Category: Regulatory

October 15, 2018

Major drugmakers will soon include price information in television advertisements, conceding to the Trump administration but not as far as the administration may have hoped. Starting April 15, 2019, members of the Pharmaceutical Research and Manufacturers of America trade group […]

October 15, 2018

The adoption of the ISO 45001 standard is a watershed moment for operational health & safety (OH&S). With the new standard now published, it provides organizations a structure around which they can work to prevent workplace injuries, illnesses, and fatalities. […]

September 27, 2018

A settlement binding all potential plaintiffs may be the only practical way of ending nearly 2,000 lawsuits against manufacturers, distributors and retailers of addictive opioid painkillers, said plaintiff lawyers attending a conference on opioid litigation this week. Some 1,200 lawsuits […]

September 27, 2018

Veterans Integrated Service Network 20 in the Pacific Northwest will serve as the first initial operating capability site to deploy and test the VA’s new Cerner electronic health record system. The planned acquisition calls for aligning the deployment of the […]

September 26, 2018

The Centers for Medicare and Medicaid Services must remove restrictions that hamper Medicare providers’ ability to offer telehealth services. Chief among those limitations, according to Morgan Reed, executive director of the Connected Health Initiative, is the fact that the Medicare […]

September 21, 2018

The federal agency in charge of healthcare delivery is seeking to increase the dialogue on increasing innovation and investment in healthcare. Eric Hargan, Health and Human Services Deputy Secretary, is looking to foster high-level dialogue between HHS and the private […]

September 19, 2018

James Gfrerer, the Trump administration’s pick to serve as chief information officer at the Department of Veterans Affairs, is a step closer to overseeing the VA’s IT infrastructure. The Senate Committee on Veterans’ Affairs on Tuesday approved Gfrerer’s nomination, which […]

September 18, 2018

The FDA has a regulatory dilemma on its hands with e-cigarettes. In one sense, the government might want to encourage e-cigarette use as a public health policy because if e-cigarettes replace regular cigarettes they would save lives and billions of […]

September 17, 2018

Payers must balance patient access to biopharmaceuticals and cost containment. A public payer such as Medicare and its contractors is no different in this regard. Yet, payers may in some cases be constrained in the kinds of methods they can […]

September 14, 2018

With Hurricane Florence making landfall, Health and Human Services Secretary Alex Azar has waived sanctions and penalties under certain provisions of the HIPAA Privacy Rule. While the HIPAA Privacy Rule is not suspended during a public health or other emergency, […]

September 14, 2018

The US Food and Drug Administration (FDA) has revealed plans to support the Pediatric Device Consortia (PDC) programme aimed at the development, production and distribution of paediatric medical devices. The regulatory authority awarded five grants totalling up to $6m a […]

September 11, 2018

A national hospital organization has voiced its support for a new $100 million Federal Communications Commission pilot program meant to boost the use of telehealth for low-income and rural Americans. The American Hospital Association on Monday sent a comment letter […]

September 4, 2018

The Food and Drug Administration is ramping up its efforts to leverage billing, claims, EHR and registry data to better inform the agency’s regulatory decisions regarding drugs and other medical products. This real-world evidence (RWE) could help to “answer questions […]

August 30, 2018

Responding to the recent departures of senior leaders at the Department of Veterans Affairs, a House subcommittee chairman is worried that the VA office in charge of EHR modernization is floundering. Last month, the VA established the Office of Electronic […]

August 27, 2018

The Department of Veterans Affairs has lost a key IT architect who had been working to ensure that the VA’s planned rollout of a $10 billion Cerner electronic health record system comes off without a hitch. Genevieve Morris, a Trump […]