FDA Approves Real-World Evidence for Drug & Device Reviews, Tech Sale Looms
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A landmark policy shift by the Food and Drug Administration and important activity in the health tech market are reshaping the landscape of healthcare innovation. The FDA’s decision too embrace real-world evidence (RWE) alongside ongoing developments in mergers,acquisitions,and data privacy are poised to accelerate advancements and empower patients.
The FDA announced on December 16, 2025, that it will now except de-identified real-world evidence to support applications for new drugs and medical devices.This represents a major departure from previous standards, which heavily relied on data from traditional clinical trials. The updated policy will incorporate data from previously excluded sources, including patient registries, insurance claims databases, and electronic health records (EHRs). “This change will allow for a more complete and efficient review process,” stated a senior official. “By leveraging the wealth of data already being collected, we can accelerate the approval of safe and effective treatments.”
Netsmart Sale Process Initiated
In a separate development,private equity firms GI Partners and TA Associates are preparing to launch a sale process for Netsmart in early 2026,according to sources familiar with the matter. This marks the second time the companies have sought a buyer for the health information technology firm. The move signals continued investor confidence in the market for healthcare IT solutions, especially those focused on behavioral health and post-acute care. One analyst noted that the timing of the sale could be strategic, capitalizing on the increased demand for interoperable health data systems.
Enjoin Expands Pediatric Expertise with Acquisition
Enjoin,a clinical documentation enhancement company,has acquired Pediatric Resource Group,bolstering its capabilities in specialized areas. The acquisition expands Enjoin’s expertise in APR-DRG assurance, clinical documentation integrity, and physician advisor solutions specifically tailored to children’s hospitals. According to a company release,the move will enable Enjoin to provide more comprehensive services to pediatric healthcare providers,improving documentation accuracy and optimizing revenue cycle management.
Senator Wyden Urges EHR Privacy Enhancements
Concerns surrounding patient data privacy continue to gain momentum. On December 16, 2025, Senator Ron Wyden (D-OR) called on health tech companies and EHR vendors to implement enhanced privacy features. Wyden is urging thes companies to adopt systems that allow patients to directly view and control access to their medical records. “Patients deserve to have full ownership and clarity over their health information,” Wyden stated. “EHR vendors have a responsibility to provide the tools necessary for patients to exercise that right.” This call to action underscores the growing demand for patient-centric data management solutions and the need for robust data security measures.
These converging developments – the FDA’s embrace of RWE, the potential sale of Netsmart, Enjoin’s strategic acquisition, and Senator Wyden’s privacy push – co
Why: The core shift is driven by a desire to accelerate healthcare innovation, improve efficiency in drug/device approval, and address growing concerns about patient data privacy. The FDA wants to leverage existing data sources for faster approvals, while market forces (investor
