AMIA Supports Efforts to Modernize Federal Research Protections

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AMIA Submits Comments to the U.S. Department of Health and Human Services' Office for Human Research Protections Supporting Proposals to Modernize the Common Rule.

In comments submitted to the U.S. Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP), the nation’s leading data scientists in healthcare supported several major proposals to modernize the Federal Policy for the Protection of Human Subjects, known as the Common Rule, especially those updates meant to facilitate rapid-cycle, large-scale learning within the healthcare enterprise. Officials from the American Medical Informatics Association (AMIA) said exclusions and exemptions to the Common Rule for secondary use, or “supplemental use,” of biospecimens and patient data are necessary to develop a learning health system.

OHRP issued a notice of proposed rulemaking in October asking for stakeholder input on how best to update the decades-old Common Rule by creating new exclusions and exemptions to the Common Rule; updating how informed consent should be obtained; revising certain institutional review board reviews and operations; define new rules pertaining to research with biospecimens and secondary research use of data. In comments, AMIA said the government’s proposals would address long-standing challenges of conducting research using modern technologies and techniques, while creating new challenges.

“We are entering a new age in healthcare what we can learn from tissues and data may be amplified when put into the broader context of a learning health system,” said AMIA Board Chair and Medical Director of IT Services at the University of Washington’s UW Medicine, Thomas H. Payne. “While privacy and security are paramount, it will be through the supplemental use of such tissues and data that true innovations and discovery can be made.”

However, the group warned that these much-needed updates would be costly and complex to implement.

“Despite our support for these new policies, we note that this approach, to create categorical exemptions and exclusions, is incredibly complex,” AMIA said in comments. “OHRP will need to engage in substantive efforts to clarify how this framework should be applied by stakeholders via use case examples, FAQs, and sub-regulatory guidance. We foresee the great likelihood of inconsistent implementation and varied interpretation among stakeholders, similar to our collective experience with HIPAA.”

From a technology standpoint, AMIA said the effort to implement the systems and controls necessary to comply with these revisions will be extensive. The group called on HHS to dedicate and coordinate resources, such as grant funding and contracts, meant to develop a technical infrastructure and shared resources that will enable compliance in this new paradigm.

AMIA officials also urged regulators to ensure exclusions and exemptions fall within the appropriate boundaries, supported by protocols to justify such determinations. Specifically, the group said use of the self-determination exemption tool should include some oversight mechanism to guard against conflicts of interest.

“Tectonic shifts in healthcare delivery and advancements in research are leading towards the development of a learning health system where science, informatics, incentives, and culture are aligned for continuous improvement and innovation, said AMIA President and CEO, Douglas B. Fridsma, MD, PhD. “If federal regulators work closely with private sector partners on implementation, and with the informatics community in specific, I’m confident we’ll enable a learning health system that protects patients’ rights, respects patients’ autonomy and improves health and healthcare.”

Click here to read AMIA’s full comments.

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AMIA, the leading professional association for informatics professionals, is the center of action for 5,000 informatics professionals from more than 65 countries. As the voice of the nation’s top biomedical and health informatics professionals, AMIA and its members play a leading role in assessing the effect of health innovations on health policy, and advancing the field of informatics. AMIA actively supports five domains in informatics: translational bioinformatics, clinical research informatics, clinical informatics, consumer health informatics, and public health informatics.

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Krista Martin
American Medical Informatics Association
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American Medical Informatics Association
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