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

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

Confidentiality in the Care of Adolescents: Policy Statement.

Confidentiality is an essential component of high-quality health care for adolescents and young adults and can have an impact on the health care experiences and health outcomes of youth. Federal and state laws, professional guidelines, and ethical standards provide a core framework for guidance in the implementation of confidentiality protections in clinical practice. This policy statement provides recommendations for pediatricians and other pediatric health care professionals, clinics, health systems, payers, and electronic health record developers to optimize confidentiality practices and protections for adolescents and young adults across the spectrum of care.

Ethical and social reflections on the proposed European Health Data Space.

The COVID-19 pandemic demonstrated the benefits of international data sharing. Data sharing enabled the health care policy makers to make decisions based on real-time data, it enabled the tracking of the virus, and importantly it enabled the development of vaccines that were crucial to mitigating the impact of the virus. This data sharing is not the norm as data sharing needs to navigate complex ethical and legal rules, and in particular, the fragmented application of the General Data Protection Regulation (GDPR). The introduction of the draft regulation for a European Health Data Space (EHDS) in May 2022 seeks to address some of these legal issues. If passed, it will create an obligation to share electronic health data for certain secondary purposes. While there is a clear need to address the legal complexities involved with data sharing, it is critical that any proposed reforms are in line with ethical principles and the expectations of the data subjects. In this paper we offer a critique of the EHDS and offer some recommendations for this evolving regulatory space.

Health Care AI and Patient Privacy-Dinerstein v Google.

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

Consideraciones normativas y legales del expediente clínico electrónico en odontología / Normative and legal considerations of the electronic clinical record in odontology

La elaboración del expediente clínico es una actividad rutinaria dentro del consultorio dental, éste es la materialización del acto médico, a tra- vés del cual se registra el estado de salud inicial del paciente, así como toda la información relativa al tratamiento recibido. Desde hace algunos años comenzó a promocionarse el expediente clínico electrónico como una herramienta alternativa y novedosa para elaborar este importante documento; sin embargo, la implementación de esta herramienta electrónica no ha podido lograrse en México, dada la gran cantidad de dudas que los odontólogos tienen respecto al conjunto de leyes y normas que regulan al expediente clínico, lo cual genera renuencia por parte de los odontólogos para utilizar esta modalidad de expediente dentro de su consulta diaria. El objetivo del presente artículo es realizar una revisión de la literatura, así como de las leyes y normas vigentes que regulan el expediente clínico en México para esclarecer así la viabilidad de implementarlo dentro del consultorio dental

The preparation of the electronic medical record is a routine activity in the dental office, this is the materialization of the medical act, through which the initial health status of the patient is recorded, as well as all the information related to the received treatment. A few years ago, the electronic clinical record began to be promoted as a novel alternative tool to prepare this important document, however, the implementation of this electronic tool has not been achieved in Mexico, given the large number of doubts that dentists have regarding the set of laws thar regulate the clinical record, which generates reluctance on the part of dentists to use this record modality within their daily consultation. The aim of this article is to carry out a review of the literature, as well as the current laws that regulate the clinical record in Mexico, in order to clarify the feasibility of implementing it within the dental office

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

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

Health Information Privacy, Protection, and Use in the Expanding Digital Health Ecosystem: A Position Paper of the American College of Physicians.

Technologic advancements and the evolving digital health landscape have offered innovative solutions to several of our health care system's issues as well as increased the number of digital interactions and type of personal health information that is generated and collected, both within and outside of traditional health care. This American College of Physicians' position paper discusses the state of privacy legislation and regulations, highlights existing gaps in health information privacy protections, and outlines policy principles and recommendations for the development of health information privacy and security protections that are comprehensive, transparent, understandable, adaptable, and enforceable. The principles and recommendations aim to improve on the privacy framework in which physicians have practiced for decades and expand similar privacy guardrails to entities not currently governed by privacy laws and regulations. The expanded privacy framework should protect personal health information from unauthorized, discriminatory, deceptive, or harmful uses and align with the principles of medical ethics, respect individual rights, and support the culture of trust necessary to maintain and improve care delivery.

Incidental Findings in the Trauma Population: Interdisciplinary Approach and Electronic Medical Record Reminder Association with Pre-Discharge Reporting and Medicolegal Risk.

BACKGROUND: Incidental findings (IFs) are reported in 20% or more of trauma CT scans. In addition to the importance of patient disclosure, there is considerable legal pressure to avoid missed diagnoses. We reported previously that 63.5% of IFs were disclosed before discharge and with 20% were nondisclosed. We initiated a multidisciplinary systemic plan to effect predischarge disclosure by synoptic CT reports with American College of Radiology recommended follow-up, electronic medical records discharge prompts, and provider education. STUDY DESIGN: Prospective observational series patients from November 2019 to February 2020 were included. Statistical analysis was performed with SPSS, version 21 (IBM Corp). RESULTS: Eight hundred and seventy-seven patients underwent 1 or more CT scans for the evaluation of trauma (507 were male and 370 were female). Mean age of the patients was 57 years (range 14 to 99 years) and 96% had blunt injury. In 315 patients, there were 523 IFs (1.7 per patient); the most common were lung (17.5%), kidney (13%), and liver (11%). Radiology report compliance rate was 84% (210 of 249 patients). There were 66 studies from outside facilities. Sixteen IFs were suspicious for malignancy. A total of 151 patients needed no follow-up and 148 patients needed future follow-up evaluation. Predischarge IF disclosure compliance rate was 90.1% (286 patients); 25 were post discharge. Four patients remained undisclosed. Compared with our previous report, clearer reporting and electronic medical records prompts increased predischarge disclosure from 63.5% to 90.1% (p < 0.01, chi-square test) and decreased days to notification from 29.5 (range 0 to 277) to 5.2 (range 0 to 59) (p < 0.01, Mann-Whitney U test). CONCLUSIONS: Timely, complete disclosure of IFs improves patient outcomes and reduces medicolegal risk. Collaboration among trauma, radiology, and information technology promotes improved disclosure in trauma populations.

A proposal for shoring up Federal Trade Commission protections for electronic health record-connected consumer apps under 21st Century Cures.

Under the 21st Century Cures Act and the Office of the National Coordinator for Health Information Technology (ONC) rule implementing its interoperability provisions, a patient's rights to easily request and obtain digital access to portions of their medical records are now supported by both technology and policy. Data, once directed by a patient to leave a Health Insurance Portability and Accountability Act-covered health entity and enter a consumer app, will usually fall under Federal Trade Commission oversight. Because the statutory authority of the ONC does not extend to health data protection, there is not yet regulation to specifically address privacy protections for consumer apps. A technologically feasible workflow that could be widely adopted and permissible under ONC's rule, involves using the SMART on FHIR OAuth authorization routine to present standardized information about app behavior. This approach would not bias the patient in a way that triggers penalties under information blocking provisions of the rule.

Mobile Point-of-Care Medical Photography: Legal Considerations for Health Care Providers.

Medical photographs have been used for decades to document clinical findings. The ease with which medical photographs can be captured and integrated into the electronic health record (EHR) has increased as digital cameras obviated the need for the film development process. Today, cameras integrated into smartphones allow for high-resolution images to be instantly uploaded and integrated into the EHR. With major EHR vendors offering mobile smartphone applications for the conduct of point-of-care medical photography, health care providers and institutions need to be aware of legal questions that arise in the conduct of medical photography. Namely, (1) what are the requirements for consent when taking medical photographs, and how may photographs be used after consent is obtained, (2) are medical photographs admissible as evidence in court, and (3) how should a provider respond to a request by a patient or parent requesting that a photograph be deleted from the medical record? Herein, we review relevant laws and legal cases in the context of accepted standards of medical practice pertaining to point-of-care medical photography. This review is intended to aid health care providers and institutions seeking to develop or revise policies regarding using a mobile application at their clinical practice.

Ethical and Legal Implications of Remote Monitoring of Medical Devices.

Policy Points Millions of life-sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user-downloaded smartphone applications to facilitate data relay to clinicians via manufacturer servers. Our analysis of health privacy laws indicates that most US patients may have little access to their own digital health data in the United States under the Health Insurance Portability and Accountability Act Privacy Rule, whereas the EU General Data Protection Regulation and the California Consumer Privacy Act grant greater access to device-collected data. Our normative analysis argues for consistently granting patients access to the raw data collected by their implantable devices. CONTEXT: Millions of life-sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user-downloaded smartphone applications to facilitate data relay to clinicians via manufacturer servers. Whether patients have either legal or normative claims to data collected by these devices, particularly in the raw, granular format beyond that summarized in their medical records, remains incompletely explored. METHODS: Using pacemakers and implantable cardioverter-defibrillators (ICDs) as a clinical model, we outline the clinical ecosystem of data collection, relay, retrieval, and documentation. We consider the legal implications of US and European privacy regulations for patient access to either summary or raw device data. Lastly, we evaluate ethical arguments for or against providing patients access to data beyond the summaries presented in medical records. FINDINGS: Our analysis of applicable health privacy laws indicates that US patients may have little access to their raw data collected and held by device manufacturers in the United States under the Health Insurance Portability and Accountability Act Privacy Rule, whereas the EU General Data Protection Regulation (GDPR) grants greater access to device-collected data when the processing of personal data falls under the GDPR's territorial scope. The California Consumer Privacy Act, the "little sister" of the GDPR, also grants greater rights to California residents. By contrast, our normative analysis argues for consistently granting patients access to the raw data collected by their implantable devices. Smartphone applications are increasingly involved in the collection, relay, retrieval, and documentation of these data. Therefore, we argue that smartphone user agreements are an emerging but potentially underutilized opportunity for clarifying both legal and ethical claims for device-derived data. CONCLUSIONS: Current health privacy legislation incompletely supports patients' normative claims for access to digital health data.