Opening Act: Patients Given Broad Access to Their EHRs.

Starting April 5, physicians must be ready to electronically share with patients more of the information generated during office visits. This change comes thanks to "information blocking" rules that are part of the 21st Century Cures Act, passed by Congress in 2016 and put into regulation in 2020 by the U.S. Department of Health and Human Services' Office of the National Coordinator (ONC).

Understanding the response of mammography facilities to breast density notification.

BACKGROUND: State-specific breast density notification legislation requires that women undergoing mammography be informed about breast density, with variation among states. Because mammography facilities are among the main points of contact for women undergoing mammography, research is needed to understand how facilities communicate information on breast density, cancer risk, and supplemental screening to women. METHODS: A cross-sectional, 50-item, mailed survey of 156 American College of Radiology-certified mammography facilities in North Carolina was conducted in 2017 via the Tailored Design Method. Breast density notification practices, supplemental screening services, and patient educational materials were compared by supplemental screening availability via t tests and chi-square tests. RESULTS: All responding facilities (n = 94; 60.3% response rate) notified women of their breast density in the mammography results letter. Breast cancer risk assessments were performed by 36.2% of the facilities, with risk information communicated in the final radiology report for the referring provider to discuss with the woman (79.4%) or in the results letter (58.8%). Supplemental breast cancer screening was offered by 63.8% of the facilities, with use based on multiple factors, including recommendations from the referring physician (63.3%) or reading radiologist (63.3%), breast density (48.3%), other risk factors (48.3%), and patient request (40.0%). Although 75.0% of the facilities offered breast density educational materials, only 36.6% offered educational materials on supplemental screening. CONCLUSIONS: In a state with a breast density notification law, mammography facilities communicate breast density, cancer risk, and supplemental screening information to women through various approaches. When supplemental screening is offered, facilities use multiple decision-making criteria rather than breast density alone.

The Perils of Parity: Should Citizen Science and Traditional Research Follow the Same Ethical and Privacy Principles?

The individual right of access to one's own data is a crucial privacy protection long recognized in U.S. federal privacy laws. Mobile health devices and research software used in citizen science often fall outside the HIPAA Privacy Rule, leaving participants without HIPAA's right of access to one's own data. Absent state laws requiring access, the law of contract, as reflected in end-user agreements and terms of service, governs individuals' ability to find out how much data is being stored and how it might be shared with third parties. Efforts to address this problem by establishing norms of individual access to data from mobile health research unfortunately can run afoul of the FDA's investigational device exemption requirements.

Return of Results in Participant-Driven Research: Learning from Transformative Research Models.

Participant-driven research (PDR) is a burgeoning domain of research innovation, often facilitated by mobile technologies (mHealth). Return of results and data are common hallmarks, grounded in transparency and data democracy. PDR has much to teach traditional research about these practices and successful engagement. Recommendations calling for new state laws governing research with mHealth modalities common in PDR and federal creation of review mechanisms, threaten to stifle valuable participant-driven innovation, including in return of results.

Updating HIPAA for the electronic medical record era.

With advances in technology, patients increasingly expect to access their health information on their phones and computers seamlessly, whenever needed, to meet their clinical needs. The 1996 passage of the Health Insurance Portability and Accountability Act (HIPAA), modifications made by the Health Information Technology for Economic and Clinical Health Act (HITECH), and the recent 21st Century Cures Act (Cures) promise to make patients' health information available to them without special effort and at no cost. However, inconsistencies among these policies' definitions of what is included in "health information", widespread variation in electronic health record system capabilities, and differences in local health system policies around health data release have created a confusing landscape for patients, health care providers, and third parties who reuse health information. In this article, we present relevant regulatory history, describe challenges to health data portability and fluidity, and present the authors' policy recommendations for lawmakers to consider so that the vision of HIPAA, HITECH, and Cures may be fulfilled.

The introduction of electronic medical records in France: More progress during the second attempt.

To support care coordination, a national electronic medical record (DMP), has been created by law in 2004. Because of technical difficulties and delays during implementation, the project was entrusted to a dedicated technical agency in 2009. But 3 years later, only 160,000 DMPs had been opened contrary to the several million expected. Physicians criticized the technical and administrative burden, but the main factors highlighted were resistance to sharing information with patients and with other professionals. Failing to cross the critical threshold of users that gives value to the system, the project failed. After this first attempt, the project was entrusted by law to the national health insurance fund in 2016. The new policy was addressed to patients, professionals and software companies. The policy has allowed patients to independently access and modify their DMP data already in possession of the national public medical insurance, and has introduced financial incentives for physicians opening a DMP. As a result the deployment of DMPs has accelerated substantially: 350,000 new DMPs were opened in nine pilot departments within a year. If scaled-up to the entire country, this number would correspond to 4 million DMPs.

[Is psychiatry ready to let patients review their own files? Inventory of initial experiences]. / Is de psychiatrie klaar voor de meelezende patiënt? Inventarisatie van eerste ervaringen.

BACKGROUND: Dutch patients will be granted the right to digitally access their own medical records, an option already available to the patients at the University Medical Center Utrecht since 2015. AIM: To start a conversation about the development of readily accessible online patient records. METHODS Describe the experiences of a University department of psychiatry with an online patient portal, obtained through discussions and questionnaires. RESULTS: During the next few years three legal developments will enable patients to acquire direct, remote, digital access to their medical files. Immediate online review of medical records improves accessibility and empowers the patient. Some therapists experienced a change in patient interaction. Furthermore, during documentation psychiatrists took into account that patients could review the contents at a later point. CONCLUSION: Patients' accessibility of online records will influence the patient-therapist dynamic. More research on the patient perspective and a discussion among professionals are necessary to further streamline broad implementation of online patient portals.

Assessment of US Hospital Compliance With Regulations for Patients' Requests for Medical Records.

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.

Legal, Practical, and Ethical Considerations for Making Online Patient Portals Accessible for All.

Largely driven by the financial incentives of the HITECH Act's Meaningful Use program as part of federal US health care reform, access to portal Web sites has rapidly expanded, allowing many patients to view their medical record information online. Despite this expansion, there is little attention paid to the accessibility of portals for more vulnerable patient populations-especially patients with limited health literacy or limited English proficiency, and individuals with disabilities. We argue that there are potential legal mandates for improving portal accessibility (e.g., the Civil Rights and the Rehabilitation Acts), as well as ethical considerations to prevent the exacerbation of existing health and health care disparities. To address these legal, practical, and ethical considerations, we present standards and broad recommendations that could greatly improve the reach and impact of portal Web sites.

Managing data subject access requests.

The Data Protection Act 1998 requires district nurses to process personal patient data fairly and lawfully by keeping accurate, contemporaneous and secure records. Patients who have concerns about the accuracy of their record can seek access to the record under the 1998 Act. In this article, Richard Griffith considers the requirements for requesting and granting access to a patient to view and obtain a copy of their health record.