Compliance & Legal

The U.S. Food and Drug Administration has published updated draft recommendations to help improve the performance of pulse oximeters across skin tones.

After resolving how it will review updates to previously approved artificial intelligence-enabled medical devices, the agency will release its full draft proposal for market submissions.

Through a recently completed multipronged red-teaming effort, the agency said it will develop repeatable testing datasets that can be used to evaluate large language model tools and services in the future.

For many healthcare organizations (HCOs) working in a cloud environment, data visibility issues can present a challenge to maintaining regulatory compliance. ClearDATA’s CyberHealth™ Platform provides a real-time overview of an HCO’s data landscape, and its automated safeguards and controls with remediation steps enhance data security and compliance in the cloud.

With a majority of healthcare organizations lacking proper technology to address HIPAA compliance, it’s imperative that quick action is taken to avoid serious security and data privacy breaches. Our comprehensive guide provides you with all you need to know to address this time-sensitive issue.

By creating new definitions and revising others, the proposed rule targets health and wellness technology companies operating outside of HIPAA and qualitatively expands the scope of what constitutes a PHR.

Healthcare organizations must urge the Senate to pass critical telehealth legislation, and enact at least a two-year extension of the important PHE-era policies while working toward a permanent solution.

Compliance is a serious, enforceable matter – and must be properly addressed in the context of the workplace challenges and changes that have emerged amid the pandemic. 

On the surface, like with other HHS settlements, it may seem harsh, regarding only the amount of money vis-a-vis the number of patients affected. But it's important to consider what OCR is trying to accomplish.

When working with big data, small inconsistencies in data entry matter. Leaving the task of cleaning up registration or demographic data to data scientists or IT staff will be expensive.