Risk-based regulatory framework for health IT




September 4, 2013 the Health IT Policy Committee (HITPC) accepted and approved recommendations from the Food and Drug Administration Safety and Innovation Act (FDASIA) working group for a risk-based regulatory framework for health information technology. The Food and Drug Administration (FDA), the Office of the National Coordinator for Health IT (ONC), and Federal Communications Commission (FCC) kicked off the FDASIA workgroup of the HITPC to provide stakeholder input into a report on a risk-based regulatory framework that promotes safety and innovation and reduces regulatory duplication, consistent with section 618 of FDASIA. This provision permitted the Secretary of Health and Human Services (HHS) to form a workgroup in order to obtain broad stakeholder input from across the health care, IT, patients and innovation spectrum. The FDA, ONC, and FCC actively participated in these discussions with stakeholders from across the health care, IT, patients and innovation spectrum.

HIMSS Good Informatics Practices-GIP is aligned with FDA risk-based regulatory framework for health information technology. GIP development began in 2004 developing risk-based IT technical guidance. Today the GIP peer-review and published modules are widely used as a tool for educating Health IT professionals.

Interoperable HIT will improve individual patient care, but it will also bring many public health benefits including:

  • early detection of infectious disease outbreaks around the country;
  • improved tracking of chronic disease management;
  • evaluation of health care based on value enabled by the collection of de-identified price and quality information that can be compared

According to an article published in the International Journal of Medical Informatics, health information sharing between patients and providers helps to improve diagnosis, promotes self care, and patients also know more information about their health. The use of electronic medical records (EMRs) is still scarce now but is increasing in Canada, American and British primary care. Healthcare information in EMRs are important sources for clinical, research, and policy questions. Health information privacy (HIP) and security has been a big concern for patients and providers. Studies in Europe evaluating electronic health information poses a threat to electronic medical records and exchange of personal information. Moreover, software's traceability features allow the hospitals to collect detailed information about the preparations dispensed, creating a database of every treatment that can be used for research purposes.

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