By Robert J. Kerwin Last week, the U.S. Copyright Office announced that it is once again accepting petitions for temporary exemptions, as well as petitions to renew existing temporary exemptions, under section 1201 of the Digital Millennium Copyright Act, 17 U.S.C. § 1201, through its triennial rulemaking proceeding. Petitions for new exemptions and petitions for renewal [...]
We are very excited for the upcoming 20th Annual European Meeting 16 & 17 September 2026 Le Royal Hotel • Luxembourg Check out the Luxembourg E-Brochure. Check out the Luxembourg Speakers. Join us Luxembourg 2026 Registration.
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.
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 [...]
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 [...]
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 [...]
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 [...]
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 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 [...]
We are excited to announce the release of the 2024 IAMERS Who's Who. Click here to learn more.
