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However, data-intensive, decentralised clinical trials also present a major risk to healthcare participants through cybercrime and data privacy vulnerability. HIPAA in the United States, a regulatory reference, was designed to protect patient privacy but not necessarily data security.
Because the regulatory oversight of COVID became highly politicized, and after some missteps by FDA, some states have indicated that any federal decision will be reviewed, but that does not seem likely to present much a barrier in terms of timeline, if at all. But first there will be regulatory rites of passage.
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