On January 16, 2015, the Food and Drug Administration (FDA) issued a draft guidance document titled “General Wellness: Policy for Low Risk Devices.” The draft guidance carves out a category of products, deemed “general...more
The SplashData list of worst passwords of 2014 was just published, and it looks very similar to the list in 2013, 2012, 2011, etc...more
1/20/2015
Until recently, many cloud users felt like Joni Mitchell in her classic song, “Both Sides Now.” No matter how you looked at clouds, you never really understood them, how they worked, or what happened inside them. Cloud...more
Our colleages have analyzed a significant NLRB decision in Purple Communications Inc. that, in most circumstances, employees have a right to use employer email systems for non-business purposes during non-working time. This...more
12/15/2014
On December 5, 2014, the Centers for Medicare & Medicaid Services (CMS) issued a final rule titled “Requirements for Medicare Incentive Reward Program and Provider Enrollment” (“the Rule”). The Rule implemented several...more
The FTC recently filed a comment on the National Highway Traffic Safety Administration’s advance notice of proposed rulemaking related to vehicle-to-vehicle communications. The comment left no doubt that the FTC wants to...more
Last week, the HHS Office of Inspector General released a damning report on FDA’s data security: “The objective of this review was to determine whether the FDA’s network and external Web applications were vulnerable to...more
In This Presentation:
- Overview of data breach landscape
- Data breach response
..Technical best practices
..Legal best practices
- Data breach prevention
..Technical best practices
..Legal best...more
In a first for the FCC, it announced on October 24 that it intends to fine two telecom companies $10 million for data security violations...more
It’s been a while, but we have another HIPAA deadline just around the corner: September 23, 2014.
September 23, 2014 is the date by which all HIPAA business associate agreements need to be in compliance with the...more
On September 23, 2013, the Food and Drug Administration (FDA) published the final guidance on its regulation of “mobile medical applications (or apps).” The guidance finalizes FDA’s 2011 draft guidance, adding numerous...more
On February 1, 2013, Centers for Medicare and Medicaid Services (CMS) published the long-awaited Physician Payment Sunshine Act (Sunshine Act) Final Rule, implementing Section 1128G of the Social Security Act.
The...more
2/8/2013
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Medicaid ,
Medical Devices ,
Medical Supplies ,
Medicare ,
Payment Records ,
Pharmaceutical Industry ,
Physicians ,
Sunshine Act ,
Teaching Hospitals
On January 18, 2013, nearly four years after the passage of the HITECH Act and its amendments to HIPAA, and nearly three years after it proposed regulatory amendments, the U.S. Department of Health and Human Services (“HHS”)...more
On November 21, 2012, the Public Health Council promulgated final revised regulations relating to the so-called physician gift ban law, Mass. Gen. Laws c. 111N (“Chapter 111N”). Most notably, the revised regulations now...more