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Category: Regulatory


Regulatory

HHS wants private sector input on healthcare innovation, investment

September 21, 2018

Via: Health Data Management

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 […]


Regulatory

Senate panel approves Trump nominee to serve as VA CIO

September 19, 2018

Via: Health Data Management

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 […]


Regulatory

E-Cigarette Math And The FDA’s Regulatory Dilemma

September 18, 2018

Via: Forbes

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 […]


Regulatory

Medicare Advantage Plan Proposed Use Of Step Therapy For Part B Drugs

September 17, 2018

Via: Forbes

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 […]


Regulatory

HHS issues HIPAA waiver for covered hospitals in wake of Hurricane Florence

September 14, 2018

Via: Health Data Management

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, […]


Innovation, Medical Devices, Regulatory

FDA funds paediatric medical devices development

September 14, 2018

Via: medicaldevice-network.com

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 […]


Innovation, Med Tech, Regulatory

AHA voices support for $100M FCC telehealth pilot program

September 11, 2018

Via: Health Data Management

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 […]


Regulatory

FDA looks to bolster regulatory decisions using real-world data

September 4, 2018

Via: Health Data Management

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 […]


EHR & EMR, Regulatory

Congressman voices concerns about VA Office of EHR Modernization

August 30, 2018

Via: Health Data Management

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 […]


Regulatory

Morris resignation could signal trouble with VA EHR plans

August 27, 2018

Via: Health Data Management

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 […]


Innovation, Medical Devices, Regulatory

FDA approves device to treat obsessive-compulsive disorder

August 20, 2018

Via: Health Data Management

The Food and Drug Administration has cleared a device that uses magnetic fields to stimulate nerve cells in the brain for the treatment of a common mental illness. The procedure, called transcranial magnetic stimulation, was approved by the FDA as […]


EHR & EMR, Regulatory

HHS awards $125M to bolster the use of IT by health centers

August 17, 2018

Via: Health Data Management

The Department of Health and Human Services has awarded $125 million in quality improvement grants throughout the country. The agency says the funds will be used to upgrade the health information technology at 1,352 health centers in all 50 states, […]


Regulatory

FCC supports rural broadband deployments to enable telehealth

August 17, 2018

Via: Health Data Management

The Federal Communications Commission is putting its money where its mouth is when it comes to ensuring that rural Americans are able to connect to quality healthcare through the deployment of high-speed broadband. Earlier this month, the FCC unanimously approved […]


Innovation, Medical Devices, Regulatory

FDA clears mobile contraceptive app for women

August 13, 2018

Via: Health Data Management

A federal agency has approved an app that analyzes a woman’s basal body temperature and identifies when ovulation has occurred. The Food and Drug Administration has cleared the app as a method of contraception to prevent pregnancy. Called Natural Cycles, […]


Regulatory

FCC approves $100M Connected Care Pilot Program

August 3, 2018

Via: Health Data Management

The nation’s lead agency regulating interstate communications has passed a plan to expand the use of telemedicine solutions. The Federal Communications Commission on Thursday unanimously approved a new $100 million Connected Care Pilot Program supporting the use of remote telehealth […]