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.
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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.
Read MoreCalifornia’s Sweeping New Privacy Laws
California state legislators passed a sweeping digital privacy law at the end of June, giving consumers increased control over their online data. The legislation also gives internet users in the state greater insight into how their information is collected and spread by technology companies. The bill, which evolved from draft into law in less than […]
Read MoreEurope’s New Privacy Laws Mean Field Day for Lawyers and Activists
The European Union’s new data-protection rules are officially in effect. The General Data Protection Regulation (GDPR) is the world’s most stringent set of regulations to protect internet users’ online data, and its effects are reverberating far beyond Europe. In this post we examine the details of the GDPR, the circumstances that led to its adoption, […]
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