What Every Healthcare Organization Should Know About FIPS Validation

Healthcare’s digital transformation has created unprecedented opportunity—and unprecedented risk. The U.S. Government’s Administration for Strategic Preparedness and Response (ASPR) paints a dire picture when it comes to healthcare and public health cybersecurity. It reports that the Healthcare and Public Health (HPH) sector continues to experience increasingly sophisticated cyberattacks that exploit complex, interconnected IT systems at hospitals and healthcare facilities.

Moreover, the American Hospital Association wrote that healthcare had more cyberthreats last year than any other critical infrastructure industry, according to the FBI’s 2024 Internet Crime Report.

Nationwide, ASPR reports that healthcare and public health IT infrastructures suffer from many common vulnerabilities: underfunded cybersecurity programs, vulnerable legacy systems, a growing need for skilled cybersecurity professionals, and network-connected medical technologies, including medical devices and clinical workstations.

How can healthcare facilities protect themselves from these vulnerabilities? 

Cybersecurity has become an operational mandate for IT professionals managing connected fleets of workstations, whether across just one or multiple campuses. The most resilient healthcare organizations are those aligning with technology partners that design end-to-end secure architecture—from device to network and data—and can demonstrate it through recognized federal validation.

The strongest marker of trusted encryption is validation under the Federal Information Processing Standards, or FIPS. When software and hardware solutions meet this standard, it means a trusted third party has tested and verified that their encryption works as claimed. Choosing FIPS validated solutions helps your organization reduce the risk of damaging cyber incidents and gives you real proof that you’re protecting patient information in line with laws and industry expectations.

Defining FIPS and its Significance for Healthcare

FIPS is the highest benchmark for ensuring security through software and hardware encryption requirements. The U.S. federal government sets the bar for this standard that protects sensitive but unclassified information using cryptography, but its relevance and value extend to every sector utilizing connected devices processing sensitive and personal information. Simply put, FIPS matters everywhere platform security matters. Like federal information, healthcare requires the strongest protection measures for encryption to ensure security of sensitive data and personal information in mobile and networked technologies.

FIPS validation is governed by the certifying body NIST (National Institute of Standards and Technology). Only FIPS validated products are tested, certified, and listed on NIST’s website. FIPS 140-3 is the current standard and includes all requirements from the prior 140-2 standard, plus more stringent controls. Working with the most current FIPS validated products provides assurance that you’re working with products that have passed the highest standard for federal software encryption requirements.

When it Comes to FIPS, Terminology Matters

Healthcare providers know the importance of specificity. Being exact. That’s also true when it comes to terminology suppliers use around FIPS. Some vendors blur the line between FIPS compliant and FIPS validated. While compliance merely suggests adherence to guidelines, validation proves it. Accepting anything less than FIPS validation is an invitation for data security risk and vulnerability.

A product is FIPS validated in the U.S. only when it has been tested, verified, and issued a certificate by NIST. A FIPS validated module is public, searchable, and auditable. Before adopting connected solutions, best practices for IT teams should include confirming validation status directly on NIST’s website under their validation program. It’s an easy step that separates marketing language from measurable security posture.

Five Benefits of FIPS Validation for Healthcare IT

There are many benefits to relying on FIPS 140-3 validated cryptographic modules, including:

1. Encryption Integrity

FIPS validated cryptographic modules have been rigorously tested for tamper resistance, key management, and secure cryptographic operations, ensuring protection for every data exchange in a network. For a healthcare facility, this means patient records, connected medical devices, and internal communications are protected with independently verified encryption—not assumptions or unbacked vendor claims.

2. Risk Mitigation

When encryption is weak, mis-configured or unvalidated, attackers have easier paths into your data or systems. The healthcare sector is especially vulnerable to breaches and ransomware, but by using FIPS validated modules, you reduce the chance of a weak spot in your encryption layers being the cause of a violation.

3. Patient Trust and Confidence

Patients trust healthcare providers not only with their care but with highly personal data. If a cyber security breach happens, trust is shattered, reputation damaged, and recovery harder. Using certified encryption shows patients that data protection isn’t assumed—it’s proven. For patients, it means their sensitive health information is handled securely and with care, which can improve confidence in your facility and, in turn, support retention, referrals, and overall satisfaction.

4. Assurance for Leadership

For CIOs, CTOs, and boards, the continuous worry about “what if” something goes wrong can be exhausting. Having FIPS validated encryption means one less major risk area to fret over. Because the modules are tested, documented, and part of a government recognized program, you can feel more confident that you are meeting key technical standards with auditable evidence.

5. Regulatory Compliance

Healthcare organizations must meet a host of regulatory requirements (i.e., Health Insurance Portability and Accountability Act (HIPAA) in the U.S.). While HIPAA doesn’t explicitly say “must use FIPS 140-3”, guidance makes clear that encryption should use validated cryptographic mechanisms and that modules should be properly tested. Adopting FIPS validated tools streamlines documentation for HIPAA, HITECH, and NIST CSF audits—reducing cost, risk, and remediation burden.

FIPS validation should be on your procurement checklist. As hospitals expand their use of connected workstations, mobile clinical devices, and IoT-enabled technologies, only solutions built on FIPS 140-3 validated cryptography provide the independently verified assurance needed to protect sensitive data at scale. By standardizing platforms that meet this federal benchmark, your organization takes a clear and confident step toward ensuring your facility is prepared, keeping data secure, preventing operational disruptions, building trust with patients and staff, and remaining focused on what matters most: delivering quality care.