IAMERS 33rd Annual Meeting Announcement
We are very excited to announce our 33rd Annual IAMERS Meeting. We have a lot in store with some interesting talks. Check out the brochure, and register here.
FDA issues letter supporting continuation of DMCA exemption for repair of medical devices
As the U.S. Copyright Office conducts its triennial Section 1201 rulemaking proceeding on DMCA exemptions this year, the FDA has issued a letter supporting the proposed renewal of the DMCA Exemption Regarding Repair of Medical Devices and Systems. On June 21, 2024, Suzanne Schwartz, director of the FDA Office of Strategic Partnerships and Technology Innovation, informed the [...]
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 [...]
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 [...]
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 [...]
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 [...]
2024 IAMERS Who’s Who
We are excited to announce the release of the 2024 IAMERS Who's Who. Click here to learn more.
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 [...]
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 [...]