Health Science, Computers & Technology

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HHS OCR Guidance on Ransomware Attacks: They Constitute a “Security Incident” and Are Likely a Data Breach

On July 11, 2016, the HHS Office of Civil Rights (OCR) released guidance on HIPAA covered entities’ responsibilities in a ransomware attack, a type of cyber-attack that has targeted the health care sector extensively in...more

Pennsylvania Enacts Biosimilar Substitution Law

On July 20, Pennsylvania Governor Tom Wolf signed into law Senate Bill 514, which allows pharmacists to substitute for a brand name biological product a less expensive biosimilar product that has been deemed interchangeable...more

Alabama Department of Revenue Now Argues that ALL Software—Canned or Custom—Is Subject to Sales/Use Tax

The Alabama Tax Tribunal (the “Tribunal”) ruled in a recent case that the taxpayer-hospital was entitled to a refund of the sales tax paid on the purchase of software that had been customized for its particular functions...more

Report Warns Providers of HIPAA Violations When Responding to Negative Online Reviews

ProPublica, a public interest investigative newsroom, recently identified more than 3,500 one-star medical reviews on Yelp in which patients complained about privacy issues. ProPublica determined that “in dozens of instances,...more

Protected Health Information: Providers Must Proceed with Caution

Medical records are a powerful weapon in the courtroom. They may reveal the extent of an individual’s injury in a personal injury case or substantiate the severity of an individual’s mental illness when that mental illness is...more

Is encryption the key to your data security?

With the increased rate of data breaches targeting personal information, an increased public awareness of online privacy, and an increasingly demanding regulatory landscape, large and small businesses are looking to...more

Ransomware Attack is a Breach – Unless You Can Prove Otherwise

Ransomware is the fastest growing malware threat in the United States, targeting simple home computers to elaborate corporate IT networks. The Federal Bureau of Investigation recently reported an increase in ransomware...more

OCR Announces First HIPAA Enforcement Action against a Business Associate

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced an agreement with Catholic Health Services of the Archdiocese of Philadelphia (CHCS), settling allegations that CHCS violated the Health...more

FDA Adjustment to Orphan Drug Review May Indicate Increased Scrutiny of Designations

In recent years, applications for orphan drug designations have flooded into FDA at a rapid pace, and this year appears to be no exception. Orphan drug applications received by FDA rose by approximately 30% over the previous...more

Wearable Medical Devices Market Trending Upwards

New reports, such as the Global Diagnostic Wearable Medical Devices Market 2016-2020 Report, bring good news to the rapidly growing wearable medical device market. According to the Report, the diagnostic wearable medical...more

Next-Generation Sequencing: FDA Issues New Guidance for Genetic Tests

On July 6, 2016, the U.S. Food and Drug Administration (“FDA” or “Agency”) released the following two draft guidance documents on the oversight of next-generation sequencing (“NGS”) tests...more

Your daily dose of financial news - The Brief – 7.22.16

EU financial watchdog ESMA has fined rating agency Fitch Ratings Ltd. $1.5 million for reportedly violating the EU’s rules for rating agencies relating to the 12-hour requirement, internal controls, and unauthorized...more

FDA Releases Draft Guidance on Codevelopment of Therapeutic Products and Screening Tests

On July 14, 2016, the U.S. Food and Drug Administration (the “FDA”) released draft guidance on the codevelopment of therapeutic products (such as pharmaceuticals) and companion tests that are used to determine if the...more

Rhode Island’s New Law Requires Health Plans Cover Telemedicine Services

Rhode Island marks the 31st state to enact a telemedicine commercial reimbursement statute. The Telemedicine Coverage Act (HB 7160B) was signed into law by Rhode Island Governor Gina Raimondo on June 28, 2016, representing a...more

Federal Circuit Confirms Post-Licensure Notice of Commercial Marketing Is Mandatory in Biosimilar Litigation

On July 5, 2016, a unanimous Federal Circuit panel held that Apotex failed to give Amgen proper notice of commercial marketing required by the Biologics Price Competition and Innovation Act (“BPCIA” or “Biologics Act”) and...more

AGG Food and Drug Newsletter - July 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

FDA Releases Draft Guidance For Updating Generic Drug Labels

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels. In particular, the draft guidance...more

First Extended-Range Intraocular Lens Receives FDA Approval

The U.S. Food and Drug Administration (FDA) has approved Abbott’s Tecnis Symfony Intraocular Lenses (IOL) for treating cataracts. According to Abbott, the Tecnis Symfony lenses are currently the only lenses in the United...more

Client Alert - The Government Makes a Business Associate Pay: What HIPAA Covered Entities and Business Associates Can Learn from...

The government has entered into its first settlement with a HIPAA business associate, including a $650,000.00 monetary penalty, ushering in a new period of enforcement for third parties who use Protected Health Information...more

Emerging Health IT Issues Important to Businesses

Technology is transforming the delivery of healthcare in the United States, creating exceptional opportunities for innovators and investors. Several successful health IT professionals gathered at Arnall Golden Gregory...more

HHS: Ransomware Attacks Likely HIPAA Breaches In Absence of Encryption

On July 11, 2016, the U.S. Department of Health & Human Services (HHS) issued a Fact Sheet that provides guidance on (i) how HIPAA Security Rule compliance can assist health care organizations combat ransomware attacks, and...more

Is There Coverage for The Pill Mill Lawsuits?

In an effort to deal with the terrible epidemic of drug abuse and the human and economic costs of this dilemma, the state of West Virginia has brought lawsuits in several jurisdictions against pharmaceutical companies and...more

USPTO Joins Cancer Moonshot Effort, Expedites Immunotherapy Patent Applications

On January 12, 2016, President Obama announced a "National Cancer Moonshot" in his State of the Union Address. The Moonshot aims to achieve ten years of progress in cancer research within the next five years. The U.S. Patent...more

Healthcare & Life Sciences Private Equity Deal Tracker: Warburg Pincus to Acquire Stake in Hygenia

Warburg Pincus has announced it will invest in Hygenia. Warburg Pincus, headquartered in New York, is a PE firm that takes a long-term perspective and invest in businesses at all stages of development. It invests...more

Integration of Technology Into Health Care Delivery

The integration of technology into health care delivery is exploding throughout the health industry landscape. Commentators speculating on the implications of the information revolution’s penetration of the health care...more

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