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 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.
Increased regulatory attention may represent a new normal for Healthcare IT providers.
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.
Brad Ulrich, a senior engineer at Quandary Peak, is working on case about the development of electronic health record (EHR) software and software designed to meet Commission on Accreditation of Rehabilitation Facilities (CARF) compliance standards.
