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The US vs. the EU: A look at the pre- and post-market regulation of medical devices with Medtronic’s pacemaker devices as a case study.
The term “medical devices” is usually used very broadly when referring to a type of technology that helps patients with their health. There are challenges with the categorization of medical devices that might impact their approval process and their availability on the market for patients and providers to use. A slower and more diligent…
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Patient Centric Cybersecurity – Excerpt
Over the last several decades there has been a shift in standard models of healthcare both in the United States and globally. Patient centric approaches in health care reorient the power relationships of physicians and patients. This shift elevates the needs and challenges of the patients and builds a more robust and communicative relationship…