The major health care and cybersecurity risk of ‘Right-to-Repair’ laws

Just like other devices we rely on, medical devices can improve our quality of life – as long as they work properly. If not serviced – or not serviced or serviced in accordance with FDA approval – there can be enormous health and cybersecurity risks.

In the letter accompanying a recently published FDA discussion paper, William Maisel states, “Many medical devices are reusable and require preventive maintenance and repair during their useful life; Therefore, proper maintenance is critical to their continued safe and effective use. ”Maisel, MD, is director of the Office of Product Evaluation and Quality at the FDA Center for Devices and Radiological Health. Who could contradict such a statement? Lawyers.

That’s right, the tort prioritizes gain over patient safety. To be ashamed of. (No, I’m not surprised either.)

Quality is the glue that holds our health technology ecosystem together. Whether it’s a drug for high blood pressure, a COVID-19 vaccine, or a medical device like an implantable stent or a room-sized MRI machine, the FDA’s mission is based on a triad of trust – safety, effectiveness, and quality. And the foundation on which quality rests is good manufacturing practice. Who could be against it? Lawyers.

Consider the recent spate of proposed state and federal laws on what is known as the “right to repair.” At first glance, it might seem like a good idea. Why not make it easier for consumers to repair their broken electronics without paying an expensive sum to the original equipment manufacturer? But, HL Mencken reminds us, “For every complex problem there is a clear, simple, and wrong answer.” The reality is that the right to repair has many dangerous unintended consequences. Problem # 1 is that it affects patient safety.

The essence of repair law laws is to require innovative technology companies to make product repair information, parts, and tools easily accessible to consumers and third-party repair shops. Should this be the case with devices such as automated external defibrillators and hospital ventilators? What about electrocardiograph (EKG) machines? Can doctors and patients rely on non-FDA-compliant providers if they don’t have the advanced training and technical skills to properly repair and recalibrate life-saving machines? Who could say “Anyone can do it?” Lawyers.

Why? Because when things go wrong, when medical devices fail, when patients and their families face the consequences, when the associated health care costs soar, lawyers seem to see opportunities. And with their lightning-fast processes, they target the deepest pockets – the original manufacturers.

It seems that the Tort Bar is creating a problem that they can take advantage of.

But wait, it’s getting worse. By allowing third parties without FDA expertise to repair regulated, complicated medical devices, Right-to-Repair also opens the door to cybersecurity violations.

According to the FDA, “Cyber ​​security is a widespread problem affecting medical devices that are connected to the Internet, networks, and other devices. Cybersecurity is the process of preventing unauthorized access, alteration, misuse, or denial of use or unauthorized use of information that is stored, accessed, or transmitted from a medical device to an external recipient. “

In the just released FDA Discussion Paper, to which I referenced above, “Strengthening Cybersecurity Practices Associated with Servicing Medical Devices: Challenges and Opportunities,” the agency asks, “How can medical device servicing companies improve the cybersecurity of medical devices.” contribute?”

According to the discussion paper, “the FDA defines a service as the repair and / or preventive or routine maintenance of one or more parts in a finished device after it has been sold to bring it back to the safety and performance specifications of the original device.” Manufacturer (OEM) and to meet its original purpose. “

In other words, the first step in improving the cybersecurity of medical devices is to limit control over the repair and maintenance of this advanced health technology and ensure that they are FDA regulated manufacturers.

The FDA will hold a public meeting on July 27th on the subject. It couldn’t be more up-to-date. The proper service and safety of medical devices and other health technologies should not be underestimated for profit.

Peter J. Pitts, former Associate Commissioner of the FDA, is President of the Center for Medicine in the Public Interest and Visiting Professor at the Faculty of Medicine at the University of Paris.

source https://collegeeducationnewsllc.com/the-major-health-care-and-cybersecurity-risk-of-right-to-repair-laws/