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 [...]

OEM trade groups may be seeking to expand definition of ‘remanufacturing’ quickly and quietly

An op-ed by Robert J. Kerwin As the 2021 Federal Trade Commission (FTC) report to Congress on repair restrictions acknowledged, some medical equipment manufacturers are limiting the availability of diagnostic software and firmware necessary to make repairs. That situation may soon worsen, if legislation proposed by a manufacturer trade association is filed and approved. This [...]

By |2022-03-24T14:08:38+00:00March 24th, 2022|Business, Government, Healthcare|Comments Off on OEM trade groups may be seeking to expand definition of ‘remanufacturing’ quickly and quietly

Considerations for effective healthcare vendor management in 2022

At the annual IAMERS educational meeting in Chicago last week, IAMERS took a deep dive on vendor management trends and best practices with two seasoned industry veterans. Intermountain Healthcare's director of clinical engineering, Michael Powers, and Crothall Technical Resources' vice president, Sheila O’Donnell, presented on 2022 best practices. The 90-minute discussion drilled down about the [...]

By |2021-12-09T17:50:53+00:00December 9th, 2021|Business, Conference, Healthcare|Comments Off on Considerations for effective healthcare vendor management in 2022

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 [...]

By |2021-09-07T17:35:30+00:00September 7th, 2021|Business, Government, Governments, Healthcare, Imaging, Legal Advice, Reform, Regulatory, Used Medical Equipment|Comments Off on FDA Says Sharing Device Manuals With ISOs Does Not Create Cybersecurity Concerns

FDA Remanufacturing Guidance Comment Period Extended

On June 24, 2021, the FDA released a draft version of the FDA Remanufacturing Guidance. At the request of industry, the time frame for providing written comments to the guidance has been extended to September 22, 2021. In 2018, the agency disseminated a remanufacturing white paper, and now the circulation of a draft guidance indicates [...]

By |2021-08-05T21:07:51+00:00August 5th, 2021|Business, Government, Healthcare|Comments Off on FDA Remanufacturing Guidance Comment Period Extended

Brexit agreement begins now: Are you ready?

By Robert J. Kerwin It was four years ago that Britain’s then-prime minister, David Cameron, set a referendum on  the U.K.’s continued membership in the European Union. In June 2016, the citizens of the U.K.  voted to leave the EU.  In January 2020, the U.K. officially withdrew, and since that time the EU and the [...]

By |2021-01-06T03:54:31+00:00January 6th, 2021|Business, Government, Healthcare|Comments Off on Brexit agreement begins now: Are you ready?

Predicting Growth in Ultrasound Markets—Six Predictions

With healthcare costs continuing to rise, affordable and accurate imaging and diagnosis achieved through ultrasound will continue to attract patients, according to a new market report from Fact.MR. The report on the global market for ultrasound systems projects steady growth for the market from 2017 to 2022, from a value of $6 billion in 2017 [...]

By |2019-05-02T14:22:18+00:00May 2nd, 2019|Business|Comments Off on Predicting Growth in Ultrasound Markets—Six Predictions

AHA calls on hospitals, health systems to compete with ‘disruptors’

In a recent speech, Richard Pollack, President and CEO of the American Hospital Association noted that new entrants into the healthcare sector, such as Amazon, Apple and Google, are poised to serve as “disruptors” in the industry.  “We are seeing historic—if not unprecedented—change across the entire healthcare landscape,” Pollack told an AHA forum in Washington. “There’s no [...]

By |2019-03-26T10:00:15+00:00March 26th, 2019|Business|Comments Off on AHA calls on hospitals, health systems to compete with ‘disruptors’

Survey: Healthcare executives spotlight the sweeping policy changes they see coming for the industry

Hooper, Lundy & Bookman, PC, a healthcare law firm, polled more than 220 healthcare executives from across the spectrum and found 74% believe significant policy change is either very likely or somewhat likely in the next two years. Read more here.

By |2019-02-21T17:12:46+00:00February 21st, 2019|Business|Comments Off on Survey: Healthcare executives spotlight the sweeping policy changes they see coming for the industry

Philips kicks off new year with realigned business segments

When speaking about the growth of the Image-Guided Therapy businesses, Frans van Houten, CEO of Royal Philips, said in a statement. “To strengthen our leadership in this fast-growing market, we have significantly invested in our R&D programs, which resulted in the launch of the very successful Azurion next-generation image-guided therapy platform, and the acquisitions of Volcano, [...]

By |2019-01-17T12:38:09+00:00January 17th, 2019|Business|Comments Off on Philips kicks off new year with realigned business segments
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