HCIT Experts Blog: Things & Thinks XXIII – Yajur Healthcare
Navigate the complexities of Digital Health: COVID Innovations & EU Medical Device Regulations, where early digital health tools showed mixed results, setting the stage for future healthcare solutions. Understand how the EU’s Medical Device Regulation (MDR) is reshaping the global market, impacting both the UK and Switzerland, while new tech partnerships and funding are driving the dynamic evolution of digital healthcare. Discover the critical need for better data, clinically relevant data, regulatory oversight, and patient-focused solutions. News Directory 3 delivers an insightful viewpoint on these pivotal shifts, like Amazon Care’s pay-per-user model and advancements from providers such as CVS Health and eli Lilly. Explore evolving virtual care platforms. What does the future hold for digital health? Discover what’s next.
Digital Health: COVID Innovations and EU Regulations
Updated June 10, 2025
The rush to implement digital tools during the COVID-19 pandemic yielded mixed results, prompting valuable lessons for future healthcare solutions. Concurrently, regulatory shifts in the EU, particularly the Medical Device Regulation (MDR), are poised to reshape the global landscape for medical devices. Recent partnerships and funding updates further highlight the dynamic nature of digital healthcare.
The effectiveness of digital health interventions during the pandemic varied. Contact tracing apps, for instance, faced scrutiny regarding their accuracy and potential drawbacks, according to a report in The New York Times. Similarly, the use of artificial intelligence in diagnosing chest X-rays raised concerns about data quality and clinical relevance, as noted in Nature Machine Intelligence. A MedCity News survey revealed that nearly half of surveyed health systems used unregulated automated tools during the pandemic.
Thes experiences underscore the need for improved data collection, clinically relevant labels, and consideration of patient perspectives in the design of algorithmic decision-making systems. Experts such as Topol and Obermeyer emphasize that algorithms should not merely replicate the limitations of existing medical practices. Greater regulatory oversight is also essential.
the EU’s Medical Device Regulation (MDR),which aims to enhance the safety profiles of medical devices,has implications for the UK and Switzerland.UK-manufactured devices must comply with the MDR for EU market access. Switzerland faces similar challenges due to the lack of an updated Mutual Recognition agreement. Industry groups in the UK are consulting with the Medicines and Healthcare products Regulatory Agency (MHRA), hoping the UKCA will align more closely with MDR. The MDR imposes obligations on EU importers and distributors, possibly setting a global standard for medical device regulation.
In digital healthcare news, Amazon Care is using a pay-per-user model with Precor, a departure from traditional fixed-cost contracts. Kaiser Permanente and Mayo Clinic are investing $100 million in Medically Home, a hospital-at-home company. The FDA’s rapid approval of antibodies reflects the accelerating pace of drug progress. CVS Health is entering the digitized clinical trial space, while Bigfoot Biomedical received FDA clearance for its insulin-recommending diabetes management system. Eli Lilly has signed compatibility agreements with Roche, Dexcom, Glooko, and myDiabby Healthcare. Telehealth providers Amwell,Verizon,and Doximity have launched new virtual care platforms. Ireland’s Health service Executive (HSE) was recently targeted in a ransomware attack.
What’s next
The digital health sector will likely see continued innovation, increased regulatory scrutiny, and evolving partnerships as stakeholders strive to improve patient outcomes and navigate the changing healthcare landscape.