Medmarc Blog (blog.medmarc.com) | Medmarc Insurance (8)

COVID 19, Regulatory and Compliance, Centers for Medicare & Medicaid Services (CMS)

ONC, CMS Delay Compliance Dates for EHR Interoperability

May 01, 2020

The COVID-19 pandemic has incurred a number of regulatory casualties in recent weeks, and the final rules for electronic health records (EHRs) promulgated earlier this year are two of the...

2 minute read

COVID 19, Regulatory and Compliance

EMA Proposes Delay of MDR Implementation

April 17, 2020

As the world grapples with the newest version of the coronavirus, regulatory agencies across the globe are reacting with a number of moves, mostly to relax existing regulatory requirements. In...

3 minute read

FDA, COVID 19, Regulatory and Compliance

FDA Reacts to Coronavirus as Stimulus Bill Passes

March 30, 2020

The FDA is scrambling to meet the demands imposed by the COVID-19 outbreak, including a series of guidances dealing with a variety of issues. However, the predicament has also prompted two pieces...

3 minute read

COVID 19

Congress Sets Aside $8.3 Billion for Coronavirus

March 20, 2020

The U.S. federal government’s response to the COVID-19 outbreak has been criticized in some quarters as laggardly, but Congress sent a supplemental spending package to the White House in early...

3 minute read

FDA, Health and Human Services (HHS)

FY 2021 Budget Proposal Hits NIH, Mostly Flat for FDA

February 10, 2020

The Trump administration’s budget proposal for fiscal 2021 in large part reflected the administration’s past proposals for various agencies at the Department of Health and Human Services. While...

2 minute read

COVID 19

Coronavirus Prompting Reaction in Washington

February 10, 2020

The newest mutation to the coronavirus has had a massive impact in China and has prompted a reaction from the World Health Organization (WHO). The impact on makers of devices and diagnostics has...

2 minute read

FDA, Draft Guidance, Regulatory and Compliance

FDA Inks Combo Product Feedback Guidance

January 29, 2020

The FDA and industry have been at loggerheads over various issues surrounding combination products, but a new draft guidance may help resolve some of those conflicts. The draft deals with...

2 minute read

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ONC, CMS Delay Compliance Dates for EHR Interoperability

EMA Proposes Delay of MDR Implementation

FDA Reacts to Coronavirus as Stimulus Bill Passes

Congress Sets Aside $8.3 Billion for Coronavirus

FY 2021 Budget Proposal Hits NIH, Mostly Flat for FDA

Coronavirus Prompting Reaction in Washington

FDA Inks Combo Product Feedback Guidance