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 [...]

Copyright Ruling May Pave Way for Greater Access to Medical Device Service Manuals

Two months ago, a little-known rulemaking proceeding was underway at the U.S. Copyright Office which, depending upon the outcome, was poised to have favorable implications for the use of electronic medical device equipment manuals by servicers. Today, the Librarian of Congress issued a ruling to accept for the next three years the recommendation of the [...]

By |2021-11-02T12:15:49+00:00November 2nd, 2021|Government, Governments, Healthcare, Legal Advice, Reform, Regulatory|Comments Off on Copyright Ruling May Pave Way for Greater Access to Medical Device Service Manuals

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

Biden’s Executive Order on Competition Offers Path Forward to ‘Repair Markets’

On July 9, 2021, President Biden issued a comprehensive executive order on competition. Entitled Promoting Competition In The American Economy, the order sets forth, in overview, measures designed for federal agencies to coordinate actions to address the problems of unfair competition, overconcentration, and economic consolidation. The executive order acknowledges the harmful anticompetitive effects of monopolies [...]

By |2021-07-22T11:09:01+00:00July 22nd, 2021|Reform, Regulatory, Uncategorized|Comments Off on Biden’s Executive Order on Competition Offers Path Forward to ‘Repair Markets’

U.S. House votes to kill sales tax on medical devices

The House of Representatives voted overwhelmingly Tuesday to kill a sales tax on medical devices that the medical-technology industry around the country have battled for nearly a decade.  Industry insiders hope that Tuesday’s vote will provide the momentum that leads to action by the end of the year. Read more here.

By |2018-07-25T12:49:06+00:00July 25th, 2018|Business, Regulatory|Comments Off on U.S. House votes to kill sales tax on medical devices

Ransomware targets healthcare industry the most: 4 things to know

For the second consecutive year, healthcare was the sector hardest hit by cyberattacks, according to Cylance's 2017 Threat Report released May 1.  In its report, Cylance — a cybersecurity firm that uses artificial intelligence to protect against threats — reviewed attacks that affected its global customer base, which spans multiple industry sectors, in 2017. Read [...]

By |2018-05-07T10:55:09+00:00May 7th, 2018|Business, Regulatory|Comments Off on Ransomware targets healthcare industry the most: 4 things to know

Servicing Legislation Update

On June 7, 2017, the U.S. House of Representatives Energy and Commerce Committee approved an amendment to the FDA Reauthorization Act of 2017 which will require the FDA to submit to the House and Senate Committees  a report on how the FDA intends to ensure the quality and continued effectiveness of devices with respect to [...]

By |2017-06-08T13:51:21+00:00June 8th, 2017|Government, Regulatory|Comments Off on Servicing Legislation Update
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