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Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Jones Day ordered by Published Date Descending.
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1
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
2
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
3
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.
UK
10 Jan 2019
4
Public Branding, The OIG's New Method Of Punishing Health Care Entities?
The total number of CIAs between the OIG and health care entities has been decreasing, and the OIG recently decided it would spotlight entities that decline to participate in these agreements.
United States
19 Dec 2018
5
Remedial Orders And The Public Interest Factors
Interestingly, Dell, a non-party, made a submission to the Commission as a customer of Toshiba's.
United States
11 Dec 2018
6
Jones Day Talks Health Care & Life Sciences: What Digital Health Innovators Should Know About The FDA Approval Process
Jones Day partner Ann Hollenbeck shares an informative conversation with associate Ian Pearson, who was a lead in the area of digital health at the U.S. Food and Drug Administration.
United States
9 Nov 2018
7
Sunshine Act Reporting Requirements Expanded To Physician Assistants And Advance Practice Nurses
A bill recently signed into law expands the reporting requirements under the Physician Payments Sunshine Act
United States
7 Nov 2018
8
Pharmaceutical Company Agrees To $625 Million False Claims Act Settlement
The Department of Justice ("DOJ") recently announced that it agreed with AmerisourceBergen Corporation ("ABC") and several of its subsidiaries to resolve a False Claims Act ("FCA") case for $625 million.
United States
18 Oct 2018
9
Jones Day Talks Health Care & Life Sciences: Medicare Appeals And Telemedicine Reimbursements
A recent Fifth Circuit decision is good news for health care providers struggling with the Medicare appeals process, but the agency's limited reimbursements for telemedicine services continue to frustrate providers.
United States
14 Oct 2018
10
Ninth Circuit Clarifies Import Of Escobar In False Claims Act Litigation
Courts have disagreed over whether Universal Health Services, Inc. v. Escobar, 136 S. Ct. 1989 (2016), announced a mandatory test for implied certification liability under the False Claims Act.
United States
25 Sep 2018
11
PTAB Grants Rare Motion For Additional Discovery
This is consistent with the limited discovery in proceedings held before the PTAB.
United States
30 Aug 2018
12
Enforcement Of The Next Generation Medical Infrastructure Act
The Act Regarding Anonymized Medical Data to Contribute to R&D in the Medical Field ("Next Generation Medical Infrastructure Act") ...
Japan
16 Jul 2018
13
FDA Draft Guidance Regarding Inclusion Of Pregnant Women In Clinical Trials
On April 3, 2018, FDA published long awaited draft guidance entitled " Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials."
United States
6 Jul 2018
14
The EU Pharma Incentives Review - Two Studies And A Legislative Proposal Released
On May 28 and 29, 2018, the Commission published two studies aimed at examining the economic and legal impacts of the EU's regime on SPCs in particular, as well as on pharmaceutical incentives and rewards in general.
European Union
20 Jun 2018
15
France Simplifies Local Medical Device Regulations And Sets Precedent For Other Member States
On April 26, 2018, the French administrative Supreme Court (Conseil d'Etat) issued a ruling that annulled Decree 2016-1716 of December 13, 2016 ("2016 Decree") ...
France
24 May 2018
16
FDA Permits Marketing Of First Autonomous Artificial Intelligence-Based Medical Device
On April 11, 2018, the U.S. Food and Drug Administration ("FDA") permitted marketing of the first device to use artificial intelligence ("AI") autonomously to detect a medical condition.
United States
24 May 2018
17
Medical Devices Repackaging And Parallel Imports: A "No-No" From The Milan Court
In a recent hallmark case, the Court of Milan ruled on the viability of medical devices parallel imports, where the parallel importer repackaged ...
Italy
30 Apr 2018
18
Jones Day Talks Health Care & Life Sciences: False Claims And Private Equity, And Rideshare Apps Race Into Patient Transportation
Jones Day's Ann Hollenbeck and Courtney Carrell discuss an unexpected False Claims Act action as a private equity firm faces FCA liability.
United States
25 Apr 2018
19
The Shifting Landscape Of Organ Allocation For Transplantation
The Organ Procurement and Transplantation Network ("OPTN")/ United Network for Organ Sharing ("UNOS") has recently modified the national lung allocation policy as a result of a court-ordered ...
United States
19 Apr 2018
20
Italian Supreme Court Upholds Class Action Ruling On Misleading Advertising
The Situation: On January 31, 2018, the Italian Supreme Court ruled on the first Italian product-related class action promoted by a consumers' association.
Italy
20 Mar 2018
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