The effective management of personal health data is critically challenged in the rapidly evolving landscape of health and research. It is important to strike a positive balance between facilitating access to personal health observations, protecting the privacy of citizens, instilling trust in the use of personal data and lowering inequity and disparities. This should certainly include the balance of personal protection and access, with availability of data to promote public health discovery and innovation. Lynch et al recognized this need to find consensus among Australian public stakeholders on aspects of genomic data governance models- the ways genomic data is stored, managed, shared and used [1]. They found that consent and control were essential to the focus group participants, for participants reflected on the accessibility of their data and the importance of clarity of data-use purpose. They expressed a need for a model or trustworthy body to regulate the storage, sharing, security and usability of data. Finally, financial responsibility for data storage raised concerns for inequity as well as organizations and individuals using data in ethically contentious ways to generate profit. The findings by Lynch et al do not only apply to the Australian Public perspectives, but recently Tommel et al. published similar findings from a Dutch and Belgian perspective [2]. Across Europe, Personal Health Data Space (PHDS) projects are under development aiming to establish patient-centered, interoperable data ecosystems balancing data access, control, and use for individual citizens to complement the research and commercial focus of the European Health Data Space provisions. Tommel et al.’s study explored healthcare users' and health care professionals' perspectives on personalized genomic medicine and PHDS solutions, specifically the Personal Genetic Locker (PGL). This included: (i) participants were interested in genomic information; (ii) participants valued data control, robust infrastructure, and sharing data with non-commercial stakeholders; (iii) autonomy was a central concern for all participants; (iv) institutional and interpersonal trust were highly significant for genomic medicine; and (v) participants encouraged the implementation of PHDSs since these instruments were thought to promote the use of genomic data and enhance patients' control over their data.
These issues all align to the General Data Protection Regulation (GDPR), while the GDPR regulates protection for citizens regarding the use of personal data, there is a trend back towards broad consent and enforcing data controllers to share data without a re-consenting process. However, this could lead to citizens losing trust in sharing their data if they are not engaged in the decision-making process and are not informed about how their data is used. Initiatives like the European Health Data Space, Genomic Data Infrastructure, European Health Data Evidence Network, and the European Joint Program on Rare Diseases are crucial in building human data infrastructure. National infrastructures such as the data infrastructure of the German Medical Informatics Initiative, the Dutch Health Research Infrastructure, and the Swiss Personal Health Network are also important. One of the countries that is frequently criticized (whether this is legitimized or not remains to be discussed) for its use of personal data in research is the USA, for its informed consent may not be as transparent as many think it should be. The primary driver of this concern could be the complexity of the regulations. The use and sharing of personal health data in the USA is governed by various federal and state laws, including the Health Insurance Portability and Accountability Act (HIPAA), which sets standards for the privacy and security of personal health information, and the Affordable Care Act (ACA), which includes provisions related to the sharing of health data for research purposes. Under HIPAA, healthcare providers and insurers must obtain patients' written consent before sharing their personal health data with third parties, except in certain circumstances, such as for treatment or payment purposes. Patients also have the right to access and request corrections to their own health data. In recent years, there has been growing US interest in using personal health data for research and public health purposes as well. To address concerns about privacy and security, various initiatives have been launched to promote the responsible sharing of health data, such as the Precision Medicine Initiative and the All of Us research program, the world’s largest and most diverse data set. Overall, the use and sharing of personal health data in the USA is a complex and evolving area, with important implications for privacy, security, and public health.
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