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First federal ‘right to repair’ legislation filed in US to help hospitals through pandemic

An opinion piece by Robert J. Kerwin Senator Ron Wyden (D-Ore) and Rep. Yvette Clark (D-NY) filed today in the U.S. Senate and the U.S. House of Representatives the first federal right to repair legislation. “There is no excuse for leaving hospitals and patients stranded without necessary equipment during the most widespread pandemic to hit [...]

By |2020-08-10T16:14:06+00:00August 10th, 2020|Government, Healthcare|0 Comments

Reviewing some of the key considerations for cyber insurance

June 24, 2020 By Robert J. Kerwin  The 2020 global increase in malicious cyberactivity against companies has been well reported. As of March 30, 2020, the FBI's Internet Crime Complaint Center (IC3) reported it had received and reviewed more than 1,200 complaints related to COVID-19 scams.  In a previously published report, the global cyber education [...]

By |2020-06-30T17:02:10+00:00June 30th, 2020|Uncategorized|0 Comments

New IMDRF Cybersecurity Guidance: Crystal Ball on Regulator Expectations

June 4, 2020By Robert J. Kerwin In the wake of the enormous increase in cybersecurity incidents, medical device regulators world-wide have been engaged in the development of pre-market and post-market guidance outlining cybersecurity expectations. In March, the International Medical Device Regulators Forum (“IMDRF”) released the guidance, “Principles and Practices for Medical Device Cybersecurity”.It is the first IMDRF [...]

By |2020-06-06T09:12:08+00:00June 6th, 2020|Uncategorized|0 Comments

Draft Standard on Refurbishing Equipment Could Lead to Greater Manufacturer Control

May 27, 2020 By Robert J. Kerwin  With the gradual reopening nationwide of the economy, we are understandably focused on getting back to business, while ensuring the health and safety of our families. Raising a discussion of new ‘refurbishing standards’ for certain non-imaging medical equipment may provoke the question: how could this be relevant to [...]

By |2020-06-03T21:17:58+00:00June 3rd, 2020|Uncategorized|0 Comments

AdvaMed and MITA exit collaboration with non-OEM service stakeholders

by Gus Iversen, Editor in Chief DOTmed In a setback for improved cooperation between different medical equipment service stakeholders, two of the leading manufacturer trade groups, the Medical Imaging & Technology Alliance (MITA) and AdvaMed, have announced they will no longer be participating with in-house and independent service organizations in FDA-recommended Medical Device Servicing [...]

By |2020-10-02T14:52:18+00:00May 21st, 2020|Uncategorized|0 Comments

HSCC Legacy Medical Device Task Group Aims to Mitigate Cyber Threats

May 13, 2020 By Robert J. Kerwin This article is reprinted with permission of DOTmed HealthCare Business News and can be read online in its original format at: https://www.dotmed.com/news/story/51199  In April, the FBI reported a global increase in malicious cyberactivity targeting U.S. Healthcare providers, noting that the cyberactivity was exploiting fear derived from the COVID-19 [...]

By |2020-05-14T16:45:54+00:00May 14th, 2020|Government, Healthcare|0 Comments

Implementation of the EU MDRs Delayed Until 26 May 2021

IAMERS continues its role, albeit virtually, as an official observer to the European Commission Medical Device Coordination Group. IAMERS has been participating in the MDCG Subgroup on the MDR regulations on Post Market Surveillance and Vigilance. Under these regulations, manufacturers will be furnishing to member country regulators no less than annually reports on the safety [...]

By |2020-05-12T17:16:23+00:00May 12th, 2020|Uncategorized|0 Comments

IAMERS Joins Healthcare Sector Coordinating Council Cybersecurity Working Group

IAMERS has joined on behalf of its members the Healthcare Sector Coordinating Council. The HSCC is a private-sector organized and managed council created to establish a process to coordinate improvements to the security of critical infrastructure. The U.S. Department of Homeland Security is required to engage and consider the advice of the Sector Coordinating Councils. [...]

By |2020-05-12T16:07:50+00:00May 12th, 2020|Uncategorized|0 Comments

Continued Advocacy

As many of you know we are continuing our advocacy (albeit virtually) with the Congress, EU and others. We wanted to bring to your attention, IAMERS latest efforts to advocate for greater access to service access information. Read more about our efforts here.

By |2020-05-12T13:32:19+00:00May 12th, 2020|Uncategorized|0 Comments

FTC needs to enforce pandemic moratorium on denying access to medical device service information

April 29, 2020 An editorial by Robert J. Kerwin Originally publish on DOTMed Health Care Business NewsWith a big tip of the hat to Captain Obvious, our hospitals and health delivery organizations are heroically dealing with a terrible pandemic the likes of which we have no real comparison for in our lifetime. As Healthcare Business News [...]

By |2020-05-12T13:28:39+00:00May 12th, 2020|Uncategorized|0 Comments
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