PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA
The Sunshine Act: Putting It into Practice – Interview with Karen Lovitch, Member, Mintz Levin
Considerations for Biopharma Under a First-Inventor-to-File Regime
Hot Companies in Digital Health
Digital Health: Where is the Action for Entrepreneurs?
Southern Spine announced recently that StabiLink® MIS Interlaminar Spinal Fixation System has been chosen as the Silver Winner in the Implant and Tissue Replacement category of the 18th Annual Medical Design Excellence Awards...more
VertiFlex, Inc., announced that it has been granted pre-market approval by the FDA for its minimally invasive treatment of lumbar spinal stenosis, the Superion Interspinous Spacer System. This approval comes after a...more
In This Issue:
- The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities
- Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers
This Week: Leading Up to the SCOTUS King v. Burwell Decision... House Votes to Repeal the Medical Device Tax... CMS Announces It Will Bolster Transitional Reinsurance Payments... MedPAC Releases June Report to Congress....more
On the third day, the Center for Biologics Evaluation and Research (CBER) conducted its own Town Hall. CBER Director, Karen Midthun, explained how CBER works proactively to help develop new biological therapies. For example,...more
Last week, the House of Representatives voted 280-140 to pass H.R. 160, a bill that eliminates the 2.3 percent medical device tax. The vote was strongly bipartisan with 46 Democrats joining all Republicans voting in favor of...more
The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care...more
In this Presentation:
- Internet of Things - definition
- But what is it all about?
- But not just that...
- The IoT market in figures...
- Beecham Research - view of the World
- The Connected...more
Changes affecting the approval of medical devices are coming. On May 6, 2015, Health Canada released a draft List of Recognized Standards for medical devices for stakeholder consultation.
The consultation period is open...more
In This Issue:
- Judgments; Legislation; and Reports.
- Excerpt from Judgements:
New South Wales.
O'Sullivan v Medical Council of New South Wales  NSWCATAD 113
The New South Wales Civil and...more
This Week: GOP Post-King Contingency Bills Released in Both the House and the Senate... House E&C Committee Draft LDT Bill – Creates FDA In Vitro Center, Sets Agency Review Timeline and Defines Risk Categories... CMS...more
The House Energy and Commerce Committee unanimously approved H.R. 6, the “21st Century Cures Act,” on May 21, 2015, after reaching a bipartisan agreement to fund the legislation (Cures bill). Often described as a “landmark...more
On May 26, 2015, Connecticut Governor Dannel P. Malloy signed into law Public Act 15-11 (PA 15-11), “An Act Concerning Persons Who Decontaminate Reusable Medical Instruments or Devices.” This new legislation requires central...more
The short answer is “no.” We are just borrowing a line from one of the original gangster movies, “Little Caesar,” which readers other than McConnell would most likely know from references in “The Sopranos,” if they know it...more
This Week: House E&C 21st Century Cures Bill Passes Unanimously Out of Committee... House Votes to Codify Permanent R&D Tax Credit... CMS Released Proposed Rule Concerning Medicaid and CHIP Plans....more
Since the general disclosure rule for provider-manufacturer relationships in France was enacted into law on January 1, 2012, its compliance and enforcement have been a common point of discussion for health care professionals,...more
Today the House Energy and Commerce Committee is marking up H.R. 6, the 21st Century Cures Act, a high-profile, bipartisan bill that seeks to accelerate the pace of medical cures in the United States through a variety of...more
Shockwave Medical, based in Fremont, Calif., develops technology for the treatment of peripheral and coronary vascular disease and aortic stenosis. It is the developer of Lithoplasty balloon catheters....more
In This Issue:
Judgments; Legislation; and Reports & Publications.
Excerpt from Reports:
Australian Medical Association (AMA)
- 19 May 2015 - $19 billion pharmacy deal sign of skewed health...more
In This Issue:
- 21st Century Cures Markup; Full Committee to Take Up this Week
- Senate Finance Committee Solicits Health Bills for Upcoming Markup
- Implementation of the Affordable Care Act
This Week: Health Subcommittee Advances 21st Century Cures, Full Committee Action Scheduled…Senate Finance Committee Hearing: Chair Hatch to Launch New Initiative on Improving Chronic Care for Medicare Patients…Hawaii’s...more
Just so you know, that iPhone or iPad you have with you may be an FDA-regulated medical device. More precisely, the apps on the device may meet the definition of a medical device under the Federal Food, Drug, and Cosmetic Act...more
On May 11, 2015, Connecticut Governor Dannel P. Malloy signed into law Public Act 15-4, “An Act Concerning Reporting of Payments by Manufacturers to Independently-Practicing Advanced Practice Registered Nurses” (P.A. 15-4)....more
The U.S. Food and Drug Administration (FDA) initiated an Expedited Access Pathway (EAP) Program, effective April 15, 2015, for certain medical devices that are subject to premarket approval applications (PMAs) or de novo...more
In line with a nationwide movement, on April 21, 2015, Governor Fallin signed into law House Bill 1074, the Oklahoma Right to Try Act. The Act allows physicians to prescribe to terminally ill patients investigational drugs,...more
Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up to create your digest using LinkedIn*
Back to Top