- The American Medical Informatics Association (AMIA) recently submitted a letter to HHS Secretary Tom Price, MD requesting the implementation of the updated Federal Policy for the Protection of Human Subjects (Common Rule) to keep pace with rapid EHR adoption.
In the letter, AMIA pushed for the updated rule to go into effect on January 19 of next year. The association also requested HHS let stakeholders know about plans to implement the updated revision of the Common Rule. Lastly, AMIA recommended HHS set the rule’s compliance date for June 19, 2018 so the industry has time to align with both old and new provisions.
“Numerous stakeholders, including patients, researchers, manufacturers, healthcare providers, and the government itself, acknowledged in the final rule that substantial updates were needed to keep pace with innovation,” stated the organization.
AMIA stated the 21 Century Cures Act of 2016 necessitates that HHS update and implement the Common Rule in an effort to deliver better cures to patients faster.
The association also cited MACRA implementation as a catalyst for the dramatic shift in focus for clinical stakeholders toward critical analyses of quality, cost, and outcomes due to value-based payment models.
“To be successful under MACRA, providers will need to leverage clinical data and align research efforts to improve patient-centered care,” said AMIA. “Various provisions in the updated Common Rule provide for better access to EHR data for such purposes and lower administrative barriers to conduct more meaningful research in hospitals and physician offices.”
A growing interest in pursuing and improving population health management also prompted the organization to seek swift implementation of modifications to the Common Rule.
“The merging of research and care through large-scale human genome sequencing and proteomics projects has also provided new insights into population health, disease management and cures,” stated the association. “AMIA firmly believes the revised Common Rule will result in quicker translation of these discoveries into patient-centered care.”
The rapid adoption of EHR technology, the introduction of value-based payment models, and the development of learning health systems together contribute to a pressing need for Common Rule updates to go into effect, said the association.
The final rule in particular enacts the following provisions to improve the availability of health data for research while protecting research participants:
- Makes important changes to consent by requiring the most important information regarding a study to be explained clearly and concisely, and in a way that a “reasonable person” could understand;
- Permits researchers to seek broad consent, which will greatly improve the availability of biospecimens and patient-reported data (including real-time data from mobile applications and devices) for secondary research;
- Enables more secondary research of EHR data by exempting certain low-risk studies conducted by HIPAA covered entities.
- Such research could include observational studies meant to find patterns in patient records to improve how joint replacements are performed.
- Clarifies that certain public health surveillance activities are explicitly outside the scope of the Common Rule, so that the spread of disease can be more easily monitored.
- Eliminates the need for continuing review for many studies, reducing administrative burden.
- Provides a new option meant to help screening of potential participants, so patients who qualify for new treatments are more likely to learn about them.
These most recent revisions to the Common Rule represent transparency and constructiveness in government regulation.
The process of revising the Common Rule began over five years ago.
AMIA encourages the federal agency to see these changes through to improve clinical research.