A survey on the current status and future perspective of informed consent management in the MIRACUM consortium of the German Medical Informatics Initiative
Research
Christopher Hampf, Martin Bialke, Lars Geidel, Albert Vass, Thomas Bahls, Romina Blasini, Arne Blumentritt, Martin Boeker, Christian Bruns, Burkhard Jandrig, Maximilian Fünfgeld, Philipp Heinrich, Torsten Leddig, Achim Michel-Backofen, Anna Pirkl, Michael Rautenberg, Fabian Simons, Dana Stahl, Hans-Ulrich Prokosch, Wolfgang Hoffmann
Translational Medicine Communications, 8 March 2021; 6(7)
Open Access
Abstract
Background
The consent management is an essential component for supporting the implementation of consents and withdrawals and thus, the realisation of patient’s rights. In MIRACUM, one of the four consortia of the Medical Informatics Initiative (MII), ten university hospitals intend to integrate the generic Informed Consent Service® (gICS) in their Data Integration Center (DIC). To provide a tool that supports the local workflows of the MIRACUM sites, the gICS should be improved.
Methods
We used three standardised questionnaires with 46 questions to elicit requirements from the ten sites. Each site answered the questions from the current and the desired future perspective. This made it possible to understand the individual processes at each site and it was possible to identify features and improvements that were generally necessary.
Results
The results of the survey were classified according to their impact on the gICS. Feature requests of new functionalities, improvements of already implemented functionalities and conceptual support for implementing processes were identified. This is the basis for an improved gICS release to support the ten sites’ individual consent management processes.
Conclusions
A release plan for the feature requests and improvements was coordinated with all sites. All sites have confirmed that the implementation of these features and enhancements will support their software-based consent management processes.

DynamiChain: Development of Medical Blockchain Ecosystem Based on Dynamic Consent System
Review
Tong Min Kim, Seo-Joon Lee, Dong-Jin Chang, Jawook Koo, Taenam Kim, Kun-Ho Yoon, In-Young Choi
Applied Science, 10 February 2021; 11(1612)
Open Access
Abstract
Although blockchain is acknowledged as one of the most important technologies to lead the fourth industrial revolution, major technical challenges regarding security breach and privacy issues remain. This issue is particularly sensitive in applied medical fields where personal health information is handled within the network. In addition, contemporary blockchain-converged solutions do not consider restricted medical data regulations that are still obstacles in many countries worldwide. This implies a crucial need for a system or solution that is suitable for the healthcare sector. Therefore, this article proposes the development of a dynamic consent medical blockchain system called DynamiChain, based on a ruleset management algorithm for handling health examination data. Moreover, medical blockchain-related studies were systematically reviewed to prove the novelty of DynamiChain. The proposed system was implemented in a scenario where the exercise management healthcare company provided health management services based on data obtained from the data provider’s hospital. The proposed research is envisioned to provide a widely compatible blockchain medical system that could be applied in future healthcare fields.

A Systematic Review of Blockchain for Consent Management
Review
Prasanth Varma Kakarlapudi, Qusay H. Mahmoud
Healthcare, 1 February 2021
Abstract
Blockchain technology was introduced through Bitcoin in a 2008 whitepaper by the mysterious Satoshi Nakamoto. Since its inception, it has gathered great attention because of its unique properties—immutability and decentralized authority. This technology is now being implemented in various fields such as healthcare, IoT, data management, etc., apart from cryptocurrencies. As it is a newly emerging technology, researchers and organizations face many challenges in integrating this technology into other fields. Consent management is one of the essential processes in an organization because of the ever-evolving privacy laws, which are introduced to provide more control to users over their data. This paper is a systematic review of Blockchain’s application in the field of consent and privacy data management. The review discusses the adaptation of Blockchain in healthcare, IoT, identity management, and data storage. This analysis is formed on the principles of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) and a process of systematic mapping review. We provide analysis of the development, challenges, and limitations of blockchain technology for consent management.

H3Africa Report on Informed Consent and Commercialisation
Ruth Chadwick, Patricia Marshall, Charmaine DM Royal
H3Africa Report, February 2021
Open Access
Background
…In light of the vast amount of genetic diversity in African populations, H3Africa provides an unparalleled research resource for the benefit of people in Africa and across the globe. Thus, the sharing of data is a guiding principle for H3Africa, and the translation of research findings to commercial products, resources, and services is consistent with its mission. Driven by a commitment to transparency and accountability, the H3Africa leadership convened a panel of experts (authors) to review the research ethics processes and practices being employed in the H3Africa Consortium projects with the aim of identifying gaps and making recommendations for improvements going forward with regard to commercialisation. Specifically, the panel was asked to review H3Africa consent documents and talk with key members of the Consortium, including members of the Ethics Working Group, to determine how H3Africa Consortium projects have implemented informed consent procedures for studies involving biobanking and the sharing of data and/or biospecimens…

Ethical issues in using ambient intelligence in health-care settings
Viewpoint
Nicole Martinez-Martin, Zelun Luo, Amit Kaushal, Ehsan Adeli, Albert Haque, Sara S Kelly, Sarah Wieten, Mildred K Cho, David Magnus, Li Fei-Fei, Kevin Schulman, Arnold Milstein
The Lancet Digital Health, 21 December 2020
Open Access
Summary
Ambient intelligence is increasingly finding applications in health-care settings, such as helping to ensure clinician and patient safety by monitoring staff compliance with clinical best practices or relieving staff of burdensome documentation tasks. Ambient intelligence involves using contactless sensors and contact-based wearable devices embedded in health-care settings to collect data (eg, imaging data of physical spaces, audio data, or body temperature), coupled with machine learning algorithms to efficiently and effectively interpret these data. Despite the promise of ambient intelligence to improve quality of care, the continuous collection of large amounts of sensor data in health-care settings presents ethical challenges, particularly in terms of privacy, data management, bias and fairness, and informed consent. Navigating these ethical issues is crucial not only for the success of individual uses, but for acceptance of the field as a whole.

Rethinking Patient Consent in the Era of Artificial Intelligence and Big Data
Feature Opinion
Amy L. Kotsenas, Patricia Balthazar, David Andrews, J. Raymond Geis, Tessa S. Cook
Journal of the American College of Radiology, 1 January 2021; 18(1) pp 180-184
Open Access
Excerpt
Electronic data allow health care workers and industry to analyze large data sets for population health and to develop artificial intelligence (AI) tools. Researchers may find patterns in the data to prevent disease, understand disease risk and cause, improve diagnosis, develop new treatments, improve patient safety, and evaluate health care policy. These new uses of massive amounts of patient data often result in retrospective data mining for purposes not anticipated when patients consented to allow their data to be used. Some propose that freely available data will ultimately benefit patients and the greater good. However, once data are freely available, users no longer control them, and the data may be used for any reason. It is fair to say that these data will be used by industry, and in health care organizations, in unanticipated ways that lead to financial gain, which may conflict with ethical standards for patient privacy and confidentiality. Perceiving data as a commodity to be used in any way that maximizes profit or income will lead to ethical lapses if clear policies and guidelines are not quickly established…

Ethical Issues in Consent for the Re-use of Data in Health Data Platforms
Alex McKeown, Miranda Mourby, Paul Harrison, Sophie Walker, Mark Sheehan, Ilina Singh
Science and Engineering Ethics, December 2020
Abstract
Data platforms represent a new paradigm for carrying out health research. In the platform model, datasets are pooled for remote access and analysis, so novel insights for developing better stratified and / or personalised medicine approaches can be derived from their integration. If the integration of diverse datasets enables development of more accurate risk indicators, prognostic factors, or better treatments and interventions, this obviates the need for the sharing and reuse of data; and a platform-based approach is an appropriate model for facilitating this. Platform-based approaches thus require new thinking about consent. Here we defend an approach to meeting this challenge within the data platform model, grounded in: the notion of ‘reasonable expectations’ for the reuse of data; Waldron’s account of ‘integrity’ as a heuristic for managing disagreement about the ethical permissibility of the approach; and the element of the social contract that emphasises the importance of public engagement in embedding new norms of research consistent with changing technological realities. While a social contract approach may sound appealing, however, it is incoherent in the context at hand. We defend a way forward guided by that part of the social contract which requires public approval for the proposal and argue that we have moral reasons to endorse a wider presumption of data reuse. However, we show that the relationship in question is not recognisably contractual and that the social contract approach is therefore misleading in this context. We conclude stating four requirements on which the legitimacy of our proposal rests.