Healthcare Compliance Series #9
The digital age has brought about significant advancements in healthcare, enabling the seamless exchange and management of health data. However, this progress has also raised concerns about the privacy and security of sensitive health information. To address these concerns, various countries have implemented laws and regulations to govern the handling of health data, ensuring that individuals’ personal information remains confidential and secure. This article will provide an overview of some of the most significant international healthcare-focused regulations, their objectives, and penalties associated with non-compliance.
HIPAA (Health Insurance Portability and Accountability Act) (USA)
- Date of inception: August 21, 1996
HIPAA is a federal law in the United States that sets national standards for protecting the privacy and security of individuals’ medical records and personal health information. It regulates the use and disclosure of Protected Health Information (PHI) and electronic PHI (ePHI) by healthcare providers, health plans, and healthcare clearinghouses. HIPAA aims to ensure that personal health information remains confidential and secure, while also enabling healthcare providers to share information necessary for treatment, payment, and healthcare operations.
Penalties: Fines up to $50,000 per violation, with an annual maximum of $1.5 million
The Data Protection Act (DPA) UK
- Date of inception: March 24, 2018 (replacing the previous Data Protection Act 1998)
The Data Protection Act (DPA) is a UK law that regulates the processing of data, including health data. It supplements the General Data Protection Regulation (GDPR) in the UK and aims to protect individuals’ privacy rights while enabling lawful and fair data usage for medical research and public health operations. The DPA sets out principles for data processing, including data minimization, accuracy, and security, and grants individuals rights to access, rectify, and erase their personal data.
Penalties: Fines up to £17.5 million or 4% of annual global turnover, whichever is greater.
GDPR (General Data Protection Regulation) (EU)
- Date of inception: May 25, 2018
The GDPR is a comprehensive data protection law in the European Union that imposes strict requirements on the processing of personal data within the EU and for organizations outside the EU that handle the data of EU residents. The GDPR includes specific provisions regarding health data, and it sets out principles for data processing, including consent, data minimization, and security. The regulation also grants individuals rights to access, rectify, and erase their personal data.
Penalties: Fines up to €20 million or 4% of a company’s global annual turnover, whichever is greater.
The My Health Records Act (Australia)
- Date of inception: October 2012
The My Health Records Act is an Australian law that governs the creation and management of electronic health records. It aims to ensure the privacy, security, and access controls for individuals’ health information nationwide. The Act sets out rules for the collection, storage, and sharing of health data, and it grants individuals the right to access and control their health information.
Penalties: Fines up to $200,000 for individuals and $500,000 for organizations
Digital Data Protection Act (DPDP-23) India
- Date of inception: August 11, 2023
The Digital Data Protection Act (DPDP-23) is an Indian law that aims to safeguard digital data, including health information, by setting standards for its collection, processing, storage, and sharing. The Act sets out principles for data processing, including consent, data minimization, and security, and it grants individuals rights to access, rectify, and erase their personal data.
Penalties: Fines for individuals up to ₹10,000; for entities up to ₹250 crores (approximately $3 million) depending on the severity of the breach.
The LGPD Brazil
- Date of inception: August 14, 2018
The LGPD is a Brazilian law that regulates the handling of personal data, including health data. It sets out principles for data processing, including consent, data minimization, and security, and it grants individuals rights to access, rectify, and erase their personal data. The LGPD aims to ensure the privacy and security of individuals’ personal and health data.
Penalties: Fines up to 4% of a company’s Brazilian revenue, with a maximum of R$50 million (approximately $13 million USD)
The Protection of Personal Information Act (POPIA) in South Africa
- Date of inception: July 1, 2020
POPIA is a South African law that includes provisions regarding the protection of health data. It sets out principles for data processing, including consent, data minimization, and security, and it grants individuals rights to access, rectify, and erase their personal data. POPIA aims to ensure adherence to strict privacy and security standards, safeguarding the confidentiality and integrity of personal health data.
Penalties: Fines up to R10 million (approximately $670,000 USD)
Protection of Personal information Act (APPI) Japan
- Date of inception: September 2003
The APPI is a Japanese law that regulates the handling of personal health information. It sets out principles for data processing, including consent, data minimization, and security, and it grants individuals rights to access, rectify, and erase their personal data. The APPI aims to ensure the privacy and security of individuals’ personal and health data.
Penalties: Fines up to ¥500,000 (approximately $4,500 USD)
DSL (Data Security Law) China
- Date of inception: May 1, 2018
The Data Security Law is a Chinese law that regulates the handling of data, ensuring the security and confidentiality of individuals’ personal and health data. It sets out principles for data processing, including data minimization, security, and privacy by design, and it grants individuals rights to access, rectify, and erase their personal data.
Penalties: Fines up to RMB 10 million (approximately $1,560,000 USD):
PHIPA (Personal Health Information Protection Act) (Canada)
- Date of inception: November 1, 2004 (Ontario, Canada)
PHIPA is a provincial law in Ontario, Canada, that aims to safeguard the privacy, confidentiality, and security of individuals’ personal health information within the healthcare sector. It sets out principles for data processing, including consent, data minimization, and security, and it grants individuals rights to access, rectify, and erase their personal health information.
Penalties: Fines up to $100,000 per violation, with a maximum of $500,000 in a single year
Conclusion
International healthcare-focused regulations are essential to ensure the privacy and security of individuals’ personal and health data. The regulations outlined in this article demonstrate the commitment of various countries to protecting sensitive information and upholding individuals’ rights. It is crucial for healthcare providers, organizations, and individuals to understand and comply with these regulations to avoid penalties and maintain public trust. By working together, we can ensure that personal health information remains confidential and secure while enabling necessary data sharing for medical research and public health operations.
Stay tuned for next topic: Electronic Health Records (HER) Compliance (Healthcare Compliance Series #10)