The future of healthcare lies in the successful integration of workflow automation and advanced technologies. As the buzz-word salad of AI, such as NLP, LLMs, Gen AI, RPA, etc continue to evolve, their potential to revolutionize healthcare workflows will only increase.
The EU Data Act will be applicable from September 12, 2025. Given the consequent steps that will be required to comply with the EU Data Act, medical and health devices’ companies would do well to already commence assessing what they will need to do to comply with it.
Study reveals limitations of large language AI models in medical coding.
Researchers have developed a new machine-learning model that can precisely make prognosis predictions for patients with osteosarcoma, based on the density of viable tumor cells post-treatment.
In addition to addressing cybersecurity risk management during the design and development of medical devices, the standard also contains clear guidance related to postmarket monitoring of device vulnerabilities, security measures such as patching, and the use of a software bill of materials.
Behavioral health providers were excluded from the 2009 HITECH Act, which contributed to significant disparities in EHR adoption between mental and physical health providers. The Behavioral Health Information Technology (BHIT) Coordination Act could help remedy this, yet regulatory and societal barriers to full interoperability remain.
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions provides recommendations on what information to include in premarket submissions and emphasizes that cybersecurity is a component of quality system regulation.
On August 11, the FDA released a Final Guidance on Off-the-Shelf Software Use in Medical Devices, which supersedes Off-The-Shelf Software Use in Medical Devices issued September 27, 2019.
Healthcare cyberattacks are becoming more common and more costly—both financially and to patient care continuity. Internet-connected IoMT devices and equipment remain a security concern for healthcare delivery organizations. Deeper collaboration between HDOs, medical device manufacturers and security providers is needed to reduce risk and vulnerability.
Large sets of data are collected throughout the surgical continuum, but are chief medical officers and perioperative leaders able to use that data to drive clinical, operational, and financial improvements? Embracing data-driven surgery can help HCOs make use of their data to improve care, reduce costs and better manage staffing and workflow.