Navigating HIPAA and HITRUST as a Health Tech Startup

In the healthcare space, building a strong cybersecurity and compliance program can feel like a moving target. Organizations that create, store, transmit, or process protected health information (PHI) not only have to contend with regulatory requirements, but also with customers and partners who have high standards for security and privacy.

For health tech startups, establishing a strong security foundation early can help transform compliance from a regulatory burden into a strategic advantage—strengthening trust with customers and stakeholders while supporting long-term growth.

Here’s the big picture:

• HIPAA establishes the foundation. Organizations that meet HIPAA’s definition of a covered entity or business associate have a legal obligation to protect PHI and ePHI.
• HITRUST provides independent validation. HITRUST offers certification options that provide varying levels of assurance, including an e1 certification specifically designed for early-stage startups.
• A scalable compliance strategy starts with strong internal risk management processes. Conducting a HIPAA risk assessment, documenting policies and procedures, managing vendor risk, and strengthening access controls can help startups build a foundation for future compliance efforts.

Let’s dive deeper.

What is HIPAA?

The Health Insurance Portability and Accountability Act (HIPAA) was first signed into law in the U.S. in 1996 to establish policies and procedures for maintaining the security and privacy of individually identifiable health information, also known as protected health information (PHI). 

The law not only defines standards, but also outlines offenses and creates civil and criminal penalties for violations.

In the early 2000s, the HIPAA Privacy Rule was added to ensure individuals’ health information is properly protected while allowing the flow of health information needed to provide high-quality healthcare and protect the public’s health and well-being.

In 2005, the U.S. Department of Health and Human Services (HHS) created the HIPAA Security Rule, which added regulations for protecting patients’ electronic PHI (ePHI) and preventing it from being disclosed without the patient’s consent.

HIPAA applies to “covered entities”—including healthcare providers, health plans, and healthcare clearinghouses—as well as “business associates,” individuals and organizations outside of these covered entities that use or disclose individually identifiable health information to perform or provide services.

Unlike frameworks such as SOC 2, which organizations may choose to adopt, HIPAA compliance is mandatory for organizations that meet these definitions.

The HIPAA Privacy Rule

The HIPAA Privacy Rule encompasses several key elements designed to protect patient information. This includes the “Minimum Necessary” standard, which requires PHI to be disclosed only to the extent necessary to accomplish the intended purpose. The rule also mandates that covered entities provide patients with a Notice of Privacy Practices, informing them of their rights and how their information will be used and disclosed.

Another critical element is the requirement for covered entities to obtain patient authorization before using or disclosing PHI for purposes not otherwise permitted by the rule. Patients also have the right to access their medical records, request corrections, and receive an accounting of disclosures of their PHI.

These HIPAA rights provide patients with significant protections for their personal health information. Patients have the right to receive a copy of their health records and request that corrections be made to any inaccuracies. They can also specify restrictions on certain uses and disclosures and have the right to be informed about privacy practices and their rights under the rule.

For health tech startups, these requirements reinforce the importance of understanding how PHI is handled throughout the organization. Establishing clear policies and procedures, defining how information is used and disclosed, and ensuring appropriate safeguards are in place can help organizations protect sensitive information while maintaining compliance.

The HIPAA Security Rule

While the HIPAA Privacy Rule focuses on privacy and the appropriate use and disclosure of PHI, the HIPAA Security Rule establishes safeguards for protecting ePHI. These safeguards fall into three categories:

• Administrative: This includes controls related to risk analysis and risk management, termination procedures, access authorization, password management, data backup plans, and disaster recovery plans.
• Physical: This includes controls related to facility access, workstation use and security, and device and media controls such as data backup and storage.
• Technical: This includes controls related to unique user identification, emergency access procedures, encryption, and decryption.

Together, these safeguards are intended to protect the confidentiality, integrity, and availability of ePHI while protecting against reasonably anticipated threats and unauthorized disclosures.

For startups, establishing these controls early can help build the foundation for a security program that is ready to grow as your business scales. But effective HIPAA compliance requires more than simply implementing technology. Organizations should clearly define who has access to ePHI and why, what security measures are in place, and how incidents are detected and handled.

Using HITRUST to Demonstrate Security

HIPAA does not have a formal certification that organizations can obtain to prove compliance. However, organizations that want to provide assurance to customers that they adhere to the security standards outlined by HIPAA have several options.

One option is to obtain a report on HIPAA compliance provided by a third-party auditing firm. Another is to pursue compliance with a framework that incorporates elements of HIPAA into its requirements, such as HITRUST, an internationally accepted standard for security compliance that was designed with HIPAA in mind.

The HITRUST CSF is a comprehensive, threat-adaptive standard designed to help organizations strengthen their security posture and build trust with customers, partners, and stakeholders. Recognized internationally, HITRUST stands out for its flexibility and responsiveness to emerging threats.

HITRUST offers three assessment options with varying levels of assurance:

• e1 certification: Covers 44 foundational security controls and is ideal for low-risk organizations and early-stage startups looking to demonstrate adherence with baseline security best practices.
• i1 certification: Adds 138 controls, for a total of 182, and provides a moderate level of assurance for businesses with more robust information security programs and greater assurance needs.
• r2 certification: Designed for organizations with complex environments that need the highest levels of assurance. The most rigorous of the three options, the r2 requires 200 or more controls, depending on the scope of the assessment.

For startups that are just getting started in their cybersecurity journey, pursuing e1 certification is a smart option that can pave the way for more robust assessments in the future. As your organization grows, you can build on that established cybersecurity foundation with a higher-level assessment, such as the i1 or r2.

The goal isn’t to pursue every framework at once. It’s to understand where your organization is today, where you want to go, and which compliance initiatives will best support that journey. 

By taking a structured, proactive approach to compliance, health tech startups can transform security from a regulatory obligation into a foundation for trust, growth, and long-term success.

Contact us today to find out how we can help.