Health Science, Computers & Technology

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Catalent Biosimilars Manufacturing Update

Yesterday, Catalent Pharma Solutions announced that it has broken ground for a 22,000 square foot extension of its biologics manufacturing facility in Madison, Wisconsin. According to the press release, following completion...more

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

ICU Medical Buys Hospira Infusion Systems From Pfizer

ICU Medical and Pfizer have reached an agreement to transfer ownership of Hospira Infusion Systems to ICU Medical, according to a joint press release on October 6....more

Health Care System’s HIPAA Security Risk Results in $2.14 Million Fine

On October 18, 2016, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), announced that St. Joseph Health (SJH) agreed to settle allegations relating to the HIPAA Privacy and Security Rules,...more

MHRA Updates Guidance on Healthcare Apps as Medical Devices

Healthcare apps are becoming a greater part of everyday life. The increasing prominence and functionality of these apps has lead to the question of when healthcare apps should be regulated as medical devices. In the United...more

Clouds, With A Nearly 100% Chance of a Business Associate Agreement

HHS recently posted guidance on its website addressing HIPAA’s approach to cloud computing. Basically, any time a cloud service provider has electronic protected health information (ePHI), it’s a business associate. This is...more

Medical Device Updates: U.S. Food and Drug Administration (FDA) Releases Numerous and Important Draft Guidance Documents

The summer of 2016 saw a flood of new medical device-related guidance documents coming out of FDA’s Center for Devices and Radiological Health (CDRH). Some of these draft guidance documents, such as those addressing device...more

Federal Court Finds That 2015 TCPA Safe Harbor Applies to Automated Flu Shot Reminders

A recent decision from a federal court in California found that a retail pharmacy’s “flu shot reminder” calls to mobile phones fall within the FCC’s TCPA safe harbor for exigent health care treatment messages. But the holding...more

Member States cannot impose uniform retail prices for prescription-only medicinal products, highest EU Court says

EU law precludes national legislation setting fixed retail prices for prescription medicinal products, as it unreasonably restricts imports - On 19 October 2016, the European Court of Justice issued a ruling concluding...more

Sharing Consumer Health Information? Look to HIPAA and the FTC Act

Does your business collect and share consumer health information? Check out these tips from the FTC for complying with HIPAA and the FTC Act....more

New Report Outlines 5 Year Plan to Achieve Cancer Moonshot

The Cancer Moonshot Task Force has just released its 5 year plan for implementing President Obama’s “Cancer Moonshot” program (“Report”). The initiative, announced during President Obama’s 2016 State of the Union Address, is...more

Upcoming FDA Public Meeting on Speech and Medical Products

As a reminder, the Food and Drug Administration (FDA) is holding a two-day public meeting on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” ...more

St. Joseph Health Settles with OCR for $2.14 Million

The Office for Civil Rights (OCR) has announced that it has entered into a settlement with St. Joseph Health, which operates hospitals and nursing homes in California, Texas and New Mexico, for $2.14 million for alleged HIPAA...more

Employment Law This Week®: ACA Section 1557 Notice Requirements, Retaliation Under the ACA, Big Data Analytics, Sexual Orientation... [Video]

We invite you to view Employment Law This Week® - a weekly rundown of the latest news in the field, brought to you by Epstein Becker Green. We look at the latest trends, important court decisions, and new developments that...more

HHS-OCR Announces Guidance On HIPAA Compliance And Cloud Computing

On October 6, 2016, the Department of Health and Human Services Office for Civil Rights (“OCR”) issued guidance on complying with HIPAA privacy, security, and breach notification rules when using cloud computing technology...more

Health Update - October 2016

Defining and Resolving the Provider Data Dilemma - Editor’s Note: Provider data drives the most fundamental processes in the healthcare system. Inaccurate provider data puts patient care and billions of dollars at risk....more

Warning Causation Potpourri in New Jersey Mass Tort

Over the last couple of years, the Accutane mass tort in New Jersey state court has become the gift that keeps on giving. The latest installment is a two-fer: In re Accutane Litigation, 2016 WL 5958374 (New Jersey Super....more

Failure Under the HIPAA Security Rule Costs $2.14 Million

On October 18, 2016, the Department of Health and Human Services, Office of Civil Rights (“OCR”) announced a $2.14 million settlement with St. Joseph Health (“St. Joseph”), a non-profit integrated Catholic healthcare delivery...more

Johnson and Johnson Insulin Pump Potentially Vulnerable to Cyber Attack

Johnson & Johnson recently warned its customers of a cybcersecurity issue with one of its insulin pumps, potentially leaving thousands of users vulnerable.  According to Johnson & Johnson’s letter, “a cybersecurity issue with...more

3D Printing Quarterly Report: Q3 - 2016

Study offers plan to make Northeast Ohio region the Silicon Valley of 3D printing - A report from the Youngstown Business Incubator and America Makes in Youngstown and Team NEO and Magnet in Cleveland offers a plan to...more

HHS Publishes Guidance on HIPAA and Cloud Computing

On October 7, 2016, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) published guidance to assist cloud service providers (CSPs) and their customers with HIPAA compliance. As discussed below,...more

European Health Care Compliance Challenges (And Solutions)

Life sciences and health care companies (“health care companies”) rightly invest a significant amount of time and money into ensuring compliance with health care regulations in the countries in which they are based, but...more

First FDA Approval of Closed-Loop Insulin Pump

Medtronic’s MiniMed 670G system was recently approved by the FDA – this marks the first-ever FDA approval of a hybrid closed-loop insulin delivery system. Medtronic explains that the system uses a computer algorithm in...more

Three Dozen States Sue Makers of Opioid Addiction Treatment Medications for Antitrust

With opioid abuse continuing to dominate national headlines, manufacturers of opioid overdose medications are facing intense scrutiny over pricing practices that threaten (or those perceived as threatening) public...more

U.S. Department of Education Issues Guidance on Student Medical Records

On September 14, 2016, the Department of Education (DOE) issued a “Dear Colleague Letter” to provide guidance on the application of the Family Educational Rights and Privacy Act (FERPA) to the disclosure of student medical...more

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