Healthcare Regulatory Bodies

Department of Commerce

NIST – National Institute of Standards and Technology

  • Coordinates standards
  • Coordinates infrastructure testing
  • Improve EHR usability
  • Extend healthcare’s reach through technology
  • R&D

Defines requirements of SLAs, but does NOT involve financial penalties for failure

Malcolm Baldrige National Quality Award

HITECH Act

NIST, ONC and HITSP (Healthcare Information Technology Standards Panel, a public/private partnership) create ISO standards for interoperability.

Department of Health and Human Services (HHS)

“Responsible for protecting the health of all Americans.”

12 Operating Divisions, including CMS

Center for Medicare and Medicaid Services (CMS)

CMS runs Medicare for people over 65

Part A – Inpatient care

Part B – Outpatient care

Prescription Drug Coverage

Heavily involved in HIPAA implementation

Their standards are often adopted across the medical industry.

17 Staff Divisions

ONC – Office of the National Coordinator for Health Information Technology

“The Office of the National Coordinator for Health Information Technology (ONC) is at the forefront of the administration’s health IT efforts and is a resource to the entire health system to support the adoption of health information technology and the promotion of nationwide health information exchange to improve health care. ONC is organizationally located within the Office of the Secretary for the U.S. Department of Health and Human Services (HHS).” http://www.healthit.gov/newsroom/about-onc

ONC certifies EHR systems

  • Standards and certification criteria for EHS
  • Certification programs
  • Metadata definitions

National Committee on Vital and Health Statistics

Governing body that sets standards for the transmission of PHI.

FDA

The agency that certified Xrays for use on humans.

Title 21 CFR

Part 21: Individual records maintained, used and disclosed by the FDA

Part 7: Recalls of drugs, food or cosmetics

Part 11: Electronic records and digital signatures defined

Digital signatures are used for:

  • Medicare certifications
  • Remote site patient records,
  • Referrals
  • Computerized Physician Order Entry

ASTM – American Society for Testing and Materials

E1384 – Components and contents of patient records; definitions of nomenclature

Basically this involves ensuring records contain required information.

NCQA – National Committee for Quality Assurance

A U.S. independent nonprofit accrediting body for managed health care organizations

Uses HEDIS, Healthplan Employer Data and Information Set, to measure and publish info about managed care plans for employers and consumers.

The Joint Commission for the Accreditation of Healthcare Organizations

Monitors the safety and effectiveness of treatments provided by healthcare providers.

Requires a review of all delinquent medical records at least once every 90 days.

Requires dictation and transcription of acute history and physicals within 24 hours.

Requires that history and physical of chronic care patients be dictated and transcribed within 30 days.

Requires that a patient’s medical record be completed within 30 days (for instance, after discharge).

DICOM

Digital Images and Communication in Medicine

Dictates standards for handling, storing, printing and transmitting medical images.

HL7 (Health Level 7)

International community of healthcare SMEs and info scientists.

Promotes informatics standards to improve healthcare info delivery.

Creates standards for exchange, management and integration of EHI.

Dictates data field types and contents.

Provider Type specifies the major grouping of the service or occupation of the practitioner.

Other bodies

OSHA dictates safety for all workers.