Abstract
This chapter covers the significant federal regulations that impact the imaging informatics professional, as well as current federal efforts to promote interoperability. This chapter ends with a review of the requirements for professional certification in imaging informatics.
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Further Readings
American Board of Imaging Informatics. About ABII. https://www.abii.org/About.aspx. Last accessed 10/10/2020.
Carequality. Imaging data exchange implementation guide, version 0.2. https://carequality.org/wp-content/uploads/2019/11/Imaging-Data-Exchange-Implementation-Guide-v02.pdf. Last accessed 10/10/2020.
Federal Register. CMS interoperability and patient access for Medicare Advantage Organization and Medicaid Managed Care Plans State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, issuers of qualified health plans on the federally-facilitated exchanges, and the health care providers. 1 May 2020. https://www.federalregister.gov/documents/2020/05/01/2020-05050/medicare-and-medicaid-programs-patient-protection-and-affordable-care-act-interoperabilityand. Last accessed 10/10/2020.
Federal Register. HIPAA Omnibus final rule. 25 Jan 2013. https://www.govinfo.gov/content/pkg/FR-2013-01-25/pdf/2013-01073.pdf. Last accessed 10/9/2020.
Food & Drug Administration. How to determine if your product is a medical device. https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device#introduction. Last accessed 10/10/2020.
Food & Drug Administration. Mammography Quality Standards Act (MQSA). https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mammography-quality-standards-act-mqsa. Last accessed 10/10/2020.
Food & Drug Administration. Digital breast tomosynthesis (DBT) system. https://www.fda.gov/radiation-emitting-products/facility-certification-and-inspection-mqsa/digital-breast-tomosynthesis-dbt-system. Last accessed 10/10/2020.
Food & Drug Administration. Regulations to Conform Medical Software Provisions in the 21st Century Cures Act. https://public-inspection.federalregister.gov/2021-07860.pdf. Last accessed 5/28/2021.
The Office of the National Coordinator for Health Information Technology. Connecting health and care for the nation: a shared nationwide interoperability roadmap. https://www.healthit.gov/sites/default/files/hie-interoperability/nationwide-interoperability-roadmap-final-version-1.0.pdf. Last accessed 10/9/2020.
The Office of the National Coordinator for Health Information Technology. Trusted exchange framework and common agreement (TEFCA) draft 2. https://www.healthit.gov/sites/default/files/page/2019-04/FINALTEFCAQTF41719508version.pdf. Last accessed 10/10/2020.
The Office of the National Coordinator for Health Information Technology. 21st Century Cures Act: interoperability, information blocking, and the ONC health IT certification program. https://www.healthit.gov/sites/default/files/cures/2020-03/ONC_Cures_Act_Final_Rule_03092020.pdf. Last accessed 10/10/2020.
U.S. Department of Health & Human Services. HIPAA for professionals. https://www.hhs.gov/hipaa/for-professionals/index.html. Last accessed 10/9/2020.
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Brown, D.E. (2021). Policy Management and Regulatory Compliance. In: Branstetter IV, B.F. (eds) Practical Imaging Informatics. Springer, New York, NY. https://doi.org/10.1007/978-1-0716-1756-4_30
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DOI: https://doi.org/10.1007/978-1-0716-1756-4_30
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