Health Science, Computers & Technology

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OCR announces launch of Phase 2 of HIPAA audits

Although the Office for Civil Rights (OCR) has indicated in the past that it would start its next round of HIPAA audits, apparently it means business now. In the wake of an Inspector General report that the OCR was merely...more

Comment period extended for NIST Cybersecurity Practice Guide

The National Institute of Standards and Technology has announced that due to stakeholder feed-back, the period to submit comments for the draft guide, “Securing Electronic Health Records on Mobile Devices” has been extended...more

New registration rules and calculation methodology for maximum manufacturer's sale prices for vital and essential drugs

On October 1, 2015, the new versions of the following regulations will come into legal force and effect: - The Rules for the state registration and re-registration of maximum sale prices set by pharmaceutical...more

FDA Detects That a Screening Tool for Early Detection of Cancer Types Might Require More Sleuthing

The Food and Drug Administration recently issued an untitled letter to a medical device company concerning its non-invasive blood test intended for use as a screening tool for the early detection of certain cancer types. FDA...more

Blog: HHS To Launch New HIPAA Audits in Early 2016 in Response to OIG Reports

The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) issued two reports yesterday calling for the HHS Office of Civil Rights (OCR) to strengthen its Health Insurance Portability and...more

A&B Healthcare Week In Review, September 2015

On September 25, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Medicare Program: Medicare Clinical Diagnostic Laboratory Tests Payment System”. This proposed rule would...more

Highlights from the Tenth CEO/Innovators Roundtable: June 4 – 5, 2015

This past June, leaders from health systems, outpatient services companies, health insurers, IT and equipment suppliers, health retailers, home care providers, pharmaceutical companies, and investors gathered in Chicago for...more

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

CMS Publishes Long-Awaited PAMA Proposed Rule

On September 25, 2015, the Centers for Medicare & Medicaid Services (CMS) announced publication of the proposed rule (the “Proposed Rule”) implementing substantial changes to the Medicare Clinical Laboratory Fee Schedule...more

CMS Proposes Overhaul of Clinical Lab Payment Methodology: What You Need To Know

On Friday, the Centers for Medicare & Medicaid Services (“CMS”) issued a long-awaited proposed rule that would drastically change the payment rates for clinical laboratory services beginning January 1, 2017 (the “Proposed...more

HHS Issues Proposed 340B Program Omnibus Guidance: Five Things to Watch

The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

FDA Establishes Patient Engagement Advisory Committee

The FDA recently announced establishment of the Patient Engagement Advisory Committee (PEAC). According to a notice published by the FDA, the PEAC will advise the Commissioner of the FDA, presently Dr. Stephen Ostroff, M.D.,...more

Blog: Joining the Debate, Hillary Clinton Releases Plan to Curb Drug Prices

In the wake of the uproar about drug pricing, Hillary Clinton unveiled on Tuesday, a plan to address the rising cost of prescription drugs. The plan will focus on ending “excessive” profits, lowering out-of-pocket costs,...more

Health Alert (Australia) - September 28, 2015

In This Issue: -Judgments; Legislation; and Reports In This Issue: -Judgments; Legislation; and Reports Australia Federal Court Alphapharm Pty Ltd v H Lundbeck A/S [2015] FCAFC...more

No X-Ray Vision at the FTC: Court Hands Agency a Rare Defeat in the Steris/Synergy Merger

In FTC v. Steris, the FTC was handed a rare litigation defeat. The case was notable because it involved a merger between companies who were not current competitors. The FTC alleged that without the merger, Synergy would have...more

TransEnterix Acquires ALF-X for $99.8 Million

Research Triangle Park, North Carolina-based TransEnterix, Inc. announced today that it has acquired the surgical robotics division of SOFAR S.p.A., an Italian health care company. According to the announcement, the deal is a...more

Don’t Flush the Drugs! The EPA is Coming!

The Environmental Protection Agency (EPA) recently issued a pre-publication Proposed Rule (40 C.F.R. part 266, subpart P) regulating the management and disposal of drugs deemed “hazardous waste pharmaceuticals” by healthcare...more

It’s About Time! 10 Key (Needed) Changes Proposed to the Human Subjects Protection “Common Rule”

The world has changed drastically since 1991 when Operation Desert Storm was underway; the USSR crumbled; Prince Charles and Princess Diana separated; the World Wide Web was born; gas cost $1.14; and the Dow peaked at 3168....more

Evolving Litigation of Data Breach Claims

An Illinois circuit court judge has dismissed five of six claims in a consolidated class action against Advocate Health and Hospital Corporation arising from a data breach in July 2013. The judge’s dismissal with prejudice...more

Excellus Blue Cross Blue Shield sued for data breach announced last week

Within days of Excellus Blue Cross Blue Shields’ (Excellus) announcement that its data had been accessed by a hacker through a “sophisticated” cyber-attack, two law firms teamed up to file a proposed class action suit last...more

Lions and Tigers and Bears, Oh My! The Unexpected Laws that May Affect Your Telehealth Business

An increasing number of health care providers are exploring telemedicine, either as an adjunct to their primary physical practice or as a separate and new venture. Providers have determined that many aspects of the service...more

Cantel Acquires Medical Innovations for $79.5 Million

Cantel Medical Corp. has acquired medical device business Medical Innovations Group Holdings Ltd. for $79.5 million, according to press releases. According to its website, Cantel Medical is a global company dedicated to...more

Pharma and Medical Device Industry Victory in Off-Label Marketing Decision

The U.S. District Court for the Southern District of New York recently held that the FDA may not constitutionally bring a misbranding action based on truthful and non-misleading off-label promotion of an FDA-approved drug,...more

Fitbit Agrees to Sign Business Associate Agreements and Take on HIPAA Compliance

Is your Fitbit data covered by HIPAA? It depends upon where you got it (kind of). If you go to the store and pick up a Fitbit on your own, the data it generates is governed by the user agreement that you click through...more

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