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Health Science, Computers & Technology

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

Health Update - April 2017

CMS Issues Self-Referral Disclosure Protocol for Stark Law Violations - On March 28, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a new voluntary self-referral disclosure protocol (SRDP) for disclosing...more

How Will the Trump Administration Impact Healthcare Litigation?

Editor's Note: In a dramatic conclusion to the heated debate surrounding the American Health Care Act (AHCA), the bill was withdrawn after it became clear that House leadership did not have enough votes to pass it. There is...more

Sandoz’s Biosimilars Rituximab and Etanercept are Recommended for Approval in Europe

by Goodwin on

On Friday, April 21, 2017, Sandoz announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sandoz’s biosimilars rituximab and etanercept in Europe. If approved, rituximab may be...more

.Health: What You Need to Know About the Internet’s Newest Domain Name

by Carlton Fields on

On May 8, the new .health Internet top-level domain opens up to members of the health care industry and will be awarded on a “first-come, first-served” basis. Below is what your organization needs to know about “.health.”...more

Health Care E-Note - April 2017

by Burr & Forman on

An often overlooked and under publicized provision of the False Claims Act (“FCA”) is the retaliatory discharge prohibition. This is probably because retaliatory discharge claims do not grab headlines by winning multimillion...more

Failure to Implement Business Associate Agreement Results in $31,000 Settlement For Health Care Provider

by Saul Ewing LLP on

On April 20, 2017, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that Children’s Digestive Health (CDH) agreed to pay HHS $31,000 for its failure to have a business associate...more

An Opportunity to Shape Compliance with GDPR

by Hogan Lovells on

A close observer of the GDPR will have noticed that, in several places, individual EU Member States can implement derogations from the GDPR requirements. Of course, as a regulation under EU law there is less scope for local...more

HIPAA and the Cloud’s Shared Responsibility Models

by Snell & Wilmer on

Cloud-based service providers (CSPs), like Amazon Web Services and Microsoft Azure, offer online access to shared computing resources. As such, they have developed a “shared responsibility model” for how CSPs and companies...more

St. Jude Medical On Hot Seat for Cybersecurity Flaws in Home Monitoring System

The Food and Drug Administration (FDA) recently issued a warning letter to St. Jude Medical, alleging that it failed to properly investigate issues with the batteries in its defibrillator implants and for failing to fix the...more

Smoke Screens & Side Shows

by Reed Smith on

We confess, we can’t think of any good reason for admitting evidence concerning product risks that the plaintiff in a particular case never actually encountered – yet plaintiffs try it with a straight face all the time. It’s...more

Legislative Update: State Biosimilar Substitution Laws

by Goodwin on

More states continue to enact laws regarding the substitution of biosimilars for prescribed biological products. We have previously reported on the enactment of such laws in New Jersey, Arizona, Missouri, Oregon and...more

Proving Utility, Demonstrating Value: How to Align the Moving Parts in Personalized Medicine Reimbursement

by Foley & Lardner LLP on

Of the many business, operational, legal, regulatory and clinical obstacles standing in the way of widespread delivery of personalized medicine, the single greatest challenge may lie in solving the reimbursement puzzle....more

FDA Approval of 23andMe Genomic Test Shows the Way for Direct-to-Consumer Diagnostics

On April 6, 2017 the FDA Center for Devices and Radiological Health formally approved 23andMe’s Personal Genome Services Test as a Class II Medical Device. Approved tests include assessment of an individual’s genetic risk of...more

What Does the Cures Act Really Mean for Patients?

When signed by President Obama last December, the 21st Century Cures Act—which was the culmination of seven revisions written after the House of Representatives first introduced it in January 2015—was applauded by some as a...more

Forget Bigger Data – Personalized Medicine Needs Smarter Data to Reach its Full Potential

by Foley & Lardner LLP on

The advent of big data has helped enable the growth of personalized medicine. But if machine learning and analytics are to truly help transform health care, it won’t be through bigger data, but through harmonized, smarter...more

Appeal for Legislative Action to Address REMS Concerns

by Goodwin on

Last month, during the Biosimilar and Generics User Fee Acts (BsUFA II and GDUFA II) reauthorization hearing, a subject of considerable discussion was Risk Evaluation and Mitigation Strategies (REMS). REMS is a provision...more

Small Healthcare Provider Pays $31,000 for Failing to Have a Business Associate Agreement With File Storage Vendor

by Jackson Lewis P.C. on

Disclosing protected health information (PHI) to a business associate without a compliant business associate agreement (BAA) is an improper disclosure under the HIPAA privacy and security regulations. According to the HHS...more

New State Substitution Laws, and a Busy Spring for Biosimilars

We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico....more

Deeper Dive: Frequency and Severity

by BakerHostetler on

All industries are affected by cyberattacks, but how often and to what extent they occur vary greatly by industry type. As for frequency, the healthcare industry in 2016, for the third year in a row, saw the greatest...more

FDA Relents, Grants Premarket Authorization to 23andMe Genetic Diagnostics Test

On April 6th, the U.S. Food and Drug Administration (FDA) continued to loosen the reins on the genetic diagnostic and DNA analysis company 23andMe with regarding to direct-to-consumer (DTC) genetic testing related to...more

WDNY Holds that Tysabri Warnings are Adequate as Matter of Law and that Product Liability Claims are Preempted

by Reed Smith on

However a drug/device product liability is styled, it will almost always be focused on a claim of failure to warn. Why do plaintiffs insist on inserting a cause of action for manufacturing liability when there is not a whiff...more

OCR Levies Hefty Fine Against FQHC

Showing no signs of letting up on enforcement actions, the Office for Civil Rights (OCR) late last week settled an investigation against Metro Community Provider Network MCPN, a Colorado based federally qualified health...more

March Sees an Uptick in Health Data Breaches

The monthly breach report issued by Protenus last week outlining data breaches that occurred in the month of March concludes that there was an “uptick in the number of health data breach incidents.”...more

Congressional Leaders Seek Input in UFA Reauthorization Draft Bill by April 28, 2017

On April 14, 2017, leaders from the Senate HELP Committee and the House Energy & Commerce Committee released the first discussion draft of the 2017 FDA user fee reauthorization bill. As we’ve been reporting, these two...more

Generic consistency evaluation in China: the coming paradigm shift in drug pricing and patent cliff

by Allen & Overy LLP on

China is one of the largest generic drug markets in the world. As part of the drug approval reform, the ongoing generic consistency evaluation (GCE) is likely to have significant, long-lasting impacts on the market landscape,...more

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