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Health Information Technology Laws

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GDPR and Health Data

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The General Data Protection Regulation is an EU regulation that impacts how health data of EU citizens must be handled, including obtaining explicit consent to process health data and providing robust protections against unauthorized access and breaches.

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Meaningful Use

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A set of criteria that governs the use of electronic health records and allows eligible providers and hospitals to earn incentive payments by meeting specific criteria. It ensures the protection of private patient information when using EHRs.

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ePHI

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Electronic Protected Health Information is any protected health information that is created, stored, transmitted, or received electronically. Security measures must be applied to ensure its confidentiality, integrity, and availability.

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MACRA

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The Medicare Access and CHIP Reauthorization Act changes the reimbursement of health care providers for those with Medicare by incentivizing quality care. It includes provisions for maintaining the security and privacy of patients' health information.

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ONC HIT Certification Program

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Established by the Office of the National Coordinator for Health Information Technology to provide a voluntary certification to EHR and other health IT. Compliance ensures that the software meets the standards for information exchange and patient privacy/security.

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HL7

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Health Level Seven International, a set of international standards for the transfer of clinical and administrative data between software applications used by various healthcare providers.

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ONC's Interoperability Framework

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The Office of the National Coordinator for Health IT promotes a set of standards, specifications, and practices for health IT that facilitates access, exchange, and use of electronic health information, while ensuring security and privacy.

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Clinical Decision Support (CDS)

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Tools and systems that help healthcare professionals make clinical decisions by analyzing data from various sources and presenting them in an accessible way, raising questions of data governance and privacy.

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PCI DSS

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The Payment Card Industry Data Security Standard governs how credit card information is handled and protected in any environment, including healthcare, to reduce credit card fraud.

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FDA regulations on medical devices

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The U.S. Food and Drug Administration (FDA) ensures that medical devices, including health IT software, meet certain safety and efficacy standards, with implications for the privacy and security of health data processed by these devices.

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HIPAA

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The Health Insurance Portability and Accountability Act sets the standard for protecting sensitive patient data. Any company that deals with PHI must ensure that all the required physical, network, and process security measures are in place and followed.

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Telehealth regulations

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Federal and state laws that establish the standards for the delivery of healthcare services through telecommunication technology, setting frameworks for protecting patients' privacy and securing the electronic exchange of health information.

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Breach Notification Rule

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Under the HITECH Act and HIPAA, organizations must provide notification following a breach of unsecured PHI. This includes individual notification, media notification, and a notice to the Secretary of HHS.

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HIPAA Privacy Rule

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Establishes national standards to protect individuals' medical records and other personal health information. It requires appropriate safeguards to protect privacy of personal health information.

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42 CFR Part 2

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A federal law that regulates the sharing of substance use disorder treatment records. It establishes protective measures for patient records created by federally assisted programs.

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HITECH Act

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The Health Information Technology for Economic and Clinical Health Act promotes the adoption and meaningful use of health information technology. It specifically addresses the privacy and security concerns associated with the electronic transmission of health information.

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FHIR

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Fast Healthcare Interoperability Resources, an HL7 standard for electronic exchange of healthcare information. FHIR aims to simplify implementation without sacrificing information integrity and ensures privacy and security in the process.

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CCHIT

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The Certification Commission for Health Information Technology was an independent, not-for-profit group that certified electronic health records and other health information technology products for compliance with specific criteria to ensure they met federal standards for security and privacy.

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HIPAA Security Rule

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Specifies a series of administrative, physical, and technical safeguards for covered entities to use to assure the confidentiality, integrity, and availability of ePHI.

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EHR Incentive Programs

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Incentive programs guided by the Centers for Medicare & Medicaid Services (CMS) that provide financial incentives for the meaningful use of certified EHR technology to improve patient care, including secure data exchange and patient privacy.

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