Fixing the privacy rules for researchers

For those of you who haven’t been following the story, the federal government recently began redacting substance use data from key Medicare and Medicaid files that they share with researchers. Although the Substance Abuse and Mental Health Services Administration (SAMHSA) hadn’t noticed for decades, privacy regulations codified in 42 C.F.R. Part 2 appear to prohibit CMS from sharing such data for research purposes. (Check out our extensive coverage here.)

The same regulations also create serious problems for providers. As Austin explained at the New York Times, “doctors’ offices and hospitals are not allowed to share patient data pertaining to substance-use disorders or treatment without each patient’s consent to each transmission of information.” That complicates efforts to coordinate care for patients who struggle with addiction.

When it comes to providers, there’s some interest in revising the rules to enable information-sharing. SAMHSA, for example, told OMB that it planned to propose a rule in the spring of 2015 (we’re still waiting!) to “facilitate the inclusion of clinical information” relating to substance use disorders in electronic medical records. And Representatives Tim Murphy and Paul Tonko have been pushing legislation, known as the 21st Century Cures Act, that would loosen the limits on sharing clinical data among providers.

These are helpful efforts—for providers. They don’t do anything for researchers.

Now, the 21st Century Cures Act could always be amended to include a fix for researchers. It’s also possible that SAMHSA will push for a research-related fix, either in a separate rulemaking or as part of a broader effort to revise 42 C.F.R. Part 2. Indeed, a recent statement from SAMHSA’s head says that such a fix is in the works.

But both Congress and the agency appear to be focused on problems relating to providers. They have only recently awoken to researchers’ concerns. Without organized, persistent pressure from the research community, I fear that those concerns will be all too easily overlooked.


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