What are the most effective data privacy frameworks for healthcare?

1 HIPAA and HITECH

The Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH) are the main federal laws that regulate data privacy and security in the US healthcare sector. HIPAA establishes the standards for protecting the confidentiality, integrity, and availability of protected health information (PHI), which includes any information that can identify a patient or relate to their health condition or treatment. HITECH enhances HIPAA by providing incentives and penalties for adopting electronic health records (EHR) and ensuring their security. HIPAA and HITECH apply to covered entities, such as health plans, providers, and clearinghouses, and their business associates, such as vendors, consultants, and contractors.

2 GDPR and ePrivacy

The General Data Protection Regulation (GDPR) and the ePrivacy Directive are the main legal frameworks that govern data privacy and security in the European Union (EU). GDPR applies to any organization that collects, processes, or transfers personal data of individuals in the EU, regardless of their location or industry. Personal data includes any information that can identify a person, such as name, email, address, or health data. GDPR grants individuals several rights over their data, such as access, rectification, erasure, portability, and objection. GDPR also requires organizations to implement appropriate technical and organizational measures to protect data, obtain consent from data subjects, report breaches, and appoint data protection officers. The ePrivacy Directive complements GDPR by setting specific rules for electronic communications, such as cookies, email marketing, and online tracking.

3 ISO 27001 and ISO 27799

The International Organization for Standardization (ISO) develops and publishes voluntary standards for various domains, including information security and health informatics. ISO 27001 is the most widely recognized standard for information security management systems (ISMS), which provide a systematic approach to managing the risks and controls related to information assets. ISO 27799 is an extension of ISO 27001 that specifies additional requirements for ISMS in healthcare organizations, especially regarding the protection of health information. ISO 27001 and ISO 27799 are compatible with other data privacy frameworks, such as HIPAA, GDPR, and ePrivacy, and can help organizations demonstrate their compliance and best practices.

5 FAIR and CARE

The FAIR and CARE principles are two sets of guidelines that aim to improve the quality and usability of data, especially in the context of research and innovation. FAIR stands for Findable, Accessible, Interoperable, and Reusable, and describes the characteristics that data should have to be easily discovered, accessed, integrated, and reused by humans and machines. FAIR principles support the open science and data sharing movements, and can help researchers increase the impact and reproducibility of their work. CARE stands for Collective Benefit, Authority to Control, Responsibility, and Ethics, and describes the values and responsibilities that data stewards and users should uphold to respect the rights and interests of data contributors, especially from indigenous and marginalized communities. CARE principles emphasize the importance of data governance, consent, accountability, and equity, and can help researchers foster trust and collaboration with data sources.