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RECOMMENDED REFORMS IN THE PRACTICE OF OBTAINING INFORMED CONSENT FOR SHARING MEDICAL AND HEALTH DATA
Shinto Teramoto1
1Kyushu University, Fukuoka, Japan

PAPER: 87/Laws/Regular (Oral) OS
SCHEDULED: 14:00/Mon. 21 Oct. 2024/Minos

ABSTRACT:

To facilitate the sharing of medical and health information across jurisdictions, harmonizing related practices appears to be essential. It is highly likely that governments and legal professionals will consider establishing international treaties or agreements for this purpose. However, it remains questionable whether they can effectively harmonize the actual practices of medical and healthcare professionals.

A more practical and swift approach, suitable for jurisdictions with diverse personal information protection laws, would involve implementing measures that ensure the collection of evidence demonstrating prior and express informed consent, and the ability for patients and other data subjects to withdraw consent. These measures should also aim to minimize the burden on both medical and healthcare service providers and the data subjects. Furthermore, if these measures become de facto standards—and ideally evolve into de jure standards—they would help domestic courts recognize practices compliant with these standards as lawful.

To design measures that face less resistance across various jurisdictions, efforts should be made to minimize conflicts with existing personal information protection legislation. A key aspect of this involves maintaining a straightforward informed consent process. Typically, this process includes disclosing the scope and purpose of using certain personal information and securing either implied or express consent from the data subject. The author suggests reforms in the practice of obtaining informed consent for sharing medical and health data, recommending the use of a common ITC platform to provide information and secure informed consent.

REFERENCES:
[1] Kaye, J., Whitley, E., Lund, D. et al. Dynamic consent: a patient interface for twenty-first century research networks. Eur J Hum Genet 23, 141–146 (2015). https://doi.org/10.1038/ejhg.2014.71
[2] Japan Association for Medical Informatics. (2021, May). Guidelines for secondary use of personal health information. https://www.jami.jp/wp-content/uploads/2021/07/amed2_report.pdf