Health Science, Computers & Technology

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HHS Finalizes Overhaul of Federal Human Subjects Research Protections

In Depth - On January 18, 2017, the Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule overhauling the federal human subjects research regulations known as the “Common Rule.”...more

FTC and States Reach $100 Million Antitrust Settlement with Mallinckrodt

On January 18, 2017, the Federal Trade Commission (“FTC”) announced that it reached a $100 million settlement with pharmaceutical company Questcor Pharmaartinceuticals, Inc. and its Irish parent company, Mallinckrodt plc. ...more

What Is The Trump Pharmaceutical Policy?

Pharmaceutical stocks took a hit after President-elect Trump criticized the industry during his January 11, 2017 press conference. But he also expressed support for the domestic pharmaceutical industry. What is the Trump...more

Vendor Causes Breach of Over 5,000 Patient Records

The continued risk that vendors pose to companies, including health care entities cannot be overemphasized. This week, Sentara Healthcare (Sentara) announced that one of its third-party vendors was the victim of a...more

Longitudinal Study Finds that Post-Concussion Syndrome (PCS) May Be Permanent

University of Toronto researchers have just published an important longitudinal study following patients with Post-Concussion Syndrome (PCS) based on a diagnosis of concussion in conformity with the international sport...more

REDIAL: 2016 TCPA Year In Review – Analysis of Critical Issues and Trends

The Sutherland TCPA team has published its third annual REDIAL: 2016 TCPA YEAR IN REVIEW – ANALYSIS OF CRITICAL ISSUES AND TRENDS. This publication reflects our in-depth analysis of significant Telephone Consumer...more

FDA takes a half-step toward acknowledging manufacturers' right to disseminate truthful, non-misleading off-label information

The FDA has issued significant new Draft Guidance on January 17, 2017 that touches on the hot-button issues surrounding manufacturer dissemination of off-label information about approved drugs and medical devices, titled...more

Obama FDA’s Parting Shot On Off-Label Promotion And The First Amendment

We haven’t digested it yet, so this isn’t a substantive post, but we wanted to make our readers aware that today the FDA made an announcement, which states in pertinent part...more

Summary of FDA Guidance on the Nonproprietary Naming of Biological Products

On January 12, 2017, the U.S. Food and Drug Administration (“FDA”) released a final Guidance for Industry, Nonproprietary Naming of Biological Products, as part of the Agency’s ongoing efforts to implement the Biologics Price...more

The Anthem Breach – A Retrospective

Many people and news outlets have opined, weighed in, and informed the public about the 2015 Anthem breach. It is still a hot topic in January 2017, because it currently lines up with other hot stories about hacking ordered...more

What's in a Name? A Four-Letter Suffix to Be FDA Compliant

The BPCIA and the Debate Over Naming Biosimilars - Most drugs on the market today are small-molecule compounds with active pharmaceutical ingredients that can be duplicated to create “generic” drugs. It is impossible,...more

“Rest Until Symptom Recovery” May Not be the Best Medicine for Children and Adolescents Recovering from Acute Concussion

In a study published in the Journal of the American Medical Association (JAMA) on December 20, 2016, Canadian researchers found that children and adolescents who returned to exercise within seven days of experiencing a...more

Florida Board of Medicine Hearing on Telemedicine and Medical Marijuana

The Florida Board of Medicine will hold a public hearing on February 3, 2017 to discuss its proposed amendment to Florida’s telemedicine practice rules. The proposed amendment, published December 8, 2016, is intended to...more

HRSA Announces Final Rule on Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

A new regulation issued by the Health Resources and Services Administration (“HRSA”) sets forth a process by which civil monetary penalties may be imposed on drug manufacturers that knowingly and intentionally charge 340B...more

FDA Issued Draft Guidance on Interchangeability

Today, the FDA announced the availability of a draft guidance on biosimilar interchangeability, entitled “Considerations in Demonstrating Interchangeability With a Reference Product,” which is currently available on FDA’s...more

What You Need To Know About the FDA’s Guidance on Postmarket Cybersecurity

The FDA released its final Guidance on Postmarket Management of Cybersecurity in Medical Devices during the week between Christmas and New Year. You can link to a full copy here, and we gave you our detailed take on the draft...more

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

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