Is Secure File Transfer (SFTP/MFT) Software HIPAA Compliant?

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Secure file transfer software using Secure File Transfer Protocol or managed file transfer is HIPAA compliant when the implementation protects electronic protected health information with safeguards required by the HIPAA Security Rule, limits uses and disclosures under the HIPAA Privacy Rule, supports breach response obligations under the HIPAA Breach Notification Rule, and includes a signed HIPAA Business Associate Agreement when the vendor creates, receives, maintains, or transmits protected health information on behalf of a HIPAA Covered Entity or Business Associate.

Secure File Transfer Protocol is a transport method that can protect data in transit, but HIPAA compliance depends on the full system design and operating controls. A compliant deployment includes secure user authentication, restricted access aligned to workforce role, audit logging that supports review of file access and transfer activity, and controls that prevent users from exporting protected health information into unmanaged locations. Managed file transfer platforms add workflow features such as automation, routing, retention, and reporting, which expand the compliance scope to include stored files, temporary processing locations, metadata, transfer history, and administrative access paths.

A HIPAA Business Associate Agreement is required when a hosted SFTP server or managed file transfer provider handles protected health information for a regulated customer. A provider that is not willing to sign a HIPAA Business Associate Agreement for services involving protected health information is not appropriate for HIPAA regulated file transfer. HIPAA compliant SFTP server offerings are expected to support a HIPAA Business Associate Agreement as a baseline contracting condition, and procurement should confirm that the agreement covers the specific service tier, storage model, support access, and any subcontractors involved in hosting or processing.

Accredited HIPAA Certification

Security controls should address both transmission and storage. Transmission protections should be implemented for all connections, including partner connectivity, application programming interface integrations, and automated workflows. Storage protections should apply to files at rest, queued transfers, archival repositories, backups, and any replicated environments used for continuity. Administrative controls should include account provisioning and termination, periodic access review, configuration management, and monitoring of anomalous access or transfer patterns.

Operational procedures determine whether secure file transfer remains compliant after deployment. Organizations should define approved use cases, file naming and handling rules, permissible recipients, and retention periods for inbound and outbound files. Procedures should address failed transfers, retransmissions, quarantine of suspicious files, and secure deletion aligned to records management requirements. If the platform supports email notifications, download links, or browser-based sharing, those features require configuration controls to prevent disclosure through message previews, external forwarding, or unauthenticated access.

Incident response expectations apply to secure file transfer platforms. The organization should be able to investigate misdirected transfers, unauthorized downloads, compromised credentials, and vendor security events affecting stored or transmitted protected health information. Breach assessment and notification decisions must follow the HIPAA Breach Notification Rule and align with the vendor’s contractual reporting obligations in the HIPAA Business Associate Agreement.

Secure file transfer software supports HIPAA compliance when the organization can demonstrate a completed risk analysis for the deployment, implemented safeguards for electronic protected health information throughout the transfer and storage lifecycle, enforced operational controls for recipients and retention, and a signed HIPAA Business Associate Agreement when the vendor’s services involve protected health information.

James Keogh

James Keogh has been writing about the healthcare sector in the United States for several years and is currently the editor of HIPAAnswers. He has a particular interest in HIPAA and the intersection of healthcare privacy and information technology. He has developed specialized knowledge in HIPAA-related issues, including compliance, patient privacy, and data breaches. You can follow James on Twitter https://x.com/JamesKeoghHIPAA and contact James on LinkedIn https://www.linkedin.com/in/james-keogh-89023681 or email directly at [email protected]