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For example, sharing information about someone on the street with an obvious medical condition such as an amputation is not restricted by U.S. law. However, obtaining information about the amputation exclusively from a protected source, such as from an electronic medical record, would breach HIPAA regulations. Business Associates
Under HIPAA, HIPAA-covered health plans are now required to use standardized HIPAA electronic transactions. See, 42 USC § 1320d-2 and 45 CFR Part 162. Information about this can be found in the final rule for HIPAA electronic transaction standards (74 Fed. Reg. 3296, published in the Federal Register on January 16, 2009), and on the CMS website.
HIPAA provides a federal minimum standard for medical privacy, sets standards for uses and disclosures of protected health information (PHI), and provides civil and criminal penalties for violations. Prior to HIPAA, only certain groups of people were protected under medical laws such as individuals with HIV or those who received Medicare aid. [41]
Examples of these regulations include Sarbanes–Oxley Act, Basel I, Basel II, HIPAA, GDPR, cGMP, [7] and a number of data privacy regulations. To achieve compliance with these regulations, business processes and controls require formal management processes to govern the data subject to these regulations. [8]
The HITECH Act requires entities covered by the Health Insurance Portability and Accountability Act (HIPAA) to report data breaches, which affect 500 or more persons, to the United States Department of Health and Human Services (U.S. HHS), to the news media, and to the people affected by the data breaches. [23]
The International Organization for Standardization (ISO) and its ISO 37301:2021 (which deprecates ISO 19600:2014) standard is one of the primary international standards for how businesses handle regulatory compliance, providing a reminder of how compliance and risk should operate together, as "colleagues" sharing a common framework with some nuances to account for their differences.
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