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Only a few physicians are willing to comprehensively concern themselves with how a legally watertight treatment documentation should be structured, in addition to their practical activities; however, the importance of the documentation cannot be emphasized enough, not only for a potential case of liability but also for the medical (further) treatment. This article therefore illustrates the legal foundations of the mandatory documentation and the most important questions associated with it for the practice, in particular on the content of the documentation, the timing of the documentation, the preservation of treatment documents and on the conduct in cases of an impending incident., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Abusive head trauma (AHT) is a criminal offence that is prosecuted ex officio, following report to the police from physicians or child protection services. The aim of this study was to assess whether the judicial outcome (dismissal vs indictment) was influenced by the quality of the medical documentation and/or the time span between AHT diagnosis and reporting child abuse to the police. The cohort was divided in two groups: 13/23 dismissals (57%) and 10/23 indictments (43%). The diagnostic probability of the AHT cases was certain for both groups. Nonetheless, in fraction of dismissed cases, alternative explanations for the observed lesions seemed plausible to the public prosecutor. Legal files of only 3/12 dismissed cases had a forensic report, while 6/10 cases that were indicted included a forensic report. Further, the legal file of several dismissed cases entirely lacked medical documentation (3/12), which was not the cases for indicted cases. The period between AHT diagnosis and reporting to the police was not different for dismissals (29 ± 19 days) and indictments (7 ± 4 days) (p = 0.32). Physicians filed reports more rapidly (6 ± 1 days) compared to childhood protection service (70 ± 46 days) (p = 0.01) and that may increase the rate of indictments (9/18) compared to reporting via the childhood protection service (1/5). Despite diagnostic certainty, other causes for the lesions were considered as plausible alternative explanations to judicial professionals in several dismissed cases. These seemed to have less medical documentation and forensic evaluations. In addition, more rapid reporting to the police by physicians seems to increase the likelihood of indictments., (© 2024. The Author(s).)

EU data protection law and medical research ethics overlap in scope and content in numerous instances in which personal data are processed in medical research. It is not always the case, however, that the conditions outlined by the two rule-sets precisely coincide. In the past few years, this lack of confluence has led to confusion as to how the two rule-sets should best relate to one another. This confusion has led to different approaches to the relationship being taken, on occasion leading to counter-intuitive conclusions. Unfortunately, there has hitherto been little effort to provide clarity to this confusion. In this regard, this article attempts to provide a general normative framework aimed at facilitating optimally cogent and just reconciliations of EU data protection law and medical research ethics., (© The Author(s) 2021. Published by Oxford University Press; All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objectives: To evaluate critical care nurses' experiences of ICU diaries following the implementation of national recommendations for the use of diaries for critically ill patients., Design: A quality improvement project describing the development and implementation of national recommendations (2011), as well as the assessment of the use of diaries in intensive care nursing practice (2014)., Setting: Norwegian intensive care units (ICUs)., Participants: Thirty-nine Norwegian ICUs took part in the study., Intervention: A multi-component process for developing national recommendations for the use of diaries in Norwegian ICUs, including recommendations for the target group, when to start, health professionals as authors, diary content, structure, language, use of photographs, handover, access and storage within patient medical records., Main Outcome Measure: A questionnaire asking about experiences of implementing national recommendations on diaries in Norwegian ICUs, as well as their impact and how they are used., Results: Three years after the implementation of the national recommendations, diaries were provided in 24 (61.5%) of the responding ICUs. Fifty-six per cent of the ICUs had revised their routines, of which 62% had updated and 38% had developed new protocols. Most ICUs kept the diary along with other medical information describing patient care, but only 50% of the ICUs scanned handwritten diaries into the electronic medical records before handing them over to patients or the bereaved. ICU nurses reported that implementing national recommendations had increased their awareness and knowledge on patient and family needs, as well as the long-term effects of critical illness., Conclusion: The results of this quality improvement project indicate that access to national recommendations on the use of diaries for critically ill patients have a potential of changing routines and increase standardisation., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)

In France, clinical research involving human beings is regulated by the Jardé's law since November 2016. The law distinguishes interventional and non-interventional studies. Both need to be authorized by a Persons Protection Committee. Studies performed on medical data collected during standard clinical care are not considered as studies involving human beings. Medical data are personal data. French Data Protection Authority National has an important role, guarantying the respect of regulation on personal data. We summarize in this article the different types of studies and the role of regulatory authorities., (Copyright © 2019 Société Nationale Française de Médecine Interne (SNFMI). Published by Elsevier Masson SAS. All rights reserved.)

Health data, increasingly accessible and transparent, are attractive preys for the creation of value in the digital market. The concept of personal and anonymous data has by now disappeared in a sort of "far web" of filing and obsessive profiling, out of control, in which the violation of privacy seems systematic. The protection of confidentiality requires above all a cultural response, capable of aligning the current contexts, produced by the ever more advanced computational intelligences, with the recovery and promotion of people's rights.

The physician's duty of confidentiality is based on the observance of the patient's privacy and intimacy and on the importance of respecting both of these rights, thus creating a relationship of confidence and collaboration between doctor and patient. The main objective of this work consists of analyzing the aspects that are related to the confidentiality of patients' data with respect to the training, conduct and opinions of doctors from different Clinical Management Units of a third-level hospital via a questionnaire. The present study aimed to define the problem and determine whether the opinions of these professionals correspond to those observed in a previous work conducted at the same center. Of the 200 questionnaires that were collected, 62.5% were from consultants and the rest were from residents (37.5%) with an average of 14.4 ± 12.5 years in professional practice. The respondents noted habitual situations in which confidentiality was breached in the reference hospital (74%). The section on their attitudes and behaviors towards situations related to confidentiality showed a slightly lower average score than that of their medical knowledge; significant differences in these scores were observed between the consultants and residents as well as between the extreme age groups (≤ 30 vs. ≥ 51 years) and years of professional practice, thus more inadequate attitudes were consistently noted in younger doctors who had fewer years of experience. Finally, the respondents answered that the training of doctors in the aspects of healthcare law and ethics was the most important measure that the hospital could adopt regarding confidentiality practices.

"Jane" is a mother of two, who was referred for psychotherapy. However, Jane had misgivings about engaging in the offered psychotherapy because of threats made by her domestically violent partner. The therapy sessions are audio recorded for the purpose of professional supervision and clinician reflective practices. Jane's partner had threatened to subpoena the therapy recordings to legally separate Jane from her children. This article focuses on how three different parts of Jane's multidisciplinary care (i.e. clinicians, policy professionals and medico-legal professionals) exhibit different competing ethical priorities. Psychotherapeutic clinicians private use of audio recordings of the therapy enhances patient care and their own professional development but with the risk of concealing possible unethical behaviour by either party. Medico-legal access to the therapy recordings preserves potentially relevant evidence in the pursuit of justice but risks the interpretation of the psychotherapeutic information outside of the therapeutic context. Policies advocating the inclusion of the therapy recordings in the medical record improves clinician (and health service) accountability but risks harming the vulnerable patient due to threats to patient-therapist confidentiality.

The law of confidence allows for a range of defined circumstances in which confidential patient information (CPI) can be disclosed without breach of confidence-including statutory gateway and overriding public interest. Outside such circumstances, current guidance to health professionals (the 'standard account') assumes that CPI can only be lawfully disclosed with patient consent. This article argues that the standard account has not yet caught up with judgments, post the Human Rights Act 1998 coming into force, which have reinterpreted the law of confidence in the light of Article 8 of the European Convention on Human Rights. In particular, the article explains the significance of the concept of a 'reasonable expectation of privacy' to an action for breach of confidence and thus to legal liability for disclosure of health data. It argues that conformity with a reasonable expectation of privacy provides an alternative account for the lawful disclosure of CPI, and may provide a more sustainable and authentic approach to meeting obligations under the law of confidence than the standard account. The article concludes with recommendations for an evolution of the standard account in a way that could allow restatement of associated concepts (such as consent) free from particular pressure to bend them out of shape. The evolution proposed continues to bring to the fore the patient perspective and allows protection of their 'reasonable expectations' regarding uses of data collected about them rather than those of the profession., (© The Author(s) 2019. Published by Oxford University Press.)

Aims and Objectives: The aim of this study was to properly define the information regarding patient exposure to Ionizing Radiations in the radiological report, according to the European Directive 2013/59/EURATOM (EU 2013/59 art.58(b)). For this purpose, we evaluated the results from other Member States EU 2013/59 transpositions and from Guidelines recommendation published by International Organizations involved in diagnostic radiology. A practical way for implementing art.58 is also traced., Materials and Methods: Dosimetric quantities, such as exposure, absorbed dose and effective dose which may be included in radiological report, were first analyzed; then, in order to define international state of art of Member States EU 2013/59 transposition, a Web research using French, English, Spanish and German key words was performed., Results: EU 2013/59 transposition for 5 Member States was reported. Especially regarding art.58, a European project reports that few European countries (11 of 28) have identified the dose metrics to be used in radiological report. Scientific organizations supporting clinical radiologists and medical physicists have published Guidelines reporting parameters useful to quantify the radiation output and to assess patient dose., Conclusions: Our research revealed that there is not a shared interpretation of patient exposure information to be included in radiological report. Nevertheless, according to scientific community, authors believe that the exposure is the most appropriate information that could be included in radiological report. Alternatively, but with more expensiveness, a risk index based on effective dose could be used. Moreover, the systematic exposure information recorded could be useful for dose estimates of population from medical exposure.

When Congress passed HIPAA, it did not intend to constrain public health's data sharing in the same way as clinical or payers. In fact, HIPAA recognizes data sharing with public health as a matter of national priority and shields this function from its reach. However, a health department may offer services that bring it within HIPAA's purview, such as running a Children's Health Insurance Program or a laboratory that bills electronically. When this is the case, HIPAA requires all information and departments be subject to HIPAA unless the public health authority chooses to hybridize. Health departments might re-assess their coverage and elect to become a hybrid entity, thereby restricting HIPAA to only where required and removing barriers to information sharing with communities.

The following Article discusses the extent to which the constitutional right to informational privacy protects medical data from improper acquisition or dissemination by state agents. Part I provides background on Whalen v. Roe , the Supreme Court case that has been understood to establish the right to informational privacy. Part I also discusses the variations across the circuit courts as to what medical information is afforded protection by the right. Part II analyzes the well-established approaches adopted by the Second and Third Circuits as they present opposing interpretations of Whalen , one wholly protecting medical information and the other protecting scarcely any. Finally, Part III explains why the Supreme Court and courts that have yet to adopt a uniform approach should follow the Third Circuit and constitutionally protect all medical information from improper government acquisition or dissemination. Part III also argues for an amendment to the Privacy Act to provide individuals whose medical conditions are not afforded protection under the Constitution an alternative remedy., (Copyright by Cleveland State University.)

Background: Healthcare-associated infections are one of the most serious Public Health concern, as they prolong the length of hospitalization, reduce the quality of life, and increase morbidity and mortality. Despite they are not completely avoidable, the number of healthcare-associated infections related to negligence claims has risen over the last years, contributing to remarkable economic and reputation losses of Healthcare System., Methods: In this regard, several studies suggested a key role of medical records quality in determining medical care process, risk management and preventing liability. Clinical documentation should be able to demonstrate that clinicians met their duty of care and did not compromise patient's safety., Results: Therefore, it has a key role in assessing healthcare workers' liability in malpractice litigation. Our risk management experience has confirmed the role of medical records accuracy in preventing hospital liability and improving the quality of medical care., Conclusion: In the presented healthcare-associated infections cases, evidence-based and guidelinesbased practice, as well as a complete/incomplete medical record, have shown to significantly affect the verdict of the judicial court and inclusion/exclusion of hospital liability in healthcare-associated infections related claims., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

The documentation of immigration status in patient records poses a challenge to clinicians. On one hand, recording this social determinant of health can facilitate continuity of care and improved communication among clinicians. On the other, it might expose patients or their family members to immediate and unforeseen risks, such as being stigmatized and discriminated against by nonimmigrant-friendly clinicians or being exposed to immigration enforcement if staff contact immigration officials in violation of patient confidentiality. Patients may raise concerns about the purpose and risks of such documentation alongside fears about potential data sharing and violations of privacy and confidentiality. This commentary explores clinicians' options for documenting immigration status within the context of ethical, legal, and historical considerations in caring for stigmatized populations in changing political landscapes., (© 2019 American Medical Association. All Rights Reserved.)

Insights into the incidence and survival of cancer, the influence of lifestyle and environmental factors and the interaction of treatment regimens with outcomes are hugely dependent on observational research, patient data derived from the healthcare system and from volunteers participating in cohort studies, often non-selective. Since 25th May 2018, the European General Data Protection Regulation (GDPR) applies to such data. The GDPR focusses on more individual control for data subjects of 'their' data. Yet, the GDPR was preceded by a long debate. The research community participated actively in that debate, and as a result, the GDPR has research exemptions as well. Some of those apply directly; other exemptions need to be implemented into national law. Those exemptions will be discussed together with a general outline of the GDPR. I propose a substantive definition of research-absent in the GDPR-which can warrant its special status in the GDPR. The debate is not over yet. Most legal texts exhibit ambiguity and are interpreted against a background of values. In this case, those could be subsumed under informational self-determination versus solidarity and the deeper meaning of autonomy. Values will also guide national implementation and their interpretation. The value of individual control or informational self-determination should be balanced by nuanced visions about our mutual dependency in healthcare, as an ever-learning system, especially in the European solidarity-based healthcare systems. Good research governance might be a way forward to escape the consent or anonymise dichotomy., (Copyright © 2018 The Author. Published by Elsevier Ltd.. All rights reserved.)

Importance: Although federal law has long promoted patients' access to their protected health information, this access remains limited. Previous studies have demonstrated some issues in requesting release of medical records, but, to date, there has been no comprehensive review of the challenges that exist in all aspects of the request process., Objective: To evaluate the current state of medical records request processes of US hospitals in terms of compliance with federal and state regulations and ease of patient access., Design, Setting, and Participants: A cross-sectional study of medical records request processes was conducted between August 1 and December 7, 2017, in 83 top-ranked US hospitals with independent medical records request processes and medical records departments reachable by telephone. Hospitals were ranked as the top 20 hospitals for each of the 16 adult specialties in the 2016-2017 US News & World Report Best Hospitals National Rankings., Exposures: Scripted interview with medical records departments in a single-blind, simulated patient experience., Main Outcomes and Measures: Requestable information (entire medical record, laboratory test results, medical history and results of physical examination, discharge summaries, consultation reports, physician orders, and other), formats of release (pick up in person, mail, fax, email, CD, and online patient portal), costs, and request processing times, identified on medical records release authorization forms and through telephone calls with medical records departments., Results: Among the 83 top-ranked US hospitals representing 29 states, there was discordance between information provided on authorization forms and that obtained from the simulated patient telephone calls in terms of requestable information, formats of release, and costs. On the forms, as few as 9 hospitals (11%) provided the option of selecting 1 of the categories of information and only 44 hospitals (53%) provided patients the option to acquire the entire medical record. On telephone calls, all 83 hospitals stated that they were able to release entire medical records to patients. There were discrepancies in information given in telephone calls vs on the forms between the formats hospitals stated that they could use to release information (69 [83%] vs 40 [48%] for pick up in person, 20 [24%] vs 14 [17%] for fax, 39 [47%] vs 27 [33%] for email, 55 [66%] vs 35 [42%] for CD, and 21 [25%] vs 33 [40%] for online patient portals), additionally demonstrating noncompliance with federal regulations in refusing to provide records in the format requested by the patient. There were 48 hospitals that had costs of release (as much as $541.50 for a 200-page record) above the federal recommendation of $6.50 for electronically maintained records. At least 6 of the hospitals (7%) were noncompliant with state requirements for processing times., Conclusions and Relevance: The study revealed that there are discrepancies in the information provided to patients regarding the medical records release processes and noncompliance with federal and state regulations and recommendations. Policies focused on improving patient access may require stricter enforcement to ensure more transparent and less burdensome medical records request processes for patients.

Multiple guidelines and legal precedents have established the radiologist's duty to inform clinicians directly of critical findings, or findings that will greatly impact patient health in a timely manner [1]. While the number one cause for radiology malpractice cases is misdiagnosis, the literature shows a growing portion of lawsuits surrounding breakdowns in communication between radiologists and ordering providers [2,3]. As such, a review of guidelines related to the communication of imaging results is warranted. We will describe and provide our perspective on results communication as well as attempt to further define ideal communication practices in healthcare scenarios that fall outside of normal cases., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objectives:  To assess the current health data access and disclosure environment for potential privacy-protecting mechanisms that enable legitimate use of personal health information while preserving the rights of individuals. To identify the gaps and challenges between increasing requests and expanding uses of such information and the regulations, technologies, and management practices that permit appropriate access and disclosure while guarding against harmful misuse of such information., Methods:  A scoping literature review focused on (1) regulations affecting access and disclosure of personal health information, (2) the uses of health information that challenge access and disclosure boundaries, and (3) privacy management practices that may help mitigate gaps in protecting patient privacy., Results:  Countries and jurisdictions are developing laws, regulations, and public policies to balance the privacy rights of individuals and the unprecedented opportunities to advance health and health care through expanded uses of health data. Regulations and guidance are evolving, but they are outpaced by the increasing demand for and the challenges of managing access and disclosure. Mechanisms such as consent and authorization may not always be adequate. Mechanisms that advance principled stewardship are more important than ever., Conclusions:  Access and disclosure management are important dimensions of privacy management practices. This is a volatile period in which diverging public policies may reveal how best to balance access and disclosure of personal health information by individuals and by institutional custodians of the information. Approaches to access and disclosure management, including the roles of individuals, should be a focus for research and study in the years ahead., Competing Interests: Disclosure The authors report no conflicts of interest in this work., (Georg Thieme Verlag KG Stuttgart.)

Background: The secondary use of health data for research raises complex questions of privacy and governance. Such questions are ill-suited to opinion polling where citizens must choose quickly between multiple-choice answers based on little information., Objective: The aim of this project was to extend knowledge about what control informed citizens would seek over the use of health records for research after participating in a deliberative process using citizens' juries., Methods: Two 3-day citizens' juries, of 17 citizens each, were convened to reflect UK national demographics from 355 eligible applicants. Each jury addressed the mission "To what extent should patients control access to patient records for secondary use?" Jurors heard from and questioned 5 expert witnesses (chosen either to inform the jury, or to argue for and against the secondary use of data), interspersed with structured opportunities to deliberate among themselves, including discussion and role-play. Jurors voted on a series of questions associated with the jury mission, giving their rationale. Individual views were polled using questionnaires at the beginning and at end of the process., Results: At the end of the process, 33 out of 34 jurors voted in support of the secondary use of data for research, with 24 wanting individuals to be able to opt out, 6 favoring opt in, and 3 voting that all records should be available without any consent process. When considering who should get access to data, both juries had very similar rationales. Both thought that public benefit was a key justification for access. Jury 1 was more strongly supportive of sharing patient records for public benefit, whereas jury 2 was more cautious and sought to give patients more control. Many jurors changed their opinion about who should get access to health records: 17 people became more willing to support wider information sharing of health data for public benefit, whereas 2 moved toward more patient control over patient records., Conclusions: The findings highlight that, when informed of both risks and opportunities associated with data sharing, citizens believe an individual's right to privacy should not prevent research that can benefit the general public. The juries also concluded that patients should be notified of any such scheme and have the right to opt out if they so choose. Many jurors changed their minds about this complex policy question when they became more informed. Many, but not all, jurors became less skeptical about health data sharing, as they became better informed of its benefits and risks., (©Mary P Tully, Kyle Bozentko, Sarah Clement, Amanda Hunn, Lamiece Hassan, Ruth Norris, Malcolm Oswald, Niels Peek. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 28.03.2018.)

Recently, new laws on the handling of personal data have been published. Physicians should know them, since the information they obtain from the patient has been subject to what is therein established. To harmonize medical activity with these provisions, it is necessary to review the current legal framework. After this analysis, we observed that data the doctor registers in the medical record in the form of opinions or technical observations directed to other health professionals are not included. We consider this information should be protected the same way as that of the patient, in order to give legal certainty to the right of doctors to the discretion and confidentiality established in the "prescriptive freedom"., (Copyright: © 2018 SecretarÍa de Salud.)

The Law on the Modernization of our Health System passed in 2016 exteds the scope of the medical secrecy by creating the patients' shared health record. All health professionnals involved in the care pathway have an access to all recorded information. The patient can access to it via a dedicated Internet website. The implementing decrees of this facility determine the modalities to share the information and frame the creation of this automated processing of personal data. At last, this law creates an open and secure access to helath data in the interest of collectivity. This open data in health is placed under the governance of the Health Data National Institute.

Social workers are held to many ethical obligations regarding patients including maintaining patient confidentiality and staying up to date on confidentiality laws, statutes, and regulations. As the landscape of health care continues to change, including the increased use of technology to maintain patient records, highlights this need. The changes in the regulations on confidentiality of those who are receiving substance use treatment, 42 CFR Part 2, are presented. The other regulations and laws covered include HIPAA, HITECH, and the ACA. This includes the changes that have taken place, how to be compliant, and which to follow when.

The Health Quality Improvement Partnership has launched a guide on how information governance laws and principles apply to the use of personal data in local or regional multi-agency healthcare quality improvement studies, such as clinical audits, productivity reviews, intervention testing and service evaluation.

All organisations that provide NHS or adult social care are legally required to follow the Accessible Information Standard, which aims to ensure that people with a disability, impairment or sensory loss are provided with information they can read or understand easily and with support to help them communicate effectively with health and social care services.