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Too often, regulations undermine the competitive process in the name of promoting competition. The ill-conceived Right to Repair legislation exemplify the problems and risks. Under the pretense of promoting competition, states as diverse as Texas and California, Arkansas and Hawaii have all considered bills that would violate medical device companies’ intellectual property rights. While many have been defeated, some legislators seem intent on …

Violating Manufacturer’s Property Rights Does Not Promote Healthy Competition Read More »

When selecting a new piece of medical imaging equipment, the demands of cost, functionality, and lifetime upkeep and maintenance are all taken into consideration. Those health care workers who will interact with the technologies involved want devices with the most expansive, up-to-date feature sets. Those who must maintain the equipment want the ability to do …

Right to Repair and Medical Imaging Device Purchasing Read More »

Medical device manufacturers say the Library of Congress’ final rule that allows third parties to access medical device data outputs and computing systems will make it easier for people to hack into medical devices and access sensitive data, which could jeopardize patient safety and threaten device makers’ intellectual property protections.

A recent recommendation by the U.S. Copyright Office allowing for the bypassing of technological protection measures (TPMs) in medical devices for purposes of repair, maintenance and service has been adopted and immediately put into effect. This is bad news for patient safety.

In Washington, D.C., no good deed ever seems to go unpunished. And so it is with innovators in our medical industry—companies that produce break through drugs, vaccines, and high-tech medical devices. As almost never before, these companies are under assault by Congress for the sin of being profitable. The most pernicious threat is the set of price controls on drug companies contained in the …

Biden’s Build Back Better would do real damage to medical innovation just when we need it most Read More »

In his October 5 commentary (Why the right-to-repair conversation needs to extend further), Lars Thording clearly lays out the challenges for the Right to Repair movement in healthcare as patient safety, cybersecurity, and the need to foster further health care innovation. However, the solution to these challenges should not be forcing the entire industry to …

Biden got it right on the Right-to-repair conversation by excluding medical devices Read More »

In May, Colonial Pipeline was hit with a ransomware attack on its computers that forced it to shut down its pipeline operations. It affected the fueling operations at multiple airports and caused many gas stations to run out of gas as consumers panicked. Ultimately, the company paid $5 million to the hackers to regain access …

US healthcare system vulnerable to cyberattacks, leaving patients at risk Read More »

The FDA has been deliberating over some obscure but important issues surrounding medical devices – specifically, whether certain maintenance and repair actions are “servicing” or “remanufacturing,” which has important implications both for the safety of the devices and for regulatory requirements.

The “Right to Repair” issue pertains to FDA-regulated medical devices and the unintended negative consequences for patient health and safety that would result if unregulated third-parties were allowed to work on these highly sophisticated pieces of equipment.

The other week, the HHS Inspector General released a report about just how little oversight the Medicare program has over medical device cybersecurity (and what little discretion is does have, it rarely uses).

Patients depend on safety and accuracy of medical equipment. If they’re improperly repaired, it could derail a patient’s healthcare journey and risk their health and safety.

For over a decade, I’ve had the privilege of working alongside patients from all walks of life to advocate for better healthcare through the national non-profit organization I co-founded and lead, Patients Rising. As an organization committed to prioritizing patient access, affordability, and safety, we watched with alarm as state Legislatures across the country became the …

Lessons learned from failure of medical ‘right to repair’ bill Read More »