Experts reflecting on the duty to recontact patients and research participants; why professionals should take the lead in developing guidelines.

Sequencing technology is increasing the scale of information that could benefit patients who have been tested in the past. This raises the question whether professionals have a duty to recontact such patients or their families. There is currently no clear basis for a legal duty to recontact, and professional guidelines are limited. We conducted interviews with 14 senior professionals from the Netherlands and UK to obtain a range of opinions on what obligations are estimated to be possible or desirable. There was (near) consensus that a lack of resources currently inhibits recontacting in clinical practice, that recontacting is less desirable in research, that information on recontacting should be part of informed consent, and that a legal duty should follow professional standards. There was a diversity of opinions on the desirability of a more systematic approach, potential obligations in hybrid clinical-research projects, and who should bear responsibility for seeking updates. Based on the literature, legal framework and these interviews, we conclude that a general duty to recontact is unlikely, but that in specific circumstances a limited duty may apply if the benefit to the individual is significant and the burden on professionals not too extensive. The variation in opinion demonstrates that further deliberations are desirable. The development of guidelines-a process the European Society of Human Genetics has begun-is important to ensure that the courts, in deciding a recontacting case, can take into account what professionals consider responsible standards in this field.

Facing internet fake-medicine and web para-pharmacy in the total absence of official recommendations from medical societies.

PURPOSE: Internet fake information, parapharmacy and counterfeit drugs are a market of hundreds of billion dollars. Misleading internet data decrease patients' compliance to medical care, promote use of questionable and detrimental practices, and jeopardize patient outcome. This is particularly harmful among cancer patients, especially when pain and nutritional aspects are considered. Provision of Web recommendations for the general audience (patients, relatives, general population) from official medical-providers might be useful to outweigh the detrimental internet information produced by non-medical providers. METHODS: 370 oncology and anesthesiology related societies were analyzed. Our objective was to evaluate the magnitude of web-recommendation for cancer cachexia and cancer pain for the general audience provided by official medical organizations' web sites at global level. RESULTS: Magnitude of web-recommendations at global level was surprisingly scant both for coverage and consistency. Seven official medical societies provided updated web-recommendation for cancer cachexia to their patients/family members, and 15 for cancer pain. Scantiness was unrelated by continent, developmental index, oncology tradition, economic-geographic area and society type scrutinized. CONCLUSIONS: Patients need expert advice when exposed to fake internet information largely dominated by paramedical market profits. In this era of "new media" the patients' net-education represents a new major educational challenge for medical societies.

What you say and what I want: Priorities for public health campaigning and initiatives in relation to dementia.

OBJECTIVE: To examine the overlap between priorities expressed by representatives from national and local campaigning organisations and the views of key voices in relation to dementia. METHODS: Semi-structured, in-depth telephone interviews were conducted with 19 representatives from campaigning organisations, including nine countries and six local community initiatives in Australia. Responses were categorised into nine priorities. Views were compared to the voices of people with dementia (n = 19), carers (n = 28), and health-care (n = 21), social work (n = 23) and service professionals (n = 20). RESULTS: Local groups prioritised user-led decision-making and community normalising agendas. National groups were influenced by service frameworks and increasing public awareness. Professional and carer groups focused on increasing understanding and communication skills while people with dementia valued being a normal part of society. CONCLUSION: Future campaigning should use both national and local approaches to changing social relations, through interpersonal connections, advocacy and social mobilisation, to promote a normalising approach to attitude change.

Construction of patients' position in Norway's Patients' Rights Act.

BACKGROUND: Since the adoption of the Universal Declaration of Human Rights by the United Nations in 1948, human rights as set out in government documents have gradually changed, with more and more power being transferred to individual. OBJECTIVES: The aim of this article is to analyze how the position of the patient in need of care is constructed in Norway's renamed and revised Patients' and Service Users' Rights Act (originally Patients' Rights Act, 1999) and published comments which accompanying this legislation from the Norwegian Ministry of Health and Care Service. RESEARCH DESIGN: A constructivist design was used, and Fairclough's critical discourse approach was adopted to analyze the text of the Patients' and Service Users' Rights Act and comments. FINDINGS: The analysis identified three discourses: (a) political discourse, containing ethical discourses about priority and economy, in which patients are constructed as powerless individuals; (b) expert discourse, containing a theme about patients' trust in the healthcare team and its knowledge, in which patients are constructed as helpless individuals lacking knowledge; and (c) patient participation and patient autonomy discourse, containing ethical discourses about decision-making, in which patients are constructed not only as individuals with needs and rights but also as "troublesome." CONCLUSION: Dominant paternalistic discourses in the legal text validate the power of medicine, the healthcare system, and heath personnel over the needs, rights, participation, and autonomy of the patient.

Upper Extremity Immobilization and Driving: Limitations and Liability.

Orthopaedic injuries of the upper extremity remain common, often requiring prolonged immobilization after surgical or nonsurgical management. Upper extremity immobilization often has a profound effect on a patient's daily life, including one's ability to safely operate a motor vehicle. Current literature on the safety of driving while immobilized is varied, although above-elbow immobilization of the upper extremity is generally thought to present a particular hazard to safe driving. Unfortunately, as common as this situation is, currently little to no guidance exists for patients, physicians, or lawmakers with regard to deciding whether a patient is safe to return to driving with upper extremity immobilization. Similar discord exists with the issue of patient and physician liability in such cases. In this review, we seek to present both historical precedent and a contemporary update of this complex, though a frequently encountered situation.

Enhancing Privacy Controls for Patients via a Selective Authentic Electronic Health Record Exchange Service: Qualitative Study of Perspectives by Medical Professionals and Patients.

BACKGROUND: Patients' privacy is regarded as essential for the patient-doctor relationship. One example of a privacy-enhancing technology for user-controlled data minimization on content level is a redactable signature. It enables users to redact personal information from signed documents while preserving the validity of the signature, and thus the authenticity of the document. In this study, we present end users' evaluations of a Cloud-based selective authentic electronic health record (EHR) exchange service (SAE-service) in an electronic health use case. In the use case scenario, patients were given control to redact specified information fields in their EHR, which were signed by their doctors with a redactable signature and transferred to them into a Cloud platform. They can then selectively disclose the remaining information in the EHR, which still bears the valid digital signature, to third parties of their choice. OBJECTIVE: This study aimed to explore the perceptions, attitudes, and mental models concerning the SAE-service of 2 user roles: signers (medical professionals) and redactors (patients with different technical knowledge) in Germany and Sweden. Another objective was to elicit usability requirements for this service based on the analysis of our investigation. METHODS: We chose empirical qualitative methods to address our research objective. Designs of mock-ups for the service were used as part of our user-centered design approach in our studies with test participants from Germany and Sweden. A total of 13 individual walk-throughs or interviews were conducted with medical staff to investigate the EHR signers' perspectives. Moreover, 5 group walk-throughs in focus groups sessions with (N=32) prospective patients with different technical knowledge to investigate redactor's perspective of EHR data redaction control were used. RESULTS: We found that our study participants had correct mental models with regard to the redaction process. Users with some technical models lacked trust in the validity of the doctor's signature on the redacted documents. Main results to be considered are the requirements concerning the accountability of the patients' redactions and the design of redaction templates for guidance and control. CONCLUSIONS: For the SAE-service to be means for enhancing patient control and privacy, the diverse usability and trust factors of different user groups should be considered.

Responsabilidad penal médica: consideraciones en la aplicación del principio del doble efecto / Medical Criminal Liability: considerations in the application of the principle of double effect

La responsabilidad médica en Chile contempla un espacio de discrecionalidad, en situaciones de peligro para la mujer durante el embarazo y en el tratamiento paliativo de pacientes terminales. En estos casos se presentan conceptos jurídicos indeterminados, en el ordenamiento jurídico chileno, que requieren de una propuesta interpretativa en consonancia con la protección del derecho a la vida, en actividades médicas que tengan por efecto colateral la muerte de personas inocentes (AU).

The chilean medical liability leaves a room of discretion in cases when a hazardous condition exists during the pregnancy or palliative care for those dying from a terminal disease. In such cases, the Chilean legal system presents undefined legal concepts. This concepts need to be in accordance with the promotion of the constitutional right to life, in medical cases where innocent people could die by side effect (AU).

Responsabilidad penal médica: consideraciones en la aplicación del principio del doble efecto / Medical Criminal Liability: considerations in the application of the principle of double effect

La responsabilidad médica en Chile contempla un espacio de discrecionalidad, en situaciones de peligro para la mujer durante el embarazo y en el tratamiento paliativo de pacientes terminales. En estos casos se presentan conceptos jurídicos indeterminados, en el ordenamiento jurídico chileno, que requieren de una propuesta interpretativa en consonancia con la protección del derecho a la vida, en actividades médicas que tengan por efecto colateral la muerte de personas inocentes (AU).

The chilean medical liability leaves a room of discretion in cases when a hazardous condition exists during the pregnancy or palliative care for those dying from a terminal disease. In such cases, the Chilean legal system presents undefined legal concepts. This concepts need to be in accordance with the promotion of the constitutional right to life, in medical cases where innocent people could die by side effect (AU).

Capacity to make decisions: providing the relevant information.

Richard Griffith, Senior Lecturer in Health Law at Swansea University, discusses the nurse's duty in relation to assessing the decision-making capacity of patients.

Abortion Bans, Doctors, and the Criminalization of Patients.

January 2018, the American College of Obstetrics and Gynecology issued a position statement opposing the punishment of women for self-induced abortion. To those unfamiliar with emerging trends in abortion in the United States and worldwide, the need for the declaration might not be apparent. Several studies suggest that self-induced abortion is on the rise in the United States. Simultaneously, prosecutions of pregnant women for behavior thought to harm the fetus are increasing. The ACOG statement responds to both trends by urging doctors to honor the integrity and confidentiality inherent in the doctor-patient relationship. Seen in the context of the larger battle over legal abortion, the statement has far broader implications. By acknowledging the role doctors play in enforcing pregnancy-related crimes, the ACOG position statement wisely anticipates the ways in which doctors will be implicated should access to legal abortion be further restricted. To understand the need for the ACOG directive, you must first understand that the story of what will happen if abortion becomes a crime in the United States is not to be found in history books; it is staring at us across our southern border.

APPLaUD: access for patients and participants to individual level uninterpreted genomic data.

BACKGROUND: There is a growing support for the stance that patients and research participants should have better and easier access to their raw (uninterpreted) genomic sequence data in both clinical and research contexts. MAIN BODY: We review legal frameworks and literature on the benefits, risks, and practical barriers of providing individuals access to their data. We also survey genomic sequencing initiatives that provide or plan to provide individual access. Many patients and research participants expect to be able to access their health and genomic data. Individuals have a legal right to access their genomic data in some countries and contexts. Moreover, increasing numbers of participatory research projects, direct-to-consumer genetic testing companies, and now major national sequencing initiatives grant individuals access to their genomic sequence data upon request. CONCLUSION: Drawing on current practice and regulatory analysis, we outline legal, ethical, and practical guidance for genomic sequencing initiatives seeking to offer interested patients and participants access to their raw genomic data.

Hymenoplasty and Muslim Patients: Islamic Ethico-Legal Perspectives.

BACKGROUND: Hymenoplasty, commonly called "revirginization," is a controversial procedure that pushes the scope of medical practice to satisfy cultural and/or religious "needs." AIM: To outline the sociocultural contexts underlying patient requests for hymenoplasty and present Islamic juridical views on the moral status of hymenoplasty for Muslim patients. METHODS: Narrative review of the extant bioethics literature and leading Islamic ethico-legal verdicts. OUTCOMES: We identified "Western" and Islamic bioethical debates on hymenoplasty and the critical concepts that underpin ethical justifications for and against the procedure. RESULTS: From a Western-ethics perspective, the life-saving potential of the procedure is weighed against the role of the surgeon in directly assisting in a deception and in indirectly promoting cultural practices of sexual inequality. From an Islamic bioethical vantage point, jurists offer two opinions. The first is that the surgery is always impermissible. The second is that although the surgery is generally impermissible, it can become licit when the risks of not having postcoital bleeding harm are sufficiently great. CLINICAL IMPLICATIONS: Patient requests for hymenoplasty should be approached by surgeons with a willingness to understand patients' social contexts and reasons for pursuing the procedure and are ethically justified by leading Islamic jurists in particular circumstances. STRENGTHS AND LIMITATIONS: This article presents emic and etic perspectives on hymenoplasty in Muslim patients, although our review of the Islamic bioethical stances might have missed some juridical opinions and important considerations. Further, Muslims, even devout ones, might not be beholden to Islamic juridical views on medical procedures and thus physicians should not make assumptions about the rationale for, and ethical views of, patients seeking hymenoplasty. CONCLUSION: This article provides critical insight into how Muslim patients, and Islamic jurists, evaluate the moral contexts of hymenoplasty. Bawany MH, Padela AI. Hymenoplasty and Muslim Patients: Islamic Ethico-Legal Perspectives. J Sex Med 2017;14:1003-1010.

De pacientes, médicos e historias clínicas / On patients, physicians and medical records

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Time to Improve Informed Consent for Dialysis: An International Perspective.

The literature reveals that current nephrology practice in obtaining informed consent for dialysis falls short of ethical and legal requirements. Meeting these requirements represents a significant challenge, especially because the benefits and risks of dialysis have shifted significantly with the growing number of older, comorbid patients. The importance of informed consent for dialysis is heightened by several concerns, including: (1) the proportion of predialysis patients and patients on dialysis who lack capacity in decision making and (2) whether older, comorbid, and frail patients understand their poor prognosis and the full implications to their independence and functional status of being on dialysis. This article outlines the ethical and legal requirements for a valid informed consent to dialysis: (1) the patient was competent, (2) the consent was made voluntarily, and (3) the patient was given sufficient information in an understandable manner to make the decision. It then considers the application of these requirements to practice across different countries. In the process of informed consent, the law requires a discussion by the physician of the material risks associated with dialysis and alternative options. We argue that, legally and ethically, this discussion should include both the anticipated trajectory of the illness and the effect on the life of the patient with particular regard to the outcomes most important to the individual. In addition, a discussion should occur about the option of a conservative, nondialysis pathway. These requirements ensure that the ethical principle of respect for patient autonomy is honored in the context of dialysis. Nephrologists need to be open to, comfortable with, and skillful in communicating this information. From these clear, open, ethically, and legally valid consent discussions, a significant dividend will hopefully flow for patients, families, and nephrologists alike.

[Cooperation according to French Law "hospital, patients, health and territories": Pharmacists' involvement in Aquitaine region]. / Missions de coopération introduites par la loi « hôpital, patients, santé et territoires ¼ : participation des pharmaciens d'officine en Aquitaine.

BACKGROUND: In 2009, the French Act "Hospital, Patients, Health and Territories" (loi "Hôpital, Patients, Santé et Territoires") reorganized the outpatient care pathway and defined missions aimed at improving cooperation between pharmaceutical and medical professionals. Five years later, we conducted a survey among community pharmacists in order to assess the appropriation of these missions and the way cooperation was implemented. We also aimed to investigate factors that could hamper or ease the development of these activities in order to identify actions needed to improve pharmacists' involvement. METHODS: In partnership with the local health authorities "Agence régionale de santé", we conducted a survey via an online questionnaire sent to pharmacy holders in July 2014 in Aquitaine region. Information was collected about the pharmacies, involvement in collaborative activities, and barriers to cooperation. RESULTS: Overall, 20% (249) of pharmacists responded to the survey. They owned predominantly rural pharmacies (46%) or neighborhood pharmacies (41%), with two pharmacists per pharmacy (48%). Regarding collaborative activities, the majority of pharmacists (78%) had conducted interviews with their patients taking vitamin K antagonist therapy and they were willing to continue (87%). The implication was less common concerning other actions such as referent pharmacist for nursing homes (19%) or activities relating to therapeutic educational programs for patients with chronic conditions (34%). The vast majority of respondents (85%) were not aware of opportunities to become a correspondent pharmacist. The main obstacles for engaging in these activities were the lack of time, lack of knowledge about these missions and the lack of remuneration. We identified differences in pharmacists' involvement in collaborative activities depending on selected characteristics of the pharmacies. CONCLUSION: The findings of this survey underlined pharmacists' acceptance of these missions and suggest that better information and appropriate remuneration could enhance commitment. Recent changes in the legal framework (establishment of "pharmaceutical fees", extension of the scope of pharmaceutical interviews) enable funding for collaborative practices between medical practitioners and pharmacists, thus encouraging better coordination in the patient care pathway.