Navigating Data Privacy and Security in Telemedicine's Uncharted Territory
Insurance Limits and Case Value - A Clear Correlation?
Polsinelli Podcast - What Employers Need to Know About Dealing With Cash
Medical PL Risks in Retail Healthcare
Physician Considerations When Prescribing Medical Marijuana
Do I need an expert witness in my case?
Electronic Medical Records: Help or Hindrance?
How Does King v. Burwell Decision Affect the Affordable Care Act?
Antitrust Law Issues for Health Care Providers
Variables Affecting Medical PL Settlement Values
Polsinelli Podcast - Is a Single U.S. Food Agency a Reality?
The Biggest Obstacle to Value-Based Care
Technology in Healthcare
Do healthcare professionals have to report legal trouble to their licensing board?
Health Care Enforcement: The Impact on Private Equity Investments
Polsinelli Podcasts: Cloud Computing, From Cybersecurity to Confidentiality Issues
Polsinelli Podcast - Pharmacy Compounding: What's Next in Regulation?
Polsinelli Podcasts - The Latest on a Shift in Regulation in Dietary Supplements
PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA
A Moment of Simple Justice - Vaccines
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
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
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
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
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
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
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
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
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
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
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
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
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
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
In This Issue:
-Judgments; Legislation; and Reports
In This Issue:
-Judgments; Legislation; and Reports
Alphapharm Pty Ltd v H Lundbeck A/S  FCAFC...more
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
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
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
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
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
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
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 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
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
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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