Healthcare technology vendors that create, receive, maintain, or transmit protected health information are obligated under HIPAA and other regulations to implement safeguards to ensure the privacy and security of patient data. This article provides an overview of key compliance considerations and best practices for vendors in the digital health space.
What is HIPAA?
The Health Insurance Portability and Accountability Act (HIPAA) is a US law passed in 1996 that establishes national standards for the protection of health information. HIPAA applies to covered entities like healthcare providers, health plans, and healthcare clearing houses as well as business associates that have access to medical records. Technology vendors that provide services involving access to patient data are considered business associates under HIPAA.
Key Provisions for Business Associate Compliance
Business associates must comply with the HIPAA Privacy, Security, and Breach Notification Rules. Key requirements include:
- Implementing administrative, physical, and technical safeguards to secure protected health information (PHI)
- Conducting risk analysis and taking steps to mitigate identified risks and vulnerabilities
- Having comprehensive HIPAA policies and procedures in place
- Entering HIPAA-compliant business associate agreements with covered entities
- Reporting data breaches involving PHI to covered entities
Importance of ISO/IEC 27001 Certification
Compliance frameworks like ISO/IEC 27001 information security management certification can help technology vendors implement HIPAA controls and best practices. ISO 27001 certification ensures vendors have an information security management system that protects confidentiality, integrity, and availability of healthcare data.
Other Relevant Regulations
In addition to HIPAA, healthcare technology vendors may need to comply with other federal and state regulations including:
- 21 CFR Part 11 - Governs records for FDA-regulated industries
- 42 CFR Part 2 - Protects substance abuse treatment records
- State data privacy and breach notification laws
By understanding applicable regulatory obligations, healthcare technology vendors can tailor their compliance programs and account for relevant requirements when developing products and services for the healthcare industry.
Best Practices for Compliance
To build an effective HIPAA and data privacy compliance program, experts recommend healthcare technology vendors take these steps:
- Perform regular risk analyses to identify and mitigate vulnerabilities
- Implement role-based access controls and need-to-know access policies
- Use encryption to protect data in transit and at rest
- Ensure third-party oversight including audits and legal reviews
- Formally designate a privacy/security officer to manage compliance
- Conduct employee awareness training on HIPAA and data protection
- Stay current on regulatory changes and update compliance plans accordingly
- Maintain comprehensive documentation of compliance activities
Streamlining Compliance
Healthcare technology vendors should look for ways to streamline compliance processes in order to reduce administrative burdens.
Leveraging automation and compliance software such as those offered by Thoropass can help organize policies, controls, and documentation in one centralized platform. Standardizing procedures across the organization and integrating compliance with business operations creates efficiencies. Vendors can also take advantage of resources like compliance checklists, model risk assessments, and self-audit tools to simplify meeting regulatory obligations.
Following best practices for compliance and achieving ISO 27001 certification enables healthcare technology vendors to effectively safeguard sensitive patient information. A comprehensive data protection program is essential for building trust and protecting the well-being of consumers.
