Regulation

Organizations are applauding the goals of transparency and patient access to medical data.

The platform assesses cognitive and motor function via at-home assessments that generate digital biomarkers and a predictive score, supporting the early detection of Parkinson's.

The FDA claims the wearable tech company's BPI offering is "adulterated" and "misbranded," and is being sold without the proper regulatory approvals.

ArteraAI Prostate analyzes digital pathology images of a prostate cancer biopsy slide to help clinicians predict long-term outcomes.

The wristband is designed to alleviate essential tremors by modulating the nervous system and restoring motor control.

Michael Needham, principal at Efficio, says the Trump administration's tariffs create uncertainty and indecision for business.  

Independent accreditation is essential to ensure that health technology and health organizations are compliant with HIPAA, NIST and other standards, says Kathryn Ayers Wickenhauser, DirectTrust's chief strategy officer.

Also, fellow Korean medical AI companies have obtained regulatory approvals across global markets. 

While the change of administration means federal regulations and funding remain in flux, PointClickCare's Brian Drozdowicz believes healthcare vendors and organizations are making strides in improving interoperability.