Jennifer Pike

Jennifer Pike

Reed Smith

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Mobile App Compliance for Dummies: New Tool Helps Developers Understand Their Legal Compliance Requirements

In a joint effort by the Federal Trade Commission (FTC), Office for Civil Rights (OCR), HHS Office of National Coordinator for Health Information Technology (ONC), and Food and Drug Administration (FDA), a new web-based tool...more

4/22/2016 - App Developers FDA FDCA FTC FTC Act HIPAA Medical Devices Mobile Health Apps OCR ONC Unfair or Deceptive Trade Practices

FDA Issues Draft Guidance on Labeling For Biosimilar Products

The federal Food and Drug Administration (“FDA”) recently published a draft guidance on labeling for biosimilar products that is intended to assist applicants in developing draft labeling for proposed biosimilar products....more

4/13/2016 - Biosimilars BPCIA Comment Period Draft Guidance FDA Labeling Prescription Drugs

After a Strong Enforcement Presence in 2015, OCR Starts 2016 with a $239,000 Civil Money Penalty Judgment

It has been a busy winter for the US Department of Health and Human Service, Office for Civil Rights (“OCR”). Since November 2015, the agency has announced three settlements and one civil money penalty judgment amounting to...more

3/4/2016 - Civil Monetary Penalty Corrective Actions Covered Entities HIPAA Audits HIPAA Breach OCR PHI

Medicare Launches Its First Mandatory Bundled Payment Model for Joint Replacement Care – What You Need to Know to Get Ready

On November 24, 2015, the Centers for Medicare & Medicaid Services (CMS) published a significant final rule that will require hospitals in selected geographic areas to participate in a new Medicare Comprehensive Care for...more

12/18/2015 - BPCI Bundled Payments CCJR CMS Hospitals Medicare

Agencies Release Proposed Overhaul of the Common Rule

On September 2, 2015, sixteen federal departments and agencies, including the US Department of Health and Human Services (HHS) released a proposed rule to modernize regulations governing human research subjects under the...more

9/4/2015 - Clinical Trials Comment Period Ethics FDA Federal Register HHS Human Rights Informed Consent IRB Life Sciences Medical Research NPRM Proposed Regulation Scientific Research

FDA Announces Medical Device User Fee Rates for Fiscal Year 2016

Earlier this week, the federal Food and Drug Administration (FDA) issued a notice in the Federal Register (80 Fed. Reg. 46033) announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY)...more

8/7/2015 - Comment Period FDA FDCA Federal Register Fees Medical Devices Premarket Approval Applications

FDA Final Rule Mandates Drug Manufacturer Notification of Impending Drug Shortages

On July 8, 2015, the federal Food and Drug Administration (FDA) published a final rule requiring drug manufacturers to report to the Agency any supply chain disruptions that could lead to drug shortages. The final rule...more

7/24/2015 - Advance Notice Email FDA FDASIA Final Rules Generic Drugs Notifications Pharmaceutical Industry Prescription Drugs Supply Chain

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 Industry 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 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 Industry 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

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