• The least consequential part of 21st Century Cures?

    One provision of the new law pertains to a proposed rule from SAMHSA that would, among other things, restore researchers’ access to data on substance use disorders.

    Sec. 11002. Confidentiality of records. Not later than 1 year after the date on which the Secretary of Health and Human Services (in this title referred to as the ‘‘Secretary’’) first finalizes regulations updating part 2 of title 42, Code of Federal Regulations, relating to confidentiality of alcohol and drug abuse patient records, after the date of enactment of this Act, the Secretary shall convene relevant stakeholders to determine the effect of such regulations on patient care, health outcomes, and patient privacy.

    In plain English, this is just an instruction to hold a stakeholder conference once the rule is finalized. It doesn’t require SAMHSA to finalize the rule. And even if the rule is finalized, the agency isn’t obliged to adopt the portions governing research access. Austin and I would’ve preferred a genuine legislative fix, not this vague commitment to hold a meeting.

    The provision does, however, reflect Congress’s expectation that something along the lines of the proposed rule will eventually be adopted, even in a Trump administration. Given the regulatory moratorium that President Trump is likely to impose on any new rulemaking, that counts as mildly encouraging news.

    @nicholas_bagley

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