ISO 27001 and Cardiac Remote Monitoring: What Health Systems Need to Know Before They Sign

Before you sign with a CIED monitoring vendor - or renew with your current one - ask one question: what security certification do you hold, and who issued it? 

For most platforms, the answer is HIPAA compliance and SOC 2. Both are important. Neither is the international gold standard.

HIPAA Is a Floor

HIPAA sets the minimum standard for protecting patient health information in the U.S. Every healthcare technology vendor must comply. But compliance is self-assessed, enforcement is complaint-driven, and a vendor can be fully HIPAA compliant and still have significant gaps in their actual security posture.

SOC 2 goes further - it's an independent attestation of controls across security, availability, and confidentiality. But it doesn't require continuous improvement, and the scope of what gets audited varies significantly between certifications.

Both matter. Neither is ISO/IEC 27001:2022.

ISO/IEC 27001:2022 Is a Ceiling

ISO/IEC 27001:2022 is the international standard for Information Security Management Systems. It's what global financial institutions, defense contractors, and the world's most security-conscious enterprises operate under.

Getting certified requires organizations to build, independently audit, and continuously improve a comprehensive security program across 93 controls - spanning access management, cryptography, incident response, supplier relationships, and business continuity. It's not a one-time assessment. It's an ongoing commitment.

The 2022 designation matters. This is the most current version of the standard, updated to address modern cloud environments and the threat landscape as it exists today.

For health system IT and security leaders, ISO/IEC 27001:2022 certification from an ANAB-accredited body simplifies vendor security reviews. A verified cert means your team starts with an independently confirmed answer - not a questionnaire.

The CIED Monitoring Landscape

Healthcare cyberattacks aren't slowing down. High-profile incidents at various healthcare facilities have moved vendor security from a back-office IT concern to a board-level conversation. The bar is rising. Health system procurement teams are asking harder questions.

There is now a certified standard for protecting your patients' cardiac data.

PaceMate® Is ISO/IEC 27001:2022 Certified

On May 26, 2026, PaceMate® received ISO/IEC 27001:2022 certification (Certificate #ISMS-PA-052626) from A-LIGN Compliance and Security, Inc., an ANAB-accredited certification body and member of the International Accreditation Forum. PaceMate® is one of the few CIED remote monitoring platform in the United States certified to this standard.

For health systems already partnering with PaceMate®: your vendor's security posture has been independently verified at the highest international standard. Your patients' cardiac data is protected accordingly.

What to Ask at Your Next Vendor Review

Ask every vendor on your shortlist for their ISO/IEC 27001 certification - specifically the 2022 edition - from an accredited body. Ask which operations are in scope and when the certification was last renewed.

The answers will tell you everything you need to know.

Your patients don't get to choose their monitoring platform. You do.

Choose the one that's certified to protect them.

PaceMate®'s ISO/IEC 27001:2022 certificate is available upon request.