Legal and regulatory barriers to developing evidence and communicating findings on treatments in real-world settings are interfering with the sharing of knowledge among providers, patients, and researchers.

That’s the message to federal lawmakers from Mary Grealy, president of the Healthcare Leadership Council which represents CEOs of healthcare organizations, during testimony on July 22 before the House Energy and Commerce Subcommittee on Health. Though opportunities exist to capture and analyze data in real-world delivery settings, they are being hindered. What is needed, say advocates, is the free flow of data, research, and results related to the benefits and risk profiles of drugs and devices to advance the discovery, development and delivery cycles.

Each year, Grealy told lawmakers, millions of patients and consumers in the U.S. interact with the healthcare system at large creating literally trillions of decisions, communications, interventions, consultations, treatments and therapies. This “constant, never-ending cascade” of real-time data “contains the secrets to entering the next era of high-quality healthcare and developing the 21st century cures. The key to capturing this potential lies in putting the policies and practices in place that will allow us to harness this data.”

Grealy noted that the federal government possesses the greatest volume of healthcare data and called for federal data policies that strengthen access to information, not block it. “By excluding certain organizations from access to federal health data, federal policy is also excluding the deep scientific and analytic expertise that can bring improvements to the entire healthcare spectrum.”

For instance, federal “data use agreement” restrictions keep many healthcare organizations from gaining access to data that would allow them to improve care and reduce costs. “These agreements should be revised to allow organizations to get pre-approval for real-time access to CMS data for appropriate uses,” she asserted. “The current practice of precluding some organizations from purchasing data at all and substantial lag time in the availability of key information slows progress that could benefit everyone.”

Grealy also advocated that federal health data should no longer be denied to entities perceived to have a commercial interest. “Healthcare organizations are using advanced data analytics to improve healthcare quality, better manage population health and address consumer health needs using private-sector patient-level data,” she told the subcommittee. “These organizations can enhance their work with appropriate access to federal program data. Commercial entities could easily be held to the same Data Use Agreement standards as noncommercial entities.”

On the issue of private entity access to federally-held health data, Grealy applauded CMS in its proposed rule affecting the Medicare Part D and Medicare Advantage programs, for opening up the topic of access to Prescription Drug Event data by entities with commercial interests. “We recommend expanding the discussion to include the long-standing HHS policy that denies access by commercial entities to data from the Medicare Part A, B, C and Medicaid programs as well as other program datasets,” she said. “Profit status of the organization in question should not take precedence over the larger question of whether the research in which the organization is engaging is of high quality and has the potential to improve population health.”

Grealy also suggested policymakers adjust the authorization components of HIPAA as necessary to ensure that data can be used effectively in research settings. “We must be cognizant of the limitations HIPAA imposes on research into new cures and technologies. HIPAA was created at a time when policymakers were not thinking about the knowledge that could be gained by accessing data residing in large databases,” she testified. “We now are in an era where researchers can harness vast amounts of data to learn at a rapid pace unlike we have ever seen.”

Part of the problem, according to Grealy, is that in most research environments patient data must be de-identified before it can be utilized. While the Healthcare Leadership Council generally promotes the HIPAA de-identification standard to protect patient and consumer health data, she argued that policymakers must take into consideration that de-identified data is “not sufficiently useful to achieve particular research objectives.”

Another major obstacle to information sharing, Grealy said, are the 50 separate sets of state privacy laws and regulations that slow down medical and scientific progress. “It makes little sense and does not serve the public interest for healthcare entities and research to try to untangle inconsistent, overlapping laws,” she told the subcommittee. “In today’s world, information must be transmitted across state lines and laws should enable this data sharing, not obstruct it.”

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