Jennifer Pike

Jennifer Pike

Reed Smith

Contact  |  View Bio  |  RSS

Latest Publications

Share:

OCR Announces Settlement and Corrective Action Plan with Pharmacy Stemming from Alleged Violations

On April 24, 2015, the HHS Office for Civil Rights (“OCR”) once again stressed the importance of properly disposing of protected health information (“PHI”) when it announced its settlement and corrective action plan with...more

5/15/2015 - Data Breach Document Destruction Healthcare HIPAA OCR Pharmacies PHI

FDA Issues Three Biosimilar Final Guidances

On April 28, 2015, the federal Food and Drug Administration (FDA) finalized three guidances for industry on developing biosimilar drugs. The guidances, which follow the FDA’s first approval of a biosimilar drug in March, are...more

5/12/2015 - Biosimilars FDA Final Guidance Pharmaceutical Manufacturers Prescription Drugs

Amidst Increasing Security Concerns, Medicare to Drop Social Security Numbers from Cards

In an effort to combat growing concerns of identity left, President Obama signed into law last week a bill that will require the removal of Social Security Numbers (SSNs) from all Medicare beneficiary cards. The change, which...more

4/27/2015 - Barack Obama Data Protection HIPAA Medicare Social Security Numbers

FDA Releases Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Abroad

On April 21, 2015, the Food and Drug Administration (FDA) issued a notice announcing the availability of a draft guidance document clarifying the Agency’s acceptance of medical device clinical data from studies conducted...more

4/27/2015 - Clinical Trials FDA Humanitarian Device Exemption Investigational Device Exemptions Life Sciences Medical Devices

FDA One Step Closer to New Direct-To-Consumer Television Ad Requirements

Last February, the Food and Drug Administration (FDA) asked for public feedback on a proposed research study related to prescription drug television advertisements. In a notice published in the Federal Register on January 13,...more

1/22/2015 - Advertising FDA Market Research OMB Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Television Commercials

Network Interference: A Legal Guide to the Commercial Risks and Rewards of the Social Media Phenomenon (3rd Edition)

In this edition: - Introduction - Advertising & Marketing - Brand Protection & Reputational Management - Copyright (EU) - Copyright (U.S.) - Data Privacy & Security -...more

4/24/2014 - Copyright Cybersecurity Data Protection EU FDA Social Media Trademarks UK

The HITECH Final Rule: The New Privacy/Security Rules of the Road Have Finally Arrived

Since the 2009 enactment of the Health Information Technology for Economic and Clinical Health Act (the “Act” or “HITECH Act”), compliance efforts associated with the Health Insurance Portability and Accountability Act of...more

2/20/2013 - Business Associates Data Protection HIPAA HIPAA Omnibus Rule HITECH IFRS Medical Records Patient Privacy Rights PHI Subcontractors

7 Results
|
View per page
Page: of 1

All the intelligence you need, in one easy email:

Great! Your first step to building an email digest of JD Supra authors and topics. Log in with LinkedIn so we can start sending your digest...

Sign up for your custom alerts now, using LinkedIn ›

* With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name.
×