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HIPAA, or the Health Insurance Portability and Accountability Act, is a United States Federal Law designed to protect the privacy and security of Protected Health Information (PHI) for US citizens.
The standard sets a national framework for safeguarding the medical information of individuals, meaning any service providers, digital health or med-tech products, processing identifiable data must comply.
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HIPAA is made up of 4 key rules, with these applying to ‘Covered Entities’ or Healthcare providers who control Personal Health Information (PHI) and ‘Business Associates’ who perform certain functions or activities that involve the processing or disclosure of PHI on behalf of a covered entity.
This sets the national standard for the protection of Personal Health Information, limiting its use without patient authorisation.
This rule sets the standard for the management of electronic-PHI and focuses on the measures which need to be implemented, whether administrative, physical or technical, to protect e-PHI.
The rule requires entities to notify individuals affected by breaches in the control or processing of PHI, the Department of Health and Human Services and sometimes the media, depending on the scale and impact of the breach. Similar to the Information Commissioner's Office (ICO) in the UK, there is also an expected timeline for when breaches should be reported.
This outlines the penalties for organisations who breach the Privacy or Security Rules or fail to comply with the standard
Individuals
HIPAA grants rights to individuals over their healthcare data, ensuring it is stored and processed legally and confidentially.
Healthcare Providers
They have a legal obligation to safeguard patient data and HIPAA is established as the Federal precedent for all healthcare providers.
Health Plans & Insurance
Health Plans and Insurance must safeguard their members data as part of the Federal mandate and only share it when appropriate to do so.
Business Associates
Any organization that works with covered entities and has access to protected health information (PHI), must comply with HIPAA.
Government Agencies
The Department of Health and Human Services is responsible for enforcing HIPAA regulations and imposing fines on organisations that breach the rules.
HIPAA provides assurances to your customers of your commitment to information security, illustrating your organisation as a credible and trusted partner.
Committing to International expansion is no small decision, so we’ve collated a number of resources to help you. Access our free Blogs or get in touch to learn more about HIPAA and the requirements for a successful US market entry.
HIPAA, the Health Insurance Portability and Accountability Act of 1996, is a U.S. federal law designed to protect the privacy and security of individuals' health information, known as Protected Health Information (PHI). Key components include the Privacy Rule, which sets guidelines for PHI use; the Security Rule, which focuses on protecting electronic PHI (ePHI); and the Breach Notification Rule, which requires reporting of data breaches.
Yes, if your business involves handling Protected Health Information (PHI) within the U.S. healthcare system, you are likely required to comply with HIPAA. This requirement extends across both the public and private healthcare systems within the US as it is a Federal Law.
Much like the NHS Data Security Protection Toolkit (DSPT), HIPAA is a mandatory self-assessment without a formal certification pathway. This means the business must implement the recommended controls within their organisation to claim compliance. If you’re struggling with HIPAA and need help to implement a compliant system and process, get in touch - we’d be happy to help.
We expect most companies starting from scratch to be HIPAA compliant within 12 weeks. However, this timeline can vary depending on the size of the organisation and the maturity of its information security and data protection documentation.
Whilst HIPAA focuses on protecting patient health information within the healthcare industry, SOC 2 is a broader framework for ensuring the security, availability, processing integrity, confidentiality, and privacy of data handled by service organizations, regardless of industry. HIPAA and SOC 2 are often requested together for organisations that process extensive PHI and both requirements can be integrated into one information security management system.
Yes. There are many similarities between the requirements. Get in touch to learn more.
Speak to a Member of our Expert Team about how you can adopt HIPAA as part of your compliance portfolio
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