The members of the Health Law and Life Sciecnes Committee write extensively on topics pertinent to health care providers and life sciences companies. The following are articles, alerts and analyses of national interest submitted by our members and organized by subject matter. If you are a Committee member and would like to have your article or publication considered for posting on this website, please contact William Roberts, the Health Law Committee’s Content Director, at wroberts@goodwin.com.
Data Privacy and Security
HIPAA Final Rule
February 12, 2013
Shipman & Goodwin LLP
On January 17, 2013, the U.S. Department of Health and Human Services released the long-anticipated final rule modifying the Health Insurance Portability and Accountability Act’s (“HIPAA”) privacy, security, breach notification and enforcement rules. Covered entities and business associates will have until September 23, 2013 to comply with most of the major provisions of the final rule.
After a Two-And-A-Half Year Wait, HHS Finalizes Modifications to HIPAA Rules: Prepare Now for Changes
January 23, 2013
Bass Berry Sims, PLC
On January 17, 2013, the U.S. Department of Health and Human Services ("HHS") issued the highly anticipated omnibus final rule (the "Final Rule") to modify the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") pursuant to the Health Information Technology for Economic and Clinical Health Act ("HITECH"). Following the enactment of HITECH, HHS issued interim final rules to implement the breach notification requirements and certain of the enforcement provisions of HITECH (collectively, the "Interim Rules"), and in July of 2010 HHS issued a proposed rule to implement modifications to the privacy and security provisions of HIPAA. Since that time, Covered Entities and their Business Associates and subcontractors have been awaiting the Final Rule to confirm the extent to which these modifications, which are aimed primarily at strengthening the privacy and security protections for protected health information ("PHI") and tightening the HIPAA enforcement provisions, will impact their operations, contractual relationships and potential exposure for HIPAA liability.
Life Sciences Corporate & Regulatory
CMS Issues Physician Payments Sunshine Act Final Rule: Reporting Requirements for Manufacturers of Drugs, Devices, Biologicals and Medical Supplies and Group Purchasing Organizations
February 28, 2013
Shipman & Goodwin LLP
The Centers for Medicare and Medicaid Services (CMS) recently issued final regulations to implement the reporting and transparency requirements set forth in the Patient Protection and Affordable Care Act, also known as the Physician Payments Sunshine Act. The final regulations require certain manufacturers of drugs, devices, biologicals or medical supplies to report to CMS certain payments or transfers of value to physicians and teaching hospitals. The Final Rule also requires such manufacturers and certain group purchasing organizations to report certain ownership and investment interests. We have prepared this alert to provide an overview of the requirements imposed by the Final Rule.
Final Sunshine Rule - Get Ready to Start Tracking Data
February 26, 2013
Bass Berry Sims PLC
On February 8, 2013, after a long delay, the Centers for Medicare & Medicaid Services ("CMS") published in the Federal Register the final rule ("Final Rule") implementing the Physician Payment Sunshine Act ("Sunshine Act") enacted pursuant to section 6002 of the Affordable Care Act. The Final Rule, while largely in line with the proposed rule, makes some helpful clarifications and simplifies the requirements for reporting research payments.
FDA Releases Guidance on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices
June 11, 2012
Shipman & Goodwin LLP
The Food and Drug Administration (FDA) released draft guidance addressing how pharmaceutical and medical device manufacturers and distributors should respond to unsolicited requests for off-label information about their FDA-approved products. The guidance was issued in response to industry feedback from 2009 hearings regarding social media marketing. It is the first of multiple planned policy recommendations by FDA on marketing practices and emerging electronic media.
FDA and HHS Rules on Disclosure of Conflicts of Interest in Research
May 2, 2012
Shipman & Goodwin LLP
The issue of potential conflicts of interests by those engaged in research is not new. However, within the last twelve months, two Federal agencies have published guidance with respect to disclosures of conflicts of interest by those engaged in clinical research. The following sets forth a summary of the current Food and Drug Administration (“FDA”) requirements with respect to financial conflicts of interest and where noted, incorporates provisions of a draft guidance that was issued by the FDA in 2011. The summary also includes the U.S. Department of Health and Human Services (“HHS”) requirements with respect to financial conflicts of interest held by researchers including new provisions that go into effect on August 24, 2012. The summary should be used only as a guide and is not intended to replace the need for you to review the FDA or HHS regulations in their entirety and/or to seek legal counsel with respect to your set of facts as these rules are subject to agency interpretation.
