Health Science, Computers & Technology

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
News & Analysis as of

Blog: OIG Releases Advisory Opinion Regarding Laboratory and Physician Practice Agreement

On March 25, 2015, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion No. 15-04. In the opinion, the OIG addresses a laboratory’s proposal to enter into agreements...more

OIG Finds Exclusive Lab Arrangement May Violate Anti-Kickback Statute

Yesterday the Office of Inspector General for the Department of Health and Human Services (the “OIG”) issued Advisory Opinion 15-04 (“Advisory Opinion”) in which it found that an exclusive arrangement between a laboratory...more

Congressional Health Policy Hearings

Congressional committees have held several hearings this week on health policy issues. On March 24, the Energy and Commerce Health Subcommittee held a hearing on the 340B drug pricing program....more

340B Drug Pricing Program Questioned by Congressional Subcommittee

In This Issue: - Recent Developments for Multiemployer Pension Plans - Witness Statements - Questions & Answers - For More Information - Excerpt from Recent Developments for Multiemployer...more

Update on the DOJ's Criminal Investigation into Generic Pharmaceuticals

The Department of Justice Antitrust Division's (DOJ's) investigation into the generic pharmaceutical industry may be expanding. On March 15, 2015, a third generic manufacturer disclosed that it received a subpoena from the...more

FDA Issues Draft Guidance on Use of Electronic Informed Consent in Clinical Trials

On March 9, 2015, the U.S. Food and Drug Administration (FDA) released a draft guidance, Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers, that provides recommendations for clinical...more

Increased FTC Enforcement as FDA Deregulates Low-Risk Health IT Devices

The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices. In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement...more

HHS Releases Two Healthcare Information Technology Proposed Rules

On March 20, 2015, CMS and the HHS Office of the National Coordinator for Health Information Technology (ONC) released proposed rules regarding Stage 3 of the Medicare and Medicaid Electronic Health Records (EHRs) Incentive...more

Failure to Warn About Dangers of Off-Label Use of Medical Device Preempted Under Federal Law

In Thorn v. Medtronic Sofamor Danek, USA, the Honorable Janet T. Neff dismissed the plaintiff's state law claims of failure to warn and negligence as preempted under the Medical Device Amendments of 1976 ("MDA"), 28 U.S.C. §...more

OIG Advises that Exclusive Lab Referral Arrangement May be a Kickback

The Department of Health and Human Services Office of Inspector General (OIG) released an advisory opinion (No. 15-04) today that states a proposed arrangement to provide free laboratory tests for certain patients of...more

Healthcare & Life Sciences Private Equity Deal Tracker: OrthoSensor Secures $19 Million in Financing

OrthoSensor has announced it has raised $19 million in a private placement of series C preferred stock. OrthoSensor, based in Dania Beach, FL, is a developer of intelligent orthopedic devices and data services....more

Product Liability 2014 Year in Review

In This Issue: - Letter From The Chair - Key Practice Trends + Highlights - Consumer Products - Pharmaceutical Products and Medical Devices - Aviation - Toxics Regulation and Toxic...more

Hospitals struggle with electronic medical records sharing

When Illinois residents seek treatment at a hospital or other facility, they often believe that the technology that is being utilized is improving their safety and health....more

Sharing Clinical Trial Data: A New Era in Life Sciences Has Begun

The European Medicine Agency’s (EMA) Policy on Publication of Clinical Data for Medicinal Products for Human Use (“EMA Policy”)is now effective as of January 1, 2015. Across the Atlantic, the U.S. Institute of Medicine (IOM)...more

Omnicare: Section 11 Liability and Opinions

The Supreme Court defined the circumstances under which liability can be imposed for opinion statements under Securities Act Section 11. Specifically, the Court held that such liability could be imposed on two theories: One...more

Washington Healthcare Update

This Week: Bipartisan, Bicameral Permanent SGR Fix Introduced... House Budget Committee Advances FY2016 Budget Proposal... National Coverage Determinations Proposed for Removal... HHS Releases Proposed Rules on EHR Incentive...more

$12.6 Million Sandoz ASP Reporting Settlement Raises More Questions Than It Answers

Recently, HHS-OIG announced a first-of-its-kind settlement over pharmaceutical manufacturer reporting of Average Sales Price (ASP). Sandoz, Inc. agreed to pay a civil monetary penalty of $12.64 million for alleged failure to...more

Health Alert (Australia) - March 23, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Reports: New South Wales (NSW). Ministry of Health - Media Releases - 18 March 2015 - NSW says protect against mosquitoes after huge...more

Blog: Early 2015 Federal Policy Developments Impacting Medical Technology Companies

Health care is always a major issue in Washington, DC but recently how to promote innovation in medtech has become a priority within that conversation. ...more

Proposed Replacement of Sustainable Growth Rate Addresses Telehealth

On March 19th, Representative Michael C. Burgess, M.D. (R-TX) and Senate Finance Committee Chairman Orrin Hatch (R-UT) unveiled a bipartisan plan to repeal and replace the sustainable growth rate (SGR) physician payment...more

OCR’s Enforcement of HIPAA’s Privacy and Security Rules Continues with Robust 2014

With the news of the recent cyber-attack and resulting data breach at health insurance giant Anthem Inc., the buzz around data security and privacy is again high. The Anthem breach serves as a reminder to those entities...more

RESCHEDULED: 340B in the Spotlight: Congress Offers Webcast of Upcoming Hearing Regarding the 340B Drug Pricing Program

The House Energy & Commerce Health Subcommittee on Health hearing entitled, “Examining the 340B Drug Pricing Program”, originally scheduled for Thursday, March 5th has been RESCHEDULED for March 24, 2015 at 10:00 a.m. EST. ...more

2015 IPO Study

In this Issue: - Executive Summary - 2014 Overview - Year-Over-Year Analysis - Health Care - Technology, Media & Telecommunications - Energy & Power - Financial Services - Industrials -...more

FDA Issues Revised Draft Guidance on Disclosures of Risk Information in Consumer-Friendly Print Advertisements and Promotional...

The U.S. Food and Drug Administration (FDA) recently released its Revised Draft Guidance entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more

Premera Blue Cross Targeted by Hackers – 11 Million Individuals Compromised

Premera Blue Cross (“Premera”) announced this week that it has been the target of a sophisticated cybersecurity attack in which the information of approximately 11 million individuals has been compromised. This announcement...more

2,699 Results
|
View per page
Page: of 108

Follow Health Updates on: