Health Information Technology

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Last week, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance, which details the agency’s recommendations for monitoring, identifying, and addressing cybersecurity vulnerabilities in medical devices after they have…

In the last two weeks, the Office for Civil Rights (OCR) announced two substantial settlements under HIPAA that together totaled $4.35 million. These large amounts seem to be driven not by actual harm to individuals, but in significant part by alleged HIPAA compliance failures identified by OCR following investigations commenced in response to receipt of…

Responding to a Department of Health and Human Services Office of Inspector General (OIG) report recommending stronger oversight of covered entities’ compliance with the HIPAA Privacy Rule, the Office for Civil Rights (OCR) stated that in early 2016 it will launch Phase 2 of its audit program measuring compliance with HIPAA’s privacy, security and breach…

Bloomberg BNA (subscription) recently reported that this fall the Center for Democracy & Technology (CDT) will be issuing a report on Fitbit Inc.’s privacy practices. Avid runners, walkers or those up on the latest gadgets likely know about Fitbit, and its line of wearable fitness devices. Others may know about Fitbit due to the need…

According to a Bloomberg article, the second phase of HIPAA audits by the Office for Civil Rights (OCR), originally set to commence in 2014, may be coming soon. This update came at a HIPAA conference co-hosted by OCR during which OCR Director Jocelyn Samuels said the agency was in the process of confirming contact…

On September 2, the Office for Civil Rights (OCR) reported that it agreed to settle potential violations of the HIPAA privacy and security regulations with Cancer Care Group, Inc. The dollar amount of the settlement, $750,000, is significant, and the agreement to adopt a robust, multi-year corrective action plan under the watchful eye of the…

The saying – never let them see you sweat – soon may be more difficult to accomplish with Microsoft’s Hololens. Like Google Glass, the Hololens is worn as a headset. But this device has a “plurality” of sensors that gather a range of biometrics parameters (heart rate, perspiration, etc.) which determine along with other…

In June, Connecticut’s governor signed into law Senate Bill 949 which amended the State’s breach notification statute. The requirement that covered businesses must provide one year of identity theft protection services for certain breaches, easily the most popular aspect of the legislation, may have diverted attention from some significant aspects of this new law.…

As reported on our Benefits Law Advisor, the EEOC has issued proposed wellness program regulations. Much of the attention to those proposed rules understandably will be how they would affect the incentives employers have implemented to spur their employees to engage in healthier behaviors. The proposed rules also address, however, the confidentiality provisions under…

During this year, businesses will be hearing a lot about the Affordable Care Act’s (ACA’s) information reporting requirements under Code Sections 6055 and 6056. Information gathering will be critical to successful reporting, and there is one aspect of that information gathering which employers might want to take action on sooner rather than later – collecting…