The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills seeking to amend the Federal Food, Drug, and Cosmetic Act (“FDCA”) to clarify how drug and device manufacturers can legally discuss uses of
This past year, FDA’s (Center for Devices and Radiological Health CDRH) has dealt with several widely-publicized public health issues related to medical devices. Read More: When to Alert the Public? FDA Issues New Draft Guidance Document Regarding Public Notification of Potential “Emerging” Safety Issues with Medical Devices
Though the U.S. Department of Health and Human Services Office for Civil Rights (OCR) has told organizations to expect the Phase 2 HIPAA audits soon for almost two years now, it appears that the audits truly are around the corner. Read More: ‘Tis the Season . . . to Prepare for Phase 2 HIPAA
The U.S. Department of Health and Human Services (HHS) held a forum on Friday, November 20 entitled, “HHS Pharmaceutical Forum: Innovation, Access, Affordability and Better Health.” Read More: HHS Pharmaceutical Forum: “Innovation is Meaningless if No One Can Afford It”
In 2014 there were a number of significant antitrust developments for the pharmaceutical industry.
This week the Federal Communications Commission’s (FCC’s) CONNECT2HEALTHFCC Task Force, a group formed in March 2014 that is focused on using broadband deployment to accelerate the adoption of advanced healthcare technologies, is joining more than 400 other public and private organizations in recognizing National Health IT Week (NHIT week). NHIT week is a series of
In April the U.S. Food and Drug Administration released two draft guidance documents related to premarket approval applications for medical devices. The first outlined an Expedited Access PMA program, building off the earlier pilot Innovation Pathway program. The second addressed the FDA’s plans for balancing premarket and postmarket data collection efforts. Both forms of guidance
In the span of three days, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) published two proposed rules in the Federal Register that substantially modify OIG’s exclusion and Civil Monetary Penalty (CMP) authorities. Below we summarize the major provisions of each proposed rule. Read More: HHS-OIG Proposes Significant
The governmental order on the unique public website set up under the French sunshine regulations was published today. The order provides details on this website, managed by the French authorities, which will make available to the public the information to be reported by the industry under the sunshine regulations.
A mere two weeks before the health insurance marketplaces created by the Patient Protection and Affordable Care Act (“ACA”) are scheduled to open for enrollment, the Subcommittee on Regulatory Reform, Commercial and Antitrust Law of the House Committee on the Judiciary heard testimony on the effect of the ACA on health care competition. Representatives from
On 5 July 2012, Medicines Australia, the pharmaceutical industry association in Australia, announced the adoption of its new Code of Conduct. Although the Code is not legally binding, it reflects a growing tendency, partly legislative in nature and partly through industry self-regulation, to promote transparency in relationships between the pharmaceutical industry and healthcare professionals and