The 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.
The FDA has announced updated software guidance for Software in a Medical Device (SiMD) or Software as a Medical Device (SaMD).
The digitization of medical records should lead to streamlined access for patients, efficiency upgrades for providers, and economic opportunity for developers. These benefits exist in theory, but not in practice—due to cybersecurity concerns and the associated costs.
In a piecemeal regulatory environment, consumers will bear the brunt of the responsibility for vetting any app they choose to give access to their medical information. How that information is protected will be the province of third parties – until legislated otherwise.
DNA phenotyping has the potential for positive use cases for law enforcement, but it is still early days for the technology. As it evolves, it appears more information and review are necessary to come to a true conclusion about its efficacy – and to develop the guidelines and processes to safely use it.
Increased regulatory attention may represent a new normal for Healthcare IT providers.
A 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 in these highly valuable systems.
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.