality., Findings: Data suggest a low prevalence of provider risk payment models and slow movement toward new payment and organizational models. Evidence suggests the impact of both on cost and quality is weak., Conclusions: We need to be patient in expecting system improvements from ongoing changes in provider payment and organization. We also may need to look for improvements in other areas of the economy or to accept and accommodate prospects of modest improvements over time., (© 2018 Milbank Memorial Fund.)

Background: Regulating the behavior of private providers in the context of mixed health systems has become increasingly important and challenging in many developing countries moving towards universal health coverage including Mongolia. This study examines the current regulatory architecture for private healthcare in Mongolia exploring its role for improving accessibility, affordability, and quality of private care and identifies gaps in policy design and implementation., Methods: Qualitative research methods were used including documentary review, analysis, and in-depth interviews with 45 representatives of key actors involved in and affected by regulations in Mongolia's mixed health system, along with long-term participant observation., Results: There has been extensive legal documentation developed regulating private healthcare, with specific organizations assigned to conduct health regulations and inspections. However, the regulatory architecture for healthcare in Mongolia is not optimally designed to improve affordability and quality of private care. This is not limited only to private care: important regulatory functions targeted to quality of care do not exist at the national level. The imprecise content and details of regulations in laws inviting increased political interference, governance issues, unclear roles, and responsibilities of different government regulatory bodies have contributed to failures in implementation of existing regulations., (Copyright © 2017 John Wiley & Sons, Ltd.)

We explore the influence of the Thirteenth Amendment to the US Constitution on the enforceability of personal services contracts for physicians. This influence extends from the ambiguous definition to the legal interpretation of personal services contracts. The courts have struggled with determining contracts to be a personal service and whether to grant injunctions for continued performance. The award or denial of damages due to a breach of contract is vested in these enforceability complications. Because of the Thirteenth Amendment's influence, courts and contracting parties will continue to struggle with physician personal services contract enforceability; although other points of view may exist. Possible solutions are offered for health care contract managers dealing with challenges attributable to physician personal services contracts.

In 2016, the Office of the State Coroner of New South Wales released its report into the death of an Australian woman, Sheila Drysdale, who had died from complications of an autologous stem cell procedure at a Sydney clinic. In this report, we argue that Mrs Drysdale's death was avoidable, and it was the result of a pernicious global problem of an industry exploiting regulatory systems to sell unproven and unjustified interventions with stem cells., Competing Interests: Competing interests: IK is a bone marrow transplant physician, chair of New South Wales Bone Marrow Transplant Network Long Term Follow-Up Working Group, board member of New South Wales Stem Cell Network and member of the National Health and Medical Research Council's Xenotransplantation Committee. No further competing interests to declare., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Purpose: This paper describes the development of quality indicators for an external statutory and cross-sectoral quality assurance (QA) procedure in the context of the German health care system for adult patients suffering from schizophrenia, schizotypal and delusional disorders (F20-F29)., Methods: Indicators were developed by a modified RAND/UCLA Appropriateness Method with 1) the compilation of an indicator register based on a systematic literature search and analyses of health care claims data, 2) the selection of indicators by an expert panel that rated them for relevance and for feasibility regarding implementation. Indicators rated positive for both relevance and feasibility formed the final indicator set., Results: 847 indicators were identified by different searches. Out of these, 56 were selected for the indicator register. During the formal consensus process the expert panel recommended another 45 indicators so that a total of 101 indicators needed to be considered by the panel. Of these, 27 indicators rated both relevant and feasible were included in the final set of indicators: this set included 4 indicators addressing structures, 19 indicators addressing processes and 4 indicators addressing outcomes. 17 indicators of the set will be reported by hospitals and 8 by psychiatric outpatient facilities. Two indicators considered to be cross-sectoral will be reported by both sectors., Discussion: F20-F29 and its treatment show some specific features which so far have not been addressed by any procedure within the statutory QA program of the German health care system. These features include: Schizophrenia and related disorders a) are potentially chronic conditions, b) are mainly treated in outpatient settings, c) require a multi-professional treatment approach and d) are treated regionally in catchment areas. These specific features in combination with the peculiarities of some legal, political and organizational characteristics of the German health care system and its statutory QA program have strongly influenced the development of indicators. The result was a seemingly "imbalanced" set of indicators with a greater number of indicators for inpatient than for outpatient care despite the fact that clinical reality is otherwise., Conclusions: The circumstances of the German health care system that restricted the development of this cross-sectoral QA procedure addressing care for F20-F29 are also most likely to emerge with the development of cross-sectoral QA procedures for other (potentially) chronic conditions that are mainly treated in the outpatient setting by multi-professional teams or by networks of different providers. In order to be able to develop a QA procedure that mirrors the reality of service provision for (potentially) chronic diseases such as F20-F29 we need to explore further current and new data sources, diminish sectoral borders, and implement health care responsibility on the level of catchment areas., (Copyright © 2017. Published by Elsevier GmbH.)

Decentralized or "redistributed" manufacturing has the potential to revolutionize the manufacturing approach for cell and gene therapies (CGTs), moving away from the "Fordist" paradigm, delivering health care locally, customized to the end user and, by its very nature, overcoming many of the challenges associated with manufacturing and distribution of high volume goods. In departing from the traditional centralized model of manufacturing, decentralized manufacturing divides production across sites or geographic regions. This paradigm shift imposes significant structural and organisational changes on a business presenting both hidden challenges that must be addressed and opportunities to be embraced. By profoundly adapting business practices, significant advantages can be realized through a democratized value chain, creation of professional-level jobs without geographic restriction to the central hub and a flexibility in response to external pressures and demands. To realize these potential opportunities, however, advances in manufacturing technology and support systems are required, as well as significant changes in the way CGTs are regulated to facilitate multi-site manufacturing. Decentralized manufacturing is likely to be the manufacturing platform of choice for advanced health care therapies-in particular, those with a high degree of personalization. The future success of these promising products will be enhanced by adopting sound business strategies early in development. To realize the benefits that decentralized manufacturing of CGTs has to offer, it is important to examine both the risks and the substantial opportunities present. In this research, we examine both the challenges and the opportunities this shift in business strategy represents in an effort to maximize the success of adoption., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

The United States relies on competition to balance costs and quality in the health care system. But concentration is increasing throughout the hospital, physician, and insurer markets. Midsize community hospitals face declining demand and growing competition from both larger hospitals and smaller freestanding diagnostic and surgical centers, leaving the midsize hospitals vulnerable to closure or merger with other facilities. Competition among insurers has been limited by the development of hospital systems that extend the bargaining power of "must-have" hospitals (those perceived to provide the best care for complex and less common conditions) across local health care markets. Government antitrust enforcement could play an important role in maintaining competition in both the hospital and insurer markets, but in many markets, the impact of that enforcement has been limited to date. Policy makers should consider supplementing antitrust activities with strategies that combine competition and regulation-for example, by regulating selected prices and structuring competition to cover entire insurance markets., (Project HOPE—The People-to-People Health Foundation, Inc.)

This article considers the issue of expanded access to innovative treatments in the context of recent legislative initiatives in the United Kingdom and the United States. In the United Kingdom, the supporters of legislative change argued that the common law principles governing medical negligence are a barrier to innovation. In an attempt to remove this perceived impediment, two bills proposed that innovating doctors sued for negligence should be able to rely in their defence on the fact that their decision to innovate was "responsible." A decision to innovate would be regarded as responsible if it followed a specified process. Although these changes to the law of medical negligence were not passed, this article argues that the idea of a process-based approach was sound. In the United States, a number of states have passed "Right to Try" laws that permit doctors to prescribe and companies to provide investigational products without the need for FDA approval. These laws do not purport to and nor are they able to alter the obligations of individuals and companies under federal law. They are consequently unlikely to achieve their stated aim of expanding access to investigational products. This article argues that they nevertheless have a cogent rationale in so far as they highlight the need for rights-based reform to federal regulations governing access.

Physician-inventors are in a unique position to identify unserved patient needs, and innovate solutions to clinical problems. These solutions may also have associated commercial opportunities. The logistics of developing these medical products, however, can seem a daunting task. One of the primary barriers in the United States is the regulatory process of the Food and Drug Administration (FDA). In this article, we will explore the risk-based approach used by the FDA which forms a framework to consider the regulatory pathway and the process to gain regulatory clearance or approval for medical devices. Inherent device properties and the procedural risk of the devices will determine the rigor with which they are scrutinized by FDA, and the evidentiary requirements to legally market them. Data and evidentiary development will vary depending on risk and regulatory precedent and may or may not require clinical data This regulatory paradigm will determine into which risk-based device class they fit, and whether they are regulated under the 510(k) or premarket approval application pathways. The FDA, although gatekeeper of the US market and tasked with determining which products are safe and effective, can be a powerful ally for product development. They have significant scientific and medical expertise, and mechanisms to both provide guidance, and also to consider novel approaches to product development and evidence development. Early interaction for routine and novel products alike can result in expedited and efficient development. This collaborative approach can be best practice to most expeditiously develop the next generation of products, getting them into the hands of US doctors and into the treatment of US patients., (Copyright © 2017. Published by Elsevier Inc.)

Intellectual property (IP) is a term that describes a number of distinct types of intangible assets. IP protection allows a rightsholder to exclude others from interfering with or using the property right in specified ways. The main forms of IP are patents, copyrights, trademarks, and trade secrets. Each type of IP protection is different, varying in the subject matter that can be covered, timeframe of protection, and total expense. Although some inventions may be covered by multiple types of IP protection, it is important to consider a number of business and legal factors before selecting the best protection strategy. Some technologies require strong IP protection to commercialize, but unnecessary costs can derail bringing a product to market. IP departments of organizations weigh these various considerations and perform essential IP protection functions. This primer introduces researchers to the main forms of IP and its legal aspects., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: The Physician Payments Sunshine Act (PSSA) is a government initiative that requires all biomedical companies to publicly disclose payments to physicians through the Open Payments Program (OPP). The goal of this study was to use the OPP database and evaluate all nonresearch-related financial transactions between plastic surgeons and biomedical companies., Methods: Using the first wave of OPP data published on September 30, 2014, we studied the national distribution of industry payments made to plastic surgeons during a 5-month period. We explored whether a plastic surgeon's scientific productivity (as determined by their h-index), practice setting (private versus academic), geographic location, and subspecialty were associated with payment amount., Results: Plastic surgeons (N = 4195) received a total of US $5,278,613. The median (IQR) payment to a plastic surgeon was US $115 (US $35-298); mean, US $158. The largest payment to an individual was US $341,384. The largest payment category was non-CEP speaker fees (US $1,709,930) followed by consulting fees (US $1,403,770). Plastic surgeons in private practice received higher payments per surgeon compared with surgeons in academic practice (median [IQR], US $165 [US $81-$441] vs median [IQR], US $112 [US $33-$291], rank-sum P < 0.001). Among academic plastic surgeons, a higher h-index was associated with 77% greater chance of receiving at least US $1000 in total payments (RR/10 unit h-index increase = 1.47 1.772.11, P < 0.001). This association was not seen among plastic surgeons in private practice (RR = 0.89 1.091.32, P < 0.4)., Conclusions: Plastic surgeons in private practice receive higher payments from industry. Among academic plastic surgeons, higher payments were associated with higher h-indices.