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Decision in Lawsuit Allowing Medical Device DMCA Exemption Reversed in Appeals Court

On June 7, 2024, the U.S. Court of Appeals issued a decision reversing the U.S. District Court dismissal of the challenge by MITA and AdvaMed to the Librarian of Congress’ granting of an exemption from the Digital Millenium Copyright Act’s (“DMCA”) anti-circumvention provision pertaining to medical device manuals. Two independent medical device servicers had sought [...]

New Delaware legislation to review hospital budgets may only create new bureaucracies and problems

It is well understood that healthcare systems in the United States are navigating an ever-challenging operating environment. In the wake of the COVID-19 pandemic, increased costs, tightening labor markets and lagging reimbursement rates — all have contributed to significant financial stresses on the national healthcare system. In Delaware, like many other states, between Medicaid and [...]

By |2024-05-22T14:54:03+00:00May 22nd, 2024|Uncategorized|Comments Off on New Delaware legislation to review hospital budgets may only create new bureaucracies and problems

FDA Releases Final Guidance on Manufacturing

Today the FDA released its final guidance to provide the medical device industry clarity on the definition of "remanufacturing" for reusable devices needing maintenance or repair, a lingering point of ambiguity in an overarching discussion about right-to-repair. A draft of the guidance was initially released for comment and consideration back in 2021, at which time [...]

By |2024-05-13T17:59:16+00:00May 13th, 2024|Uncategorized|Comments Off on FDA Releases Final Guidance on Manufacturing

IAMERS Celebrates Its 31st Birthday

Last week, IAMERS (the International Association of Medical Equipment Remarketers and Servicers) celebrated its 31st birthday in Charleston at the IAMERS Annual Meeting. After IAMERS President Diana Upton welcomed the group, the Annual Meeting kicked off with a keynote presentation by Dr. Mike Bivins, president of Urology Centers of Alabama. Dr. Bivins offered some candid [...]

By |2024-05-10T15:41:04+00:00May 9th, 2024|Uncategorized|Comments Off on IAMERS Celebrates Its 31st Birthday

Can the EU Data Act Help Solve US Right to Repair Issues?

By Robert J. Kerwin While efforts in Washington D.C., and indeed nationwide, have sparked momentum toward widespread acceptance of the rights of device owners to choose who would repair the devices they own, recent approval by the European Parliament and the Council of the EU of the European Data Act may be a great leap [...]

By |2024-04-25T15:07:09+00:00April 25th, 2024|Uncategorized|Comments Off on Can the EU Data Act Help Solve US Right to Repair Issues?

Save the Date – IAMERS 31st Annual Meeting

Dear Members, We’re looking forward to seeing you in the beautiful city of Charleston for the 31st Annual IAMERS meeting. Meeting Times Monday 29th April 6:30 pm – Reception & Dinner at The Charleston Place Tuesday 30th April 8:00 am – Breakfast 9:00 am – Business sessions (lunch included) 4:00 pm – Meeting adjourns for the [...]

By |2024-02-15T19:28:45+00:00February 15th, 2024|Uncategorized|Comments Off on Save the Date – IAMERS 31st Annual Meeting

Inaugural Healthcare ‘Chief Competition Officer’ Appointed by HHS

January 10, 2024 By Robert J. Kerwin On Monday the U.S. Department of Health and Human Services announced the creation of a new HHS officer position entitled ‘chief competition officer’ to promote competition and lower health care costs. Stacy Sanders, most recently counselor to HHS secretary Xavier Becerra, will assume the role. While some industry [...]

By |2024-01-11T17:02:43+00:00January 11th, 2024|Government, Healthcare|Comments Off on Inaugural Healthcare ‘Chief Competition Officer’ Appointed by HHS

IAMERS Question of the Day

Recently Michelle Fields, W7 Global (USA) asked Christian Frandsen, Agito Medical (Denmark) the following question. Christian is a logistics expert – worldwide. ––––––––– Christian, Hello! I sat in on your talk about Logistics at the IAMERS meeting in Greece.  I have a question I am not sure if you can answer or direct me to [...]

By |2023-11-13T20:17:52+00:00November 13th, 2023|Uncategorized|Comments Off on IAMERS Question of the Day

Upcoming 2024 IAMERS Events

ECR – Vienna 28 Feb – 3 Mar 2024 IAMERS Member Reception Thursday 29th Feb 2024 7pm – 10pm Palais Hansen Kempinski __ IAMERS 31st Annual Meeting 29th Apr – 1st May 2024 The Charleston Place Charleston, SC __ IAMERS 18th Annual European Meeting 18th & 19th Sept 2024 Pulitzer Hotel Amsterdam, NL __ [...]

By |2023-11-13T20:10:28+00:00November 13th, 2023|Uncategorized|Comments Off on Upcoming 2024 IAMERS Events
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