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FDA Denies AbbVie’s Citizen Petition on Interchangeability

FDA has denied AbbVie’s Citizen Petition on interchangeability. Back in December 2015, AbbVie submitted a Citizen Petition to FDA requesting that the agency take certain actions regarding interchangeability standards for...more

Potential Repeal of Medical Device Tax

With the upcoming Republican-dominated Presidency and Congress in 2017, the Affordable Care Act, or at least parts of it, look to be on the chopping block. One of the changes that may be forthcoming is a repeal of the 2.3%...more

FDA Releases Biosimilar Guidance for Industry

On December 29, 2016, the FDA issued guidance to assist applicants seeking FDA approval of a proposed biosimilar product under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). To obtain such approval, an...more

Antisense Oligonucleotide SPINRAZA Wins FDA Approval

On December 23, 2016, the U.S. Food and Drug Administration approved SPINRAZA™ (nusinersen), an antisense oligonucleotide directed to survival motor neuron-2 (SMN2) transcripts for the treatment of spinal muscular atrophy...more

U.S. Military Special Operations Command Workers’ Data Exposed by Vendor

Military personnel continue to be victimized by data breaches. This time, the personal information of healthcare workers employed by Potomac Healthcare Solutions (Potomac), who work for a U.S. Special Operations Command were...more

Patient Records Requests: What You Need to Know [Video]

Our guest on Healthcare Matters is Richard J. Rymond, an attorney at Reminger Co., LPA, who specializes in in medical, dental and other forms of professional, commercial and general liability. He is the Dental Liability...more

Time Waits for No One: OCR Announces First HIPAA Settlement for Lack of Timely Breach Notification

On Jan. 9, 2017, the Department of Health and Human Services Office for Civil Rights (“OCR”) announced the first HIPAA enforcement action for failure to timely report a breach. Often investigating and making formal...more

New Hampshire Psychiatric Hospital Patient Records Posted Online by Former Patient

The New Hampshire Department of Health and Human Services has notified up to 15,000 patients of its psychiatric hospital (New Hampshire Hospital) that their names, addresses, Social Security numbers, Medicaid ID numbers and...more

News from Abroad: Summary Report on the Final Guidance from the English Court of Appeal on Second Medical Use Patents

The final decision of the Court of Appeal in the Lyrica® litigation was handed down on 13 October 2016. This litigation, relating to the painkiller pregabalin marketed by Warner-Lambert for the treatment of pain under the...more

Eighth Circuit Rules That ERISA Expressly Preempts Iowa Pharmacy Benefit Law

The United States Court of Appeals for the Eighth Circuit recently held that ERISA expressly preempts an Iowa law that imposes onerous regulatory requirements on pharmaceutical benefit managers operating in Iowa. The reversal...more

Failure to Timely Notify Results in Enforcement Action and Significant Settlement

For the first time, on January 9, 2017, the Department of Health and Human Services, Office for Civil Rights (HHS/OCR) settled a HIPAA enforcement action based on the untimely reporting of a breach of unsecured protected...more

Grassley Continues To Press CMS on Medicaid Drug Rebate Classifications: What Will Be the Fallout?

Back in early October, we were all transfixed by the announced Mylan settlement with the U.S. Department of Justice (DOJ) over Mylan’s alleged underpayments of Medicaid Drug Rebates for the EpiPen. Although Mylan indicated...more

FDA Releases Biosimilar Naming Guidance

FDA just released a final Guidance for Industry, “Nonproprietary Naming of Biological Products.” The guidance provides that naming for originator biological products, related biological products, and biosimilars should...more

OIG Issues Favorable Advisory Opinion for Cost-Sharing Waiver and Stipend Arrangements in a Government-Funded Clinical Research...

The Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a university health system (Requestor) regarding two arrangements: (1) a proposal to waive cost-sharing obligations of...more

Breach of Privacy Prompts Breach of Etiquette: DHHS Sets New Precedent in Privacy Breach Enforcement

On January 9, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) took action against a health system for non-timely reporting of a breach of protected health information. It was the first...more

"OFAC Eases Restrictions on the Export of Medical Devices to Iran"

On December 22, 2016, the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) announced amendments to the general license (GL) that authorizes the export or re-export of certain medical devices to Iran....more

Final Rules Released Covering 340B Ceiling Prices and Manufacturer Penalties

The US Department of Health and Human Services and the Health Resources and Services Administration recently issued final rules related to the 340B Drug Pricing Program that impose fines on drug manufacturers that overcharge...more

Joint Commission Confirms Ban on Texting of Patient Care Orders

After briefly considering a reversal of its prohibition on texting orders, The Joint Commission (TJC), in consultation with the Centers for Medicare & Medicaid Services (CMS), announced last month that its ban would continue...more

Guest Post – MDL Court: Preemption Leaves No “Glimmer of Hope” for Labeling Claims Against a Pharmacy

What follows is a post authored by Jaclyn Setili, a Reed Smith associate. She is discussing what we believe is the first extension of Mensing/Bartlett preemption to claims involving pharmacies – something we’ve previously...more

Top 5 Patent Red Flags in Life Sciences Due Diligence

Since IP represents 75 to 90% of the value of life science transactions, due diligence is a critical component of the valuation process....more

Beyond the Eleventh Hour: FDA Prepares to Finalize Intended Use Amendments Despite Midnight Rule Relief Act

On Monday, FDA issued a final rule to amend FDA’s established definitions of “intended use” for drugs and devices, the primary consideration in determining whether a product is regulated for a particular use and what...more

EEOC issues guidance on new wellness notice mandated for 2017

Effective as of the first day of the plan year that began on January 1, 2017, or after, employers maintaining wellness programs that collect employee health information must satisfy a new notice requirement. The EEOC has...more

FDA Accepts aBLA for Mylan-Biocon’s Proposed Herceptin® Biosimilar

As we previously reported, in November Mylan and Biocon submitted an aBLA to the FDA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). Today, Mylan announced that the FDA has accepted its...more

2017 Health Information Privacy and Security New Year’s Resolutions

To start off the New Year, here are some potential health information privacy and security resolutions. You can use these Annual, Quarterly, and Monthly lists to map out your privacy and security tasks for the year, and then...more

Three-Month Delay Means Health Network Must Pay

A delay in reporting a HIPAA violation can result in a significant monetary penalty. That was the message sent by the Office for Civil Rights (OCR), which recently announced the first HIPAA settlement based on the untimely...more

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