Digital Health

• The surge in digital transformation and IoT medical devices is exposing healthcare organizations to heightened information‑security risks and potential data breaches. 
• Securing senior executive buy‑in is identified as the cornerstone for launching and sustaining effective IT risk‑management programs in large health systems. 
• Enterprise risk managers must assemble cross‑functional teams, engage skeptics early, and apply industry frameworks such as NIST, HIPAA, ISO 27001, and IEC 80001‑1 to identify and assess threats. 
• A structured seven‑step process, risk identification, evaluation, prioritization, mitigation planning, implementation, monitoring, and realistic scheduling, ensures continuous protection of clinical operations. 

AI

• FDA is loosening regulatory oversight of certain digital health tools, including AI‑enabled devices and clinical decision support software, as part of an effort to encourage innovation and move regulation “at Silicon Valley speed.”
• Some AI tools can now enter the market without FDA review if they don’t trigger stricter definitions of medical devices, meaning products that offer guidance without claiming to diagnose or treat may face little to no federal oversight.
• This policy shift could allow more generative AI and advanced analytics to be used in clinical workflows without the traditional safety and efficacy evaluations that regulated medical devices undergo.
• Critics worry the easing of regulation increases risk since many AI health technologies still lack robust clinical validation and standardized safety measures; this raises concerns about patient safety and accuracy in real‑world use.

Aus/NZ

• NSW government is rolling out a Digital Hub that will centralise data from all 6,000 preschools and long‑daycare centres, requiring them to upload enrolment, fee, consent and attendance information to third‑party Child Care Management System platforms. 
• Preschool administrators, such as Susie Godden of Nimbin Community Preschool, warn that the hub’s reliance on private platforms and staff without Working With Children Checks raises serious privacy and security concerns for children’s personal details.  
• Parents and researchers have reported actual breaches, including publicly accessible URLs containing birth certificates and photos, highlighting gaps in data deletion rights and oversight of CCMS providers. 
• The NSW Department of Education says participation is optional and that CCMS companies must comply with federal and state privacy laws, but critics argue the safeguards are insufficient for protecting vulnerable children’s data. 

Wearable devices/Apps

• LiverRight will deploy Contactless Remote Patient Monitoring in its 2026 telemedicine visits, using the video‑call camera to capture real‑time heart rate, breathing rate, blood pressure and other vitals without any home devices. 
• The platform features a Jaundice Classifier™ that automatically assesses skin and eye hue to identify bilirubin buildup, enabling early detection of liver disease during the same virtual appointment. 
• Powered by Wise AI, a Harvard‑MIT‑incubated startup founded by Annanya Panagala and Mateusz Firlej, the solution serves adult liver‑disease patients in all 50 states, covering HBV, HCV, MASLD/MASH and ALD. 
• By eliminating Bluetooth cuffs, cellular data plans and patient‑owned wearables, the contactless RPM model cuts monitoring costs and streamlines workflow for providers and patients alike. 

CES 2026


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