I was quoted in Heartland Institute’s Health Care News about “Project Nightingale,” Google and Ascension Health’s data sharing partnership. One key question is whether the companies have obtained patients’ informed consent and institutional review board (IRB) approval for what appears to be research directed toward obtaining generalizable knowledge – rather than patient care or quality assurance activities – and therefore requires IRB approval. “While I think that [generalized knowledge] applies here, it is more in the nature of applied commercial-product research than pure medical investigation,” said Klein. “In a sense, it is reflective of newer modes of service provision enabled by ‘big data’ capabilities with which our regulatory efforts may not have kept pace.” https://www.heartland.org/news-opinion/news/google-data-partnership-with-insurer-raises-patient-privacy-concerns