As the world of medical devices evolves to treat better and monitor patient health, cybersecurity remains a top priority. As per FDA guidance, “medical device security is a shared responsibility between stakeholders, including health care facilities, patients, providers, and manufacturers of medical devices.”
Read MoreThe FDA first drafted guidance on CDS software in 2017, but finalizing it has not been a priority for the agency since. That’s set to change next year. In late October 2021, the FDA’s Center for Devices and Radiological Health released proposed guidance documents for fiscal year 2022, with clinical decision support…
Read MoreThe digitization of medical records should lead to streamlined access for patients, efficiency upgrades for providers, and economic opportunity for developers. To date, these benefits exist in theory, but not in practice—due to cybersecurity concerns and the costs associated with interconnecting disparate, siloed systems, medical data is often made inaccessible to broader…
Read MorePractice Fusion – a subsidiary of leading healthcare IT provider Allscripts – has reached a $145 million agreement with the United States Department of Justice. The settlement is due to resolve potential criminal and civil liability facing Allscripts, as a result of Practice Fusion violations that allegedly occurred – and were initially…
Read MoreA primary goal of Health IT software is to improve the overall quality, safety, and effective delivery of healthcare. However, despite widespread implementation and use of health IT
software, these safety and quality benefits have not been fully realized, as software vendors and users must balance innovation with the ability to mitigate risk…
Quandary Peak was recently selected by a major EHR vendor to serve as a Software Quality Oversight Organization, charged with evaluating the company’s software and internal processes, and issuing software audit reports to improve the overall quality of their product, especially its ability to keep patients safe.
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