A new partnership between the National Institutes of Health (NIH) and the Centers for Medicare & Medicaid Services (CMS) will make possible a “real-world data platform enabling advanced research across claims data, electronic medical records, and consumer wearables,” the Department of Health & Human Services (HHS) said in a May 7 press release.
“We’re using this partnership to uncover the root causes of autism and other chronic diseases,” HHS Secretary Robert F. Kennedy Jr. said in the press release. “We’re pulling back the curtain — with full transparency and accountability — to deliver the honest answers families have waited far too long to hear.”
Per the Trump administration’s “Make America Healthy Again” mandate, CMS Administrator Mehmet Oz, M.D. said his goals upon starting in his new position included “Shifting the paradigm for health care from a system that focuses on sick care to one that fosters prevention, wellness and chronic disease management.”
Patients with chronic conditions such as chronic obstructive pulmonary disease (COPD), congestive heart failure, diabetes, and sleep apnea could potentially benefit from improved funding and education, as well as a proactive treatment stance — if HHS goes in that direction.
Autism will be the first focus of the NIH-CMS partnership.
Concerns over being added to a national ‘registry’
“CMS and NIH will start this partnership by establishing a data use agreement under CMS’s Research Data Disclosure Program focused on Medicare and Medicaid enrollees with a diagnosis of ASD [autism spectrum disorder],” the release announced. The ASD pilot program “will inform continued development of a landmark NIH platform to ultimately be used by researchers in understanding health-care utilization, chronic disease etiology and treatment, and the economic burden of chronic conditions.”
Despite the press release’s contention that researchers would handle patient data “in a manner consistent with applicable privacy laws,” some stakeholders voiced concern, in part because reports that surfaced in April said HHS planned to build a nationwide registry of people with autism.
On April 24, HHS said it does not plan to create an autism registry. That did not entirely ease the concerns of the Autistic Self Advocacy Network (ASAN), as an example. Also on April 24, ASAN said in a statement, “At present, it is unclear what data will be included in the announced autism database — what the sources of the data will be, how they will be connected, and, crucially, whether any Personally Identifiable Information (PII) about autistic people will be provided to researchers. If all PII is actually stripped out of the database, and individuals cannot be identified, then it is normal practice to distribute that information to researchers without individuals’ specific consent.”
Privacy, the ASAN statement continued, “would likely not be endangered by deidentified data being shared with researchers. Except when we feel the research is harmful for other reasons, ASAN supports the use of large federal health-care datasets for research purposes, including ones that link information from multiple sources, provided that that data is thoroughly and carefully deidentified. On the other hand, if individuals are identifiable based on the provided information, then serious concerns about privacy are very much warranted.”
Acorn Health, a provider of applied behavior analysis therapy for children diagnosed with ASD, has reported to Behavioral Health Business that a number of parents canceling assessment and diagnostic appointments for their children out of concerns for their privacy following talk about the government creating a federal autism registry.
