On July 21, 2025, the U.S. District Court confirmed again the propriety of the Librarian of Congress granting of a medical device repair exemption from the Digital Millennium Copyright Act (“DMCA”). The rule exempts parties accessing copyrighted software for the purpose of diagnosis, maintenance and repair of medical devices from the DMCA proscription barring circumvention [...]
We are excited to share our Annual Meeting Brochure. Can't wait to have you all join us.
We are excited to see you all soon at the 19th Annual IAMERS European Meeting. Read more about it here. Register to attend here.
IAMERS Founding member, Ed Sloan, gave an impressive keynote address focusing on leadership and how we should treat one another. Picture 1 & 2: Ed Sloan presenting. Picture 3: Left to Right: Rob Manetta, Ed Sloan & Dave Band Read more about his talk here.
May 07, 2025 By Robert J. Kerwin Last week IAMERS Founding Member Ed Sloan was honored with the IAMERS President’s Award at the 32nd Annual IAMERS Meeting in Nashville, Tennessee. The meeting was, as usual, content-rich but the highlight was a special ceremony honoring industry giant Ed Sloan. Surrounded on the dais by several of his [...]
The right of Hospitals to repair-- or to choose who will repair their own medical devices is integral to patient safety and to controlling costs. Never was this more apparent than during the Pandemic. Healthcare systems continue to face the existential challenge of sustained cost increases. As the American Hospital Association has noted, the financial [...]
By Robert J. Kerwin, IAMERS General Counsel EDITOR’S NOTE: This article is for informational purposes only and cannot be construed as providing legal advice. Readers are advised to consult their own counsel relative to the DMCA and its exemptions. It was originally posted on TechNation Robert J. Kerwin, IAMERS General Counsel The U.S. Register of [...]
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 [...]
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 [...]
