Health Science, Computers & Technology

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Approval of Sandoz’s Pegfilgrastim Biosimilar May Be Delayed until at Least 2018

As we previously reported, in July the FDA issued a complete response rejecting Sandoz’s aBLA for a biosimilar of Neulasta® (pegfilgrastim). Novartis, Sandoz’s parent, indicated that that Sandoz was “working with the agency...more

Recent CyberSecurity Incidents Emphasize Importance of Cyberinsurance

As the threat of cyberattacks continues to pose daily threats to businesses large and small, more companies have turned to cyber insurance products to shore up protection against these disruptive threats. A spate of recent...more

Texas Medical Board Drops its Fifth Circuit Appeal To Bar Antitrust Challenge

On October 17, 2016, the U.S. Court of Appeals for the Fifth Circuit granted the Texas Medical Board’s (“Board”) motion to voluntarily dismiss its appeal of the District Court’s decision on sovereign immunity in its latest...more

FDA & CMS Extend Medical Device Parallel Review Program

The Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have announced that they are making permanent their “Program for Parallel Review of Medical Devices,” which is now operating as a...more

HHS Issues Final Rule that Expands the Requirements for Disclosure of Clinical Trial Data to

On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more

OCR Explains How Information Blocking Violates HIPAA

The US Department of Health and Human Services Office for Civil Rights recently posted guidance clarifying that a business associate such as an information technology vendor generally may not block or terminate access by a...more

HHS Publishes New Guidance on HIPAA and Cloud Computing

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) has issued a new guidance regarding HIPAA compliance and the use of cloud computing solutions. The guidance is intended to assist covered entities...more

DOJ/FTC Joint Guidance for Human Resources Professionals Suggests Broad Antitrust Risks

Provisions restricting the hiring of another company’s employees are often included in vendor agreements and a variety of corporate transactions and licenses. And it’s not unusual to see similar constraints adopted in...more

Genomics and FDA Regulation: A Work in Progress

It took over a decade to sequence the human genome the first time, at a cost between half a billion and a billion dollars. Now, however? An entire human genome can be sequenced for one or two thousand dollars, in a matter of...more

FDA Launches New Webpage to Report Regulatory Misconduct

Earlier this week, the FDA launched a new webpage to simplify the process of reporting violations of the law by medical device manufacturers and individuals marketing medical devices. Unlike the MedWatch system for reporting...more

FDA to Issue Draft Guidance on Interchangeability by End of Year

Last Thursday, October 20, the FDA held a scheduled public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA). The FDA heard from a wide spectrum of stakeholders, including patient/public health advocates,...more

HHS Issues Guidance Regarding Importance of Business Associate Agreements Between Covered Entities and Cloud Services Vendors

The Health and Human Services Office for Civil Rights (OCR) recently issued guidance regarding the importance of covered entities and cloud service vendors maintaining business associate agreements (BAAs) where electronic...more

Price fixing not justified to protect pharmacies in rural areas

On 19 October 2016, the Court of Justice of the European Union (CJEU) issued an important judgment concerning the German law on fixing prices of retail prescription drugs. In the case before the Higher Regional Court of...more

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

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