Managing HIPAA For Medical Devices

Build and automate your HIPAA Security Program. Meet all regulatory requirements for managing protected health information (PHI) across medical devices and IT infrastructure.

Download Your Guide To Managing HIPAA In The Cloud

Challenges of HIPAA Compliance For Medical Devices

Medical Device and MedTech companies need to address HIPAA security and compliance controls when managing patient data and protected health information (PHI). As MedTech organizations prepare for clinical trials, FDA clearance, and key partnerships, it is critical that all HIPAA requirements are being met for PHI stored across infrastructure and cloud providers, as well as any PHI locally on medical devices and mobile devices.

This means that organizations need to manage administrative. technical, and physical safeguards required by HIPAA/HITECH:

Developing HIPAA Security Program & Administrative Policies
Handle Medical Device Security & Compliance
Implementing Device & Transmission Encryption
Managing Security of PHI Data In The Cloud
Implementing Access Control Standards

Building A HIPAA Security Program For Medical Devices

To satisfy HIPAA/HITECH compliance requirements, medical device companies should develop administrative policies for the organization and implement all necessary technical controls across the IT infrastructure.

Dash ComplyOps helps healthcare and MedTech teams quickly generate HIPAA administrative policies, implement technical security controls, and automate remediation of compliance issues. Dash provides security teams with a solution for managing HIPAA requirements including:

Frequently Asked Questions

How Does SOC 2 and HITRUST Fit Into Security Programs?

Cybersecurity standards such as SOC 2 and HITRUST are security assessment frameworks that companies choose to get certified for. Many healthcare companies choose to get these certifications to validate security standards for clients, partners, and enterprises.

HIPAA on the other-hand is a compulsory regulation. Organizations managing PHI are required to meet HIPAA security requirements.

What HIPAA Technical Safeguards Are Required For Medical Devices?

Medical Device and MedTech companies managing patient data in the cloud, must implement cloud security controls including encryption, audit logging, and backup/disaster recovery.

MedTech companies storing/processing patient data locally on devices must also ensure this data is encrypted, audited and protected at-rest and in-transit.

Developing Your HIPAA Security Program

Create Security Policies

Build your HIPAA administrative policies, by answering plain-English questions about your organization/technologies.

Implement Cloud Security Controls

Set required technical security controls including – encryption, access control, audit logging, backup and disaster recovery standards.

Set Device Security Controls

Implement necessary protections for data on medical device and mobile devices.

Download Your Guide To Managing HIPAA In The Cloud