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Class Certification Improper in Data Breach Case, PA Appellate Court Finds

The Pennsylvania Superior Court has affirmed a trial court's decision denying class certification in a data breach case against two health plans, reversing its own earlier ruling in the same case that the plaintiff did not...more

HIPAA Phase 2 Audits: Actions Not Just Words

Action Item: With the commencement of Health Insurance Portability and Accountability Act (“HIPAA”) Phase 2 audits, and the increase in HIPAA enforcement activity, covered entities and business associates need to take HIPAA...more

Facebook, Healthcare Provider Websites and HIPAA

In a class action Complaint filed in the Northern District of California on March 15, 2016, Kiesel Law LLP, on behalf of primary plaintiff Winston Smith and a potential class of others, alleges that Facebook received...more

FDA grants Emergency Use Authorization to Quest Diagnostics for Zika Test

According to Medical Device Daily, the US Food and Drug Administration (FDA) has authorized the emergency use of a diagnostic molecular test developed by Quest Diagnostics subsidiary, Focus Diagnostics Inc., in response to...more

Phase 2 of the OCR HIPAA Audit Program Already Underway

On March 21, 2016, the Department of Health and Human Services, Office for Civil Rights (OCR) announced the launch of the long-awaited Phase 2 HIPAA Audit Program (Phase 2), and OCR activities related to Phase 2 are already...more

Patents-In Suit In ANDA Trial Are Non-Obvious

A 6-day bench trial was held from April 6-14, 2015. After trial, the court entered stipulations and orders regarding infringement of certain claims of the ‘178 and ‘206 patents. The court rejected defendant’s claim that the...more

House Energy & Commerce Committee Approves Legislation to Address Opioid and Drug Abuse Epidemic

The House Energy & Commerce Committee has approved several more bipartisan public health bills, including a series of bills intended to combat opioid abuse and drug addiction. Specifically, the Committee approved...more

New Compounding Policies from FDA May Affect Hospital and Health System Pharmacy Operations

Last month, FDA released three draft guidance documents that are expected to have significant implications for traditional pharmacy-based compounding and the distribution of those drug products....more

Recent Congressional Health Policy Hearings

A number of recent Congressional hearings have focused on health policy topics, including the following: - ..A House Energy and Commerce Subcommittee on Health hearing on “Medicare Access and CHIP Reauthorization Act of...more

FDA Regulatory and Compliance Monthly Recap — April 2016

FDA finalizes guidance on drug design in attempt to reduce medication errors - The finalized guidance revises draft guidance published in 2012 to address public comments calling for clarifications and formatting changes,...more

Failure to Disclose Best Pricing: Pharmaceutical Companies Settle FCA Claims for $784 Million

The Department of Justice announced late last month that pharmaceutical manufacturers Wyeth and Pfizer would pay $784 million to resolve a False Claims Act investigation and qui tam lawsuit arising from Wyeth’s failure to...more

The Writing's on the Wall: Wise Pharma Companies Will Heed FDA Warning in New Draft Guidance on Data Integrity cGMPs

FDA is again shining a spotlight on data integrity violations, announcing in a new draft Guidance for Industry: Data Integrity and Compliance with CGMP that it was “troubl[ed]” by the growing number of such violations that...more

OCR Director Discusses Phase 2 Audits, OCR Priorities

A representative of the U.S. Department of Health and Human Services Office of Civil Rights (OCR) recently presented at a compliance forum to provide comments regarding the roll out of OCR’s Phase 2 HIPAA audits. The...more

The Digital Download - Alston & Bird’s Privacy & Data Security Newsletter – May 2016

Special Focus on “Safe Harbor 2.0,” Privacy Shield and E.U. Data Transfers: Alston & Bird’s privacy team has been closely following the development of Privacy Shield, the proposed successor to the E.U.-U.S. Safe Harbor...more

Supreme Court Denies Petition to Review Expanded Theory of Joint Infringement

On Monday the Supreme Court denied certiorari in Limelight Networks Inc. v. Akamai Technologies Inc. et al, Case No. 15-993. Limelight had petitioned the Court in January, urging for review of the Federal Circuit’s en banc...more

Hello Insurers – Court says CGL may Cover Privacy Breaches Occurring Prior to 2014

In April 2013, Glens Falls Hospital admitted that the medical records for more than 2,300 of its patients were stored for several months on an unprotected computer server. The hospital’s outside records contractor, Portal...more

Washington, D.C. Update – April 2016

FY17 Appropriations - The House and Senate Appropriations Committees continue to move forward on individual FY17 spending measures based on discretionary spending levels enshrined in last fall's bipartisan budget deal....more

President Obama Signs Zika Priority Review, Controlled Substances Laws

President Obama has signed into law S. 2512, which adds Zika virus to the Food and Drug Administration priority review voucher program to encourage the development of treatments for neglected tropical diseases. In addition,...more

Raleigh Orthopedic Clinic settles with OCR for $750,000 for lack of business associate agreement

Consistent with the settlement the OCR agreed to with North Memorial Health Care of Minnesota, the Office for Civil Rights has settled its investigation of Raleigh Orthopaedic Clinic, P.A. (Raleigh Orthopaedic) for $750,000....more

CMS Publishes Proposed Rule Implementing MACRA Physician Payment Model

On April 27, 2016, the Centers for Medicare & Medicaid Services (CMS) posted a pre-publication version of a proposed rule implementing changes to Medicare payment for physician services authorized under the bipartisan...more

New Part B Drug Payment Model Proposed

On March 11, 2016, CMS proposed implementation of a new two-phase model for drugs reimbursed under Part B of the Medicare Program (“the Proposed Model”). Drugs reimbursed under Part B include drugs administered in hospital...more

FDA Issues Three Draft Guidance Documents For Drug Compounders

On April 15, 2016, the U.S. Food and Drug Administration (“FDA”) issued three new draft guidance documents related to human drug compounding under the Food, Drug, and Cosmetic Act (“FD&C Act”), as amended by Title I of the...more

As drug prices skyrocket, senators rip an ex-Big Pharma CEO

Prescription drug prices continue to soar, prompting hearings on Capitol Hill, and leading a columnist to suggest nifty ways how Big Pharma could better educate consumers about medications, especially since many seniors may...more

Abbott to Acquire St. Jude Medical for $25 Billion

A burst of potential acquisitions and consolidations occurred on April 28th in the medical device world, the largest being Abbott Laboratories‘ deal to acquire St. Jude Medical Inc. The deal is for $25 billion dollars and...more

FTC Settles Monopolization Charges Stemming from Contract Exclusivity Terms Used by First-to-Market Medical Polymer Maker

The mere possession of monopoly power does not violate federal antitrust laws. The laws only address the anticompetitive acquisition, maintenance, or abuse of that power. The Federal Trade Commission (“FTC”) entered into a...more

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