Mobile Medical Apps & FDA Rules: What is the latest in 2017?

December 3rd, 2017|0 Comments

In the world of mobile apps, things change quickly, and it stands to reason that, as mobile phone makers added better processors, cameras, gyroscopes, and accelerometers, software [...]

EU Medical Device Industry: Regulatory and Privacy M&A Issues for a US Company

December 3rd, 2017|0 Comments

For US healthcare companies considering an acquisition of a medical device or in vitro diagnostics company in the EU or that has a material part of its [...]

FDA’s Guidance on Real-World Evidence for Medical Devices: Great for Class III Registry Participants, But What About the Rest of MedTech?

September 13th, 2017|0 Comments

On August 31, 2017, the FDA issued a final version of a guidance entitled, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices[i]” and, while [...]

Jeremy Shapiro-Barr and Robyn Shapiro Present to the Wisconsin Bar

April 27th, 2017|0 Comments

On April 18, 2017, Jeremy and Robyn presented two State Bar of Wisconsin webcasts focusing on recent developments in privacy and data security law.  In the programs, [...]

OCR Releases Guidance on HIPAA & Cloud Computing

October 24th, 2016|0 Comments

In guidance issued on October 6, OCR has clarified that cloud service providers (CSPs) who create, receive, maintain or transmit electronic PHI on behalf of their customers [...]

CMS Releases 2015 Open Payments Data – Value to the Public Still Not Clear

July 7th, 2016|0 Comments

CMS recently released Open Payments data submitted by applicable pharmaceutical and medical device manufacturers for calendar year 2015, and it is now available here. The 2015 data [...]

OCR Guidance on Ransomware Attacks Forthcoming

July 6th, 2016|0 Comments

In a recent letter to Deven McGraw, Deputy Director for Health Information Privacy at the Office of Civil Rights (OCR), congressmen Ted Lieu and Will Hurd urged [...]

Unauthorized Filming at NY Presbyterian Hospital Results in $2.2 Million Settlement

June 10th, 2016|0 Comments

A recently publicized HIPAA breach at New York-Presbyterian Hospital involved unauthorized filming by a television film crew from ABC’s “NY Med,” a medical documentary series, of two [...]

Change is in the air

May 10th, 2016|0 Comments

You can almost smell it; Change is coming to the Clinical Research enterprise! At the ACRP 2016 Meeting & Expo in Atlanta last month, John Neal, CEO [...]

Massive Anti-Kickback, False Claims, and FCPA Settlements for Life Sciences Companies

April 18th, 2016|0 Comments

In March 2016, two global life sciences companies agreed to pay hundreds millions of dollars in fines to resolve claims under the federal Anti-Kickback Statute (AKS)[i], the [...]

Individuals’ Rights to Access Their Personal Health Information: New Guidance

April 15th, 2016|0 Comments

On January 7, 2016, the Office of Civil Rights released a new guidance document clarifying the rights of individuals to access protected health information (PHI) about them [...]

Open Payments 2015 Calendar Year Reporting Period Now Closed; Prepare for Reporting 2016 Data

April 8th, 2016|0 Comments

The Open Payments reporting period for payments made in calendar year 2015 by applicable pharmaceutical, device, biological, and medical supply manufacturers to physicians and teaching hospitals ended [...]