Articles about Government

a digital dragon made of from artificial intelligence

A Step in the Right Direction – U.S. Executive Order on AI

President Biden’s Executive Order calls for stringent AI safety standards, privacy protection, responsible AI deployment in government, equity in AI applications, and international collaboration on AI safety and standards.

Medical professionals review patient health information

Update: Information Blocking Enforcement Regulations Finalized

There is now a perfect storm of ubiquitous Health IT adoption and expansive needs for interoperable health information that necessitates attention on meeting Information Blocking requirements. The HHS OIG and ONC are treating this as a top enforcement priority. Read our key takeaways and learn more about compliance strategies to avoid violations.

Woman Using Lipstick Color Makeup Simulation App On Digital Tablet, Browsing Beauty Application With Augmented Reality Option Online, Creative Collage

Are Photos Like Fingerprints? BIPA and Biometric Privacy Laws

Illinois’ BIPA is a model for upcoming biometric legislation; we expect 20% of states will have biometric privacy laws by 2024.

Tablet device showing a process of compliance in Health IT regulation, similar to the Civil Cyber-Fraud Initiative.

The DOJ’s Civil Cyber-Fraud Initiative

The most recent Health IT vendor to settle with the government is a direct result of the DOJ’s new Civil Cyber-Fraud Initiative.

Close up of hand touching smartwatch with health app on the screen, gadget for fitness active lifestyle.

FDA Releases Final Guidance on Clinical Decision Support Software as a Medical Device

Quandary Peak’s review of FDA’s final guidance leads us to believe we could see meaningful expansion of the amount of CDSS qualifying as a medical device, which could subject many current and future CDS software applications to FDA oversight.

Medical devices hanging on wall

Understanding Medical Device Cybersecurity & the FDA’s Role

As medical devices evolve to better treat and monitor patient health, cybersecurity remains a top priority. As per FDA guidance, “medical device security is a shared responsibility…”