National Electronic Health Record Systems and Consent to Processing of Health Data in the European Union and Australia
Danuta Mendelson
Legal Tech and the New Sharing Economy, 13 December 2019; pp 83-99
Abstract
This study focuses on the single most important regulatory aspect of data processing, namely consent to data processing. It compares approaches to consent under the General Data Protection Regulation (EU 2016/679) of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data (and on the free movement of such) (GDPR) in the context of European Union (EU) national electronic health record (NEHR) schemes (also referred to as “national digital health networks”) with the approach of the Australian national health record scheme called My Health Record (MHR). The GDPR, subject to derogation in limited circumstances, is binding on all 27 EU member countries. Under Articles 168 (2) and (7) of the Treaty on the Functioning of the European Union (2007), while the EU has a duty to “encourage cooperation between the Member States…to improve the complementarity of their health services in cross-border areas,” the European Union Member States retain the power to manage their own health services. However, in doing so, subject to narrow derogations, the management of their NEHR systems must conform to the GDPR. The GDPR governs the processing of data in any form including data contained in national electronic health systems (European Commission Recommendation on a European Electronic Health Record exchange format (C(2019)800) of 6 February 2019… Given that, unlike the Australian MHR scheme, national electronic medical/health records systems of EU Member States are at different stages of development, and that derogations enable a measure of variance in compliance, individual European systems will not be discussed. Australia is a non-EU jurisdiction, and does not have the European Commission’s certificate of adequate level of data protection (GDPR Article 45 empowers the European Commission to determine whether a country outside the EU offers an adequate level of data protection, whether by its domestic legislation or of the international commitments it has entered into. For further discussion, see below). One of the reasons for the absence of certification might be the effectively non-consensual nature of the My Health Record system that administers, collects, stores, and provides access to health and clinical data of Australians.

Too Dense and Too Detailed: Evaluation of the Health Literacy Attributes of an Informed Consent Document
Vanessa W. Simonds, Dedra Buchwald
Journal of Racial and Ethnic Health Disparities, 10 December 2019
Abstract
The US government recently updated the Common Rule, a set of federal regulations to ensure the ethical conduct of human subjects research. The new regulations require that consent documents provide information that is clear and concise enough to enable truly informed consent. This study explores potential American Indian research participants’ understanding and perceptions of an example consent document, focusing on possible improvements to better serve the requirements of the revised Common Rule. Participants completed a survey that collected demographic data and measured health literacy, numeracy, and comprehension of the example document. Next, they participated in focus groups to answer open-ended questions regarding their views on the example document. We calculated mean scores and frequencies of response to analyze quantitative survey data and performed a qualitative thematic analysis of focus group transcripts. Results demonstrated that American Indian participants with relatively strong health literacy skills clearly understood key elements of the consent document, including the purpose of signing it, confidentiality, compensation, and whom to contact for questions. However, they were overwhelmed by details on research procedures and were concerned about the document’s layout. To make consent documents more readily comprehensible, participants recommended the addition of headings, bullets, graphics, and relevant pictures. They also recommended a two-step consent process, comprising a short introduction to the research project followed by a longer explanation of procedures. These results illustrate the potential advantages of community engagement in drafting consent materials. Health researchers would likely benefit from community recommendations like the ones we elicited as they design consent documents adherent to the revised Common Rule.