The HIT Policy Committee has issued recommendations to ease secondary uses of electronic health records data.
In particular, use of EHR data for treatment purposes or to evaluate the safety, quality and effectiveness of prevention and treatment activities should not require patient consent, institutional review board approval or even minimal registration, according to the federal advisory body.
The committee believes the Department of Health and Human Services "could take the approach of not labeling these activities as 'research' but instead should consider them to be treatment or operations if conducted by, or on behalf of (such as by a business associate), a provider entity." Providers, however, should always use the minimum necessary amount to accomplish the task.
The policy committee recommendations follow HHS issuance in July of an advanced notice of proposed rulemaking to update the federal Common Rule governing the protection of human research subjects, including their information. Under the proposed rulemaking, the government seeks comment in a number of areas, including the privacy and security of research information.
Types of activities the committee believes could be covered using EHR include, among others, data to improve patient care such as evaluating effectiveness, identification of patterns of adverse events, evaluation of interventions to improve quality such as reduced infection rates, monitoring performance of individual clinicians and professional staff, and outreach efforts to increase patient compliance.
The HIT Policy Committee comments on the advanced notice of proposed rulemaking are available here under Draft Transmittal Letter.
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