FDA Says Sharing Device Manuals With ISOs Does Not Create Cybersecurity Concerns

A little-known rulemaking proceeding is underway at the U.S. Copyright Office which, depending upon the outcome, may have profoundly favorable implications for the use by servicers of electronic medical device equipment manuals. Every three years under the Digital Millennium Copyright Act (“DMCA”), the Librarian of Congress, upon receipt of the recommendation of the Register of [...]

Biden’s Executive Order on Competition Offers Path Forward to ‘Repair Markets’

On July 9, 2021, President Biden issued a comprehensive executive order on competition. Entitled Promoting Competition In The American Economy, the order sets forth, in overview, measures designed for federal agencies to coordinate actions to address the problems of unfair competition, overconcentration, and economic consolidation. The executive order acknowledges the harmful anticompetitive effects of monopolies [...]

By |2021-07-22T11:09:01+00:00July 22nd, 2021|Reform, Regulatory, Uncategorized|0 Comments

New legislation would mandate all ISOs register with FDA

IAMERS Counsel Robert Kerwin to appear on May 2, 2017 before the U.S. House of Representatives Committee on Energy and Commerce on the Legislation. On Tuesday, April 25, 2017, Congressman Ryan Costello (R-PA) and Congressman Scott Peters (D-CA) with the support of the Medical Imaging Technology Alliance, filed H.R. 2118 seeking to require registration of [...]

By |2017-04-28T06:46:04+00:00April 28th, 2017|Government, Legal Advice, Reform, Regulatory|0 Comments

U.S. Struggles to Meet PPACA (Obamacare) Deadlines

July 10, 2013, The Wall Street Journal, LAURA MECKLER, JENNIFER CORBETT DOOREN and PETER NICHOLAS When Obama administration officials delayed a central plank of the new health law—requiring that big employers offer health insurance to workers—they said it was to help businesses pleading for more time. Left unsaid was the federal government hadn't written key [...]

By |2013-07-10T12:31:17+00:00July 10th, 2013|Business, Government, Healthcare, Reform|0 Comments

IAMERS Medical Device Excise Tax Letter

Here is a copy of the letter from Rob Kerwin, General Councel for IAMERS, to Kara Getz, Esq., Tax Counsel to the Hon. Richard E. Neal, U.S. House of Representatives, regarding the January 2013 Medical Device Excise Tax. It is our priority to get clarification from the Department of Treasury on whether or not the excise tax applies to [...]

By |2012-12-12T17:21:42+00:00December 12th, 2012|Government, Healthcare, Medical, Reform|3 Comments

The Accountable Care Organization. The Changing Face of Health Care Delivery in the U.S.

by: Wayne Webster The Accountable Care Organization (ACO) is a part of the enacted legislation of March, 2010 known as the Patient Protection and Affordable Care Act (Obama Care). The intent of the ACO is to streamline the delivery of care and reduce costs through the application of quality systems and measurements including the adoption [...]

By |2012-07-10T17:47:40+00:00July 10th, 2012|Government, Healthcare, Reform|0 Comments

IAMERS Partnerships

As part of our ongoing efforts in Washington, DC, we routinely meet with the following groups to discuss and unite for our common interests: National Rural Health Association (NRHA) – is a trade association of small hospitals who have problems with accessibility that many of our IAMERS members face.  The NRHA is a national membership [...]

By |2012-07-09T23:53:28+00:00July 9th, 2012|Government, Healthcare, Reform|0 Comments
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