Data protection and ethics requirements for multisite research with health data: a comparative examination of legislative governance frameworks and the role of data protection technologies.

Personalised medicine can improve both public and individual health by providing targeted preventative and therapeutic healthcare. However, patient health data must be shared between institutions and across jurisdictions for the benefits of personalised medicine to be realised. Whilst data protection, privacy, and research ethics laws protect patient confidentiality and safety they also may impede multisite research, particularly across jurisdictions. Accordingly, we compare the concept of data accessibility in data protection and research ethics laws across seven jurisdictions. These jurisdictions include Switzerland, Italy, Spain, the United Kingdom (which have implemented the General Data Protection Regulation), the United States, Canada, and Australia. Our paper identifies the requirements for consent, the standards for anonymisation or pseudonymisation, and adequacy of protection between jurisdictions as barriers for sharing. We also identify differences between the European Union and other jurisdictions as a significant barrier for data accessibility in cross jurisdictional multisite research. Our paper concludes by considering solutions to overcome these legislative differences. These solutions include data transfer agreements and organisational collaborations designed to `front load' the process of ethics approval, so that subsequent research protocols are standardised. We also allude to technical solutions, such as distributed computing, secure multiparty computation and homomorphic encryption.

Personal genomics in Greece: an overview of available direct-to-consumer genomic services and the relevant legal framework.

BACKGROUND: This article provides an overview of direct-to-consumer (DTC) genomic services that are currently available in Greece and the legal framework within which they operate. METHODS: Here, we describe the landscape of the DTC genomic testing companies and laboratories by conducting a systematic Ιnternet search for relevant websites. We examine the existing legal framework regarding genetic testing in Greece by a review of present regulation. Although Greece does not have explicit legal provisions for DTC genomics, several other laws, including soft law mechanisms, create the broader legal framework within which DTC genomic services may exist. RESULTS/CONCLUSIONS: While the current legal framework creates a flexible environment that is conducive to DTC genomic operations, it is also ambiguous about the legality of some specific services. Given the growing DTC activity in Greece, we argue that it is important to both enforce compliance with existing law and clarify legal ambiguities that may risk limiting the power of legal protections that ought to be afforded to consumers.