Skip to content
8foldgovernance master
  • Services
    • AI Governance
    • Medical Devices
      • Regulatory Roadmap
      • ISO 13485 Design & Build your QMS
      • Quality Management as a Service
      • Technical File Creation & Registration
      • UK Responsible Person
      • Post Market Surveillance
    • International Standards
      • ISO 13485 Certification
      • ISO 42001 Certification
      • ISO 9001 Certification
      • ISO 27001 Certification
    • DTAC
      • DTAC Management
    • Information Governance
      • Data Security & Protection (DSPT)
      • DSPT Audit
      • HIPAA Compliance
    • Clinical Safety and Risk Management
      • DCB0129
      • DCB0160
      • Clinical Safety Officers (CSO)
    • CQC Services
      • CQC Compliance Assessment
      • CQC Registration Support
      • CQC-as-a-Service
      • CQC Regulatory Review & Strategy
    • Cyber Security
    • Governance, Risk & Compliance Advisory
    • 8foldTraining
  • About
    • Meet the Team
    • Partnerships
    • Join Us
  • Blog
  • Case Studies
  • Contact
  • Services
    • AI Governance
    • Medical Devices
      • Regulatory Roadmap
      • ISO 13485 Design & Build your QMS
      • Quality Management as a Service
      • Technical File Creation & Registration
      • UK Responsible Person
      • Post Market Surveillance
    • International Standards
      • ISO 13485 Certification
      • ISO 42001 Certification
      • ISO 9001 Certification
      • ISO 27001 Certification
    • DTAC
      • DTAC Management
    • Information Governance
      • Data Security & Protection (DSPT)
      • DSPT Audit
      • HIPAA Compliance
    • Clinical Safety and Risk Management
      • DCB0129
      • DCB0160
      • Clinical Safety Officers (CSO)
    • CQC Services
      • CQC Compliance Assessment
      • CQC Registration Support
      • CQC-as-a-Service
      • CQC Regulatory Review & Strategy
    • Cyber Security
    • Governance, Risk & Compliance Advisory
    • 8foldTraining
  • About
    • Meet the Team
    • Partnerships
    • Join Us
  • Blog
  • Case Studies
  • Contact
  • +44 (0)1273 569172
Book a Call

HIPAA

Inspiring Trust in US Healthcare

HIPAA

Why work with 8fold on HIPAA?

  • Global Compliance Expertise – we have the knowledge and experience internally to help you address your compliance obligations
  • Integrated Policies and Procedures – we don’t believe in creating compliance silos; let us integrate HIPAA into your existing information security management system.
  • Reduced Compliance Burden  – allow us to take on the burden of HIPAA compliance while you focus on whats important; bringing impact to patients and your clients.
  • Trusted by Global MedTech and Digital Health businesses – trust us to ensure quality and provide global assurance.

Trust us to inspire confidence in Payors, Providers and Insurers. Collaborate with 8foldGovernance to address your HIPAA requirements.

Book a Call

Ensuring Privacy and Security

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.

Need help with HIPAA to enter the US Market?

Find out how our team of in-house experts can help you.

Learn More
8foldGovernance team — UK healthcare compliance experts
Health Insurance Portability and Accountability Act (HIPAA)

Key Aspects of HIPAA.

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.

The Privacy Rule

This sets the national standard for the protection of Personal Health Information, limiting its use without patient authorisation.

The Security Rule

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 Breach Notification Rule

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.

The Enforcement Rule

This outlines the penalties for organisations who breach the Privacy or Security Rules or fail to comply with the standard

Ready to Get Started?

Who cares about HIPAA?

Healthcare startups and SMEs — compliance support

Individuals

HIPAA grants rights to individuals over their healthcare data, ensuring it is stored and processed legally and confidentially.

Medical service providers — NHS digital health compliance

Healthcare Providers

They have a legal obligation to safeguard patient data and HIPAA is established as the Federal precedent for all healthcare providers.

HIPAA HIPAA compliance HIPAA,complying with hipaa,hipaa rules

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.

HIPAA HIPAA compliance HIPAA,complying with hipaa,hipaa rules

Business Associates

Any organization that works with covered entities and has access to protected health information (PHI), must comply with HIPAA.

Enterprise healthcare organisations — specialist compliance support

Government Agencies

The Department of Health and Human Services is responsible for enforcing HIPAA regulations and imposing fines on organisations that breach the rules.

Need Help complying with HIPAA? Get In Touch.
Book Your Free Discovery Call Today

Benefits of HIPAA.

HIPAA HIPAA compliance HIPAA,complying with hipaa,hipaa rules

Enhanced Data Security Practices

HIPAA’s Security Rule mandates the implementation of robust security measures to protect electronic protected health information (ePHI). Implementing HIPAA illustrates a commitment to safety and security.
HIPAA HIPAA compliance HIPAA,complying with hipaa,hipaa rules

Global Recognition

HIPAA is a globally recognised certification for the protection of protected health information, contributing to international data-sharing arrangements managed by Governments and regulators.
HIPAA HIPAA compliance HIPAA,complying with hipaa,hipaa rules

Trust and Credibility

HIPAA provides assurances to your customers of your commitment to information security, illustrating your organisation as a credible and trusted partner.

We go beyond the tick-box.

Learn more about how we can align the NHS DSPT, ISO 27001 and SOC-2 with HIPAA.

Get in Touch →
8foldGovernance team — UK healthcare compliance experts
Health Insurance Portability and Accountability Act (HIPAA)

Still Learning?

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 Compliance

Understanding HIPAA Compliance: Key Insights

Read More →

April 2, 2025
The Future of AI Regulation in the US, EU and UK

The Future of AI Regulation in the US, EU and UK

Read More →

March 10, 2025
UK-US Data Transfers, Us uk data transfer uk us data transfer Data Bridge

Data Protection Update: UK-US Data Transfers

Read More →

October 12, 2023
HIPAA Compliance

Understanding HIPAA Compliance: Key Insights

Read More →

April 2, 2025
The Future of AI Regulation in the US, EU and UK

The Future of AI Regulation in the US, EU and UK

Read More →

March 10, 2025
UK-US Data Transfers, Us uk data transfer uk us data transfer Data Bridge

Data Protection Update: UK-US Data Transfers

Read More →

October 12, 2023
Read more

Frequently Asked Questions.

What is HIPAA?

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.

Do I need HIPAA to do business in the US Healthcare System?

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.

How do we become HIPAA compliant?

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.

How long does it take to become HIPAA compliant?

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.

What's the difference between HIPAA and SOC-2?

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.

Can HIPAA integrate with the NHS Data Security Protection Toolkit (DSPT) and/or ISO 27001?

Yes. There are many similarities between the requirements. Get in touch to learn more.

Get Started on Your Compliance Journey.

 Speak to a Member of our Expert Team about how you can adopt HIPAA as part of your compliance portfolio

Book Your Call Now →
8foldgovernance master

+44 (0) 1273 569172

info@8foldgovernance.com

SERVICES

  • AI Governance
  • Medical Device Registration
  • ISO Compliance
  • Full DTAC Support
  • Information Governance
  • Clinical Safety
  • Data Security & Protection
  • CQC Services
  • Cyber Security
  • 8foldTraining

LINKS

  • Contact
  • About
  • Meet The Team
  • Blog
  • Join Us
  • Case Studies
  • Charity Work
  • Partnerships
  • FAQs
DSPT Data Security And protection Toolkit 8Fold
Information Governance Badge 8 Fold
NPSORE
ABHI Member

 © 2026 8fold | Privacy Policy | Cookie Policy | Terms & Conditions

X We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies. However you may visit Cookie Settings to provide a controlled consent.
Read More ACCEPT Cookie settings
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
Save & Accept