In an American Health Law Association Health Law Weekly article, health care partner David Peloquin, counsel Leslie Thornton and associate Carolyn Lye examined the National Institutes of Health Office of Science Policy’s resource document (the “Resource”) on key considerations and sample language for informed consent for research using digital health technologies.
The Resource aims to assist researchers in developing materials that promote potential study participants’ understanding of the unique data privacy and security risks created by digital health technologies such as tablets, wearables and smart phones.
The authors summarize certain key considerations outlined in the Resource, discuss implications for key stakeholders, including research institutions, researchers and funders, and discuss other evolving laws and regulations that may be implicated by the use of digital health technologies in studies.
The authors note that while fairly comprehensive, the Resource’s key considerations and sample language do not address certain other obligations that investigators may need to consider as part of the informed consent process. Nor do they address other recent legal developments in the area, such as subregulatory guidance and enforcement actions related to online tracking technologies or data sharing requirements under the Information Blocking Rule. The authors address the implications that each of these other recent legal developments may have for researchers and their institutions as well as research sponsors and funders.
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