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Dynamic consent (DC) was originally developed in response to challenges to the informed consent process presented by participants agreeing to ‘future research’ in biobanking. In the past 12 years, it has been trialled in a number of different projects, and examined as a new approach for consent and to support patient engagement over time. There have been significant societal shifts during this time, namely in our reliance on digital tools and the use of social media, as well as a greater appreciation of the integral role of patients in biomedical research. This paper reflects on the development of DC to understand its importance in an age where digital health is becoming the norm and patients require greater oversight and control of how their data may be used in a range of settings. As well as looking back, it looks forwards to consider how DC could be further utilised to enhance the patient experience and address some of the inequalities caused by the digital divide in society.

The adoption of electronic health records (EHRs) and electronic medical records (EMRs) has been slow in the mental health context, partly because of concerns regarding the collection of sensitive information, the standardization of mental health data, and the risk of negatively affecting therapeutic relationships. However, EHRs and EMRs are increasingly viewed as critical to improving information practices such as the documentation, use, and sharing of information and, more broadly, the quality of care provided. This paper aims to undertake a scoping review to explore the impact of EHRs on information practices in mental health contexts and also explore how sensitive information, data standardization, and therapeutic relationships are managed when using EHRs in mental health contexts. We considered a scoping review to be the most appropriate method for this review because of the relatively recent uptake of EHRs in mental health contexts. A comprehensive search of electronic databases was conducted with no date restrictions for articles that described the use of EHRs, EMRs, or associated systems in the mental health context. One of the authors reviewed all full texts, with 2 other authors each screening half of the full-text articles. The fourth author mediated the disagreements. Data regarding study characteristics were charted. A narrative and thematic synthesis approach was taken to analyze the included studies' results and address the research questions. The final review included 40 articles. The included studies were highly heterogeneous with a variety of study designs, objectives, and settings. Several themes and subthemes were identified that explored the impact of EHRs on information practices in the mental health context. EHRs improved the amount of information documented compared with paper. However, mental health-related information was regularly missing from EHRs, especially sensitive information. EHRs introduced more standardized and formalized documentation practices that raised issues because of the focus on narrative information in the mental health context. EHRs were found to disrupt information workflows in the mental health context, especially when they did not include appropriate templates or care plans. Usability issues also contributed to workflow concerns. Managing the documentation of sensitive information in EHRs was problematic; clinicians sometimes watered down sensitive information or chose to keep it in separate records. Concerningly, the included studies rarely involved service user perspectives. Furthermore, many studies provided limited information on the functionality or technical specifications of the EHR being used. We identified several areas in which work is needed to ensure that EHRs benefit clinicians and service users in the mental health context. As EHRs are increasingly considered critical for modern health systems, health care decision-makers should consider how EHRs can better reflect the complexity and sensitivity of information practices and workflows in the mental health context.

Patients are increasingly being provided with access to their electronic health records. However, in mental health care contexts, concerns have been raised due to a perception that such access would pose risks to patients, third parties, and the therapeutic relationship. These perceived risks may affect the information practices of health care professionals (HCPs) and patients, such as how they document, share, and use information in mental health care services with a patient-accessible electronic health record (PAEHR). Although there is growing research interest in PAEHRs, no study has specifically examined how they impact information practices. Understanding the impacts on information practices may help explain other outcomes of implementing PAEHRs and inform their design. This scoping review aimed to explore the research on PAEHRs in mental health care contexts and how PAEHRs affect information practices of HCPs and patients in this context. A scoping review was considered the most appropriate method due to the relatively recent adoption of PAEHRs in mental health care contexts and the heterogeneous nature of the evidence base. A comprehensive search of electronic databases was conducted for original empirical studies that described the use of PAEHRs or associated systems in mental health care contexts. One author reviewed all full texts, with 3 other authors reviewing a subset of studies. The study characteristics and findings were documented, and a thematic synthesis and textual narrative analysis were used to develop descriptive and analytical themes that addressed the research questions. A total of 66 studies were considered eligible and included in the analysis. The impact of PAEHRs on information practices in mental health care contexts included the following: (1) they may change how HCPs document patient information, including a reduction in detail and a focus on information perceived by HCPs as objective rather than subjective; (2) they may negatively impact workflows due to changes in documentation practices and limited guidance for HCPs on how to use PAEHRs; and (3) they may contribute to improved communication between HCPs and patients, including constructive disagreements regarding what is documented in the health record. The changes to HCP information practices were influenced by a concern for the therapeutic relationship and patient safety. Furthermore, PAEHRs supported new information practices for patients, such as using their PAEHR to prepare for clinical encounters. We have identified several ways in which PAEHRs shape the information practices of HCPs and patients in the mental health context. These findings can inform the design of PAEHRs to promote information practices that contribute to improving the quality of mental health care. Further research is necessary to understand how changes in information practices due to the implementation of PAEHRs impact clinical outcomes and patient experiences of care.

The complexities of the informed consent process for participating in research in genomic medicine are well-documented. Inspired by the potential for Dynamic Consent to increase participant choice and autonomy in decision-making, as well as the opportunities for ongoing participant engagement it affords, we wanted to trial Dynamic Consent and to do so developed our own web-based application (web app) called CTRL (control). This paper documents the design and development of CTRL, for use in the Australian Genomics study: a health services research project building evidence to inform the integration of genomic medicine into mainstream healthcare. Australian Genomics brought together a multi-disciplinary team to develop CTRL. The design and development process considered user experience; security and privacy; the application of international standards in data sharing; IT, operational and ethical issues. The CTRL tool is now being offered to participants in the study, who can use CTRL to keep personal and contact details up to date; make consent choices (including indicate preferences for return of results and future research use of biological samples, genomic and health data); follow their progress through the study; complete surveys, contact the researchers and access study news and information. While there are remaining challenges to implementing Dynamic Consent in genomic research, this study demonstrates the feasibility of building such a tool, and its ongoing use will provide evidence about the value of Dynamic Consent in large-scale genomic research programs.

There have been suggestions that electronic health records (EHRs) should be expanded beyond clinical mental health care services to a broader array of care services that support mental health service users, which we call an integrated electronic care record (IECR). Previous research has considered service users' general views on information being stored and shared via an EHR. However, little consideration has been given to service users' attitudes toward how EHRs should be used in the provision of care or the concept of an IECR. This study aimed to understand mental health care service users' perspectives on an IECR and how it should be used in practice when receiving care. Ten people with lived experience of accessing multiple services in Australia's mental health care system were provided with 2 vignettes that depicted fictional service users making decisions about an IECR. Participants were asked to respond to several scenarios that the fictional service users might experience in their journey through the mental health care system with an IECR. Participants provided written responses and took part in a semistructured interview to discuss their responses. An interpretative phenomenological analysis was undertaken, which led to 5 major themes and 15 subthemes being developed. Service users wanted an IECR that they had control over, supported them as equal partners in their care, and contributed toward more collaborative and proactive mental health care. However, participants were concerned that care professionals' perspectives would be privileged in the IECR and overshadow service users' needs. Participants also had concerns that stigmatizing and discriminatory information documented in their IECR would negatively impact their interactions with the mental health care system and their access to care. Participants saw value in an IECR bringing together information to support collaborative and proactive care. However, participants thought that the benefits of the IECR had to be balanced with potential risks to their privacy. Participants thought that the IECR should contain only information relevant to their care and should be shared only with relevant care professionals. There were concerns that service users might lack the skills, resources, and information required to manage their IECR. An IECR has the potential to fill the gaps in an increasingly complex and fragmented mental health care system but risks entrenching service users' experiences of stigma and discrimination unless service users are meaningfully involved in their IECR.

Dynamic consent (DC) is an approach to consent that enables people, through an interactive digital interface, to make granular decisions about their ongoing participation. This approach has been explored within biomedical research, in fields such as biobanking and genomics, where ongoing contact is required with participants. It is posited that DC can enhance decisional autonomy and improve researcher–participant communication. Currently, there is a lack of evidence about the measurable effects of DC-based tools. This article outlines a framework for DC evaluation and reporting. The article draws upon the evidence for enhanced modes of informed consent for research as the basis for a logic model. It outlines how future evaluations of DC should be designed to maximize their quality, replicability, and relevance based on this framework. Finally, the article considers best-practice for reporting studies that assess DC, to enable future research and implementation to build upon the emerging evidence base.

'Digital Mega-Studies' are entirely or extensively digitised, longitudinal, population-scale initiatives, collecting, storing, and making available individual-level research data of different types and from multiple sources, shaped by technological developments and unforeseeable risks over time. The Australian 'Gen V' project exemplifies this new research paradigm. In 2019, we undertook a multidisciplinary, multi-stakeholder process to map Digital Mega-Studies' key characteristics, legal and governance challenges and likely solutions. We conducted large and small group processes within a one-day symposium and directed online synthesis and group prioritisation over subsequent weeks. We present our methods (including elicitation, affinity mapping and prioritisation processes) and findings, proposing six priority governance principles across three areas—data, participation, trust—to support future high-quality, large-scale digital research in health.

Dynamic Consent (DC) is both a model and a specific web-based tool that enables clear, granular communication and recording of participant consent choices over time. The DC model enables individuals to know and to decide how personal research information is being used and provides a way in which to exercise legal rights provided in privacy and data protection law. The DC tool is flexible and responsive, enabling legal and ethical requirements in research data sharing to be met and for online health information to be maintained. DC has been used in rare diseases and genomics, to enable people to control and express their preferences regarding their own data. However, DC has never been explored in relationship to historical collections of bioscientific and genetic heritage or to contexts involving Aboriginal and Torres Strait Islander people (First Peoples of Australia). In response to the growing interest by First Peoples throughout Australia in genetic and genomic research, and the increasing number of invitations from researchers to participate in community health and wellbeing projects, this article examines the legal and ethical attributes and challenges of DC in these contexts. It also explores opportunities for including First Peoples' cultural perspectives, governance, and leadership as a method for defining (or redefining) DC on cultural terms that engage best practice research and data analysis as well as respect for meaningful and longitudinal individual and family participation.

The volume, variety and velocity of data available to companies about their employees is already significant and likely to increase. Employers hold data about employees that could be used to explore the relationship between workplace practice in their organisation and risks to employee health. However, there is significant uncertainty about whether employers subject to English law are permitted to use this data for this purpose, and even whether they may be under a legal obligation to do so. In this article, the question of whether employers are legally permitted or legally obliged to use employee data to identify associations between workplace practice and risk to employee health is answered through an analysis of two spheres of English Law: data protection law, and health and safety law. The authors establish a hypothetical case study concerning a company that wishes to use employee data in this way, to illuminate a set of detailed legal issues. In particular, the question of whether a reasonable and prudent employer is under an obligation under health and safety law to use the data and analytic tools at his or her disposal to assess risk and inform his or her actions is considered. Also addressed is the question of whether such processing would satisfy the data protection law principles of “lawful, fair, and transparent” processing and that of “purpose limitation”. A complex picture emerges. The analysis reveals that data protection legislation may not support a trend towards the re-use of employee data to enhance workplace health and safety; nor is there currently a clear mandate that responsible employers use data in this way. The line between useful insight into workplace practices and intrusion into employees’ privacy remains blurred.

Future Health Today (FHT) is a program integrated with electronic medical record (EMR) systems in general practice and comprises (1) a practice dashboard to identify people at risk of, or with, chronic disease who may benefit from intervention; (2) active clinical decision support (CDS) at the point of care; and (3) quality improvement activities. One module within FHT aims to facilitate cardiovascular disease (CVD) risk reduction in people with chronic kidney disease (CKD) through the recommendation of angiotensin-converting enzyme inhibitor inhibitors (ACEI), angiotensin receptor blockers (ARB), or statins according to Australian guidelines (defined as appropriate pharmacological therapy). This study aimed to determine if the FHT program increases the proportion of general practice patients with CKD receiving appropriate pharmacological therapy (statins alone, ACEI or ARB alone, or both) to reduce CVD risk at 12 months postrandomization compared with active control (primary outcome). General practices recruited through practice-based research networks in Victoria and Tasmania were randomly allocated 1:1 to the FHT CKD module or active control. The intervention was delivered to practices between October 4, 2021, and September 30, 2022. Data extracted from EMRs for eligible patients identified at baseline were used to evaluate the trial outcomes at the completion of the intervention period. The primary analysis used an intention-to-treat approach. The intervention effect for the primary outcome was estimated with a marginal logistic model using generalized estimating equations with robust SE. Overall, of the 734 eligible patients from 19 intervention practices and 715 from 21 control practices, 82 (11.2%) and 70 (9.8%), respectively, had received appropriate pharmacological therapy (statins alone, ACEI or ARB alone, or both) at 12 months postintervention to reduce CVD risk, with an estimated between-trial group difference (Diff) of 2.0% (95% CI -1.6% to 5.7%) and odds ratio of 1.24 (95% CI 0.85 to 1.81; P=.26). Of the 470 intervention patients and 425 control patients that received a recommendation for statins, 61 (13%) and 38 (9%) were prescribed statins at follow-up (Diff 4.3%, 95% CI 0 to 8.6%; odds ratio 1.55, 95% CI 1.02 to 2.35; P=.04). There was no statistical evidence to support between-group differences in other secondary outcomes and general practice health care use. FHT harnesses the data stored within EMRs to translate guidelines into practice through quality improvement activities and active clinical decision support. In this instance, it did not result in a difference in prescribing or clinical outcomes except for small changes in statin prescribing. This may relate to COVID-19-related disruptions, technical implementation challenges, and recruiting higher performing practices to the trial. A separate process evaluation will further explore factors impacting implementation and engagement with FHT. ACTRN12620000993998; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380119.