Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Jones Day ordered by Published Date Descending.
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A Dramatic Shift In Health Care Pricing Transparency
The proposed rules apply to all hospitals, regardless of whether they receive federal funding.
United States
13 Sep 2019
D.C. Circuit Rejects Novel Theory Of Reverse False Claims Liability For Reporting Violations
The prospect of a substantial bounty often motivates enterprising relators to assert novel theories of recovery under the FCA—including, increasingly, under the FCA's reverse false claims provision, ...
United States
24 Jul 2019
Eighth Circuit Upholds Injunction Against Physician Group Acquisition
Sanford is a vertically integrated healthcare system operating in eight states, including North Dakota.
United States
9 Jul 2019
HHS Releases Guidance On Direct Liability For Business Associates Under HIPAA
On May 24, 2019, the Department of Health and Human Services issued a new fact sheet clarifying business associates' direct liability for violations of the Health Insurance Portability and Accountability Act.
United States
21 Jun 2019
Lead Compound Analysis Not Applicable To Certain Method-Of-Treatment Claims
The Federal Circuit distinguished method-of-treatment claims from compound claims to which the lead compound analysis applies.
United States
10 Jun 2019
Confidential FDA Communications As Prior Art In Hatch-Waxman Litigation
In a Hatch-Waxman litigation, the claims recite oxymorphone with less than 0.001% of an impurity called 14-hydroxymorphinone.
United States
31 May 2019
Supreme Court Sides With Merck In Unanimous Fosamax® Product-Liability Decision
Pharmaceutical company Merck recently obtained a unanimous win before the Supreme Court in a product-liability matter involving Merck's prescription medicine Fosamax®.
United States
29 May 2019
Federal Circuit Asserts Jurisdiction To Review ITC's Non-Institution Decision
In a long-awaited decision, a split panel of the Federal Circuit confirmed on May 1, 2019, that the Court has jurisdiction to review the ITC's decision not to institute an investigation.
United States
8 May 2019
A Game Changer For Financial Investors In The German Health Care Sector
On March 14, 2019, the German Bundestag passed the Schedule Service and Supply Act, generally aiming to improve service levels within the statutory health insurance system.
22 Apr 2019
United States
26 Mar 2019
The FDA And Cybersecurity: How The Agency Is Addressing Cybersecurity Risks To Medical Devices
Manufacturers should be aware of, and prepare for, the actions FDA undertakes on its own initiative and as a result of the OIG recommendations.
United States
13 Mar 2019
Jones Day Global Privacy & Cybersecurity Update | Vol. 21
Data privacy- and security-related class actions appear to be on the rise, and effectively defending them requires the right mix of substantive and procedural knowledge.
11 Mar 2019
Certain Pharmaceutical Discounts No Longer Safe Under The "Safe Harbors"?
Importantly, HHS does not intend for the proposed rule to have any effect upon existing protections for value-based arrangements.
United States
5 Mar 2019
French Food Safety Agency Launches Call For Information About Nanomaterials Used In Food
A similar call also could be carried out for nanomaterials potentially present as residues.
1 Mar 2019
United States
6 Feb 2019
Secret Sales Are Still Prior Art: U.S. Supreme Court Affirms Helsinn Healthcare
The Supreme Court unanimously finds that the AIA's "on sale" statutory language did not alter the pre-AIA "on-sale" bar.
United States
31 Jan 2019
Jones Day Talks Intellectual Property: Section 101, Life Sciences, And The Alice Two-Step
Section 101 of the U.S. Patent Act─which identifies four categories of inventions or discoveries that are eligible for patent protection─presents a number of challenges to companies working on innovations in the life sciences space.
United States
21 Jan 2019
Second Medical Use Patents In Europe: Are UK And Germany Swapping Approaches?
This White Paper defines "second medical use" claims and explains the "roles of intent" and "plausibility" in these infringement cases.
10 Jan 2019
Health Insurer Agrees To Largest Settlement Of A Health Data Breach
On October 15, the U.S. Department of Health and Human Services Office for Civil Rights ("OCR") announced that a health insurance company agreed to pay $16 million
United States
4 Jan 2019
Department Of Justice Moves To Dismiss FCA Cases Involving Patient Support Services
This week, the Department of Justice ("DOJ") moved to dismiss 10 False Claims Act ("FCA") cases around the country that challenged patient support services in the pharmaceutical industry.
United States
4 Jan 2019
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