Bernd Philipowski

What’s the quickest way to integrate digital health applications into the healthcare system and increase the adoption of digital health solutions?   The simplest answer: monetary compensations, also known as financial reimbursement. In 2019 Germany became the first country in the world to integrate digital health applications (DiGAs) into its statutory healthcare system, with the adoption of the Digital Healthcare Act (DVG). Currently there are 44 applications with permanent and 14 with temporary/provisional approval listed in the DiGA directory. Another 11 applications (DiGAs) had been delisted, mainly because no evidence of a positive healthcare effect could be provided. In 2024, the average price per application prescription was €541, with prices varying significantly, ranging from €119 to €2077 per use. Use was often define as 90 days prescription.   Researchers from the Center for Evidence-Based Healthcare, Faculty of Medicine, Universitätsklinikum Carl Gustav Carus Dresden, University Hospital Dresden, Germany (Khira Sippli; Stefanie Deckert; Jochen Schmitt; Dr. Madlen Scheibe) recently conducted a systematic review of the evidence of positive healthcare effects. Here are their main findings: 👉🏼 The researchers reviewed 23 approval studies for 21 DiGAs  👉🏼 For 21 of the approval studies, the study design was a parallel, two-arm randomized controlled trial 👉🏼 The intervention duration ranged from 1.5 to 12 months, with a mean duration of 3.8 months. 👉🏼 Sample sizes varied widely, with the number of participants ranging from 56 to 1245, with a mean of N = 321 (intervention and control groups combined).  👉🏼 For all 21 studies, there was a significant between group effect at post-assessment. 👉🏼 All outcomes, apart from one, were measured by patient-reported outcome measures (PROMs). 👉🏼 All reported significant medium to large effects, but risk of bias was high, raising concerns about the robustness of the evidence supporting efficacy This systematic review highlights that the digital health application approval process exhibit potential for methodological improvement and should be closely monitored.

52

4 Kommentare

A 1979 IBM slide warned: “A computer can never be held accountable; therefore a computer must never make a management decision.” Forty-six years later, the sentence still stands valid as heart of AI in healthcare: machines can inform, but humans must own the consequences. As we prepare for the WHX Tech – EHS AI Summit, we’re convening an in-depth conversation on governance —how we translate principles into operating discipline, clear accountability, risk classification, human-in-the-loop controls, auditability, and post-deployment monitoring. Why now? 
• The WHO’s latest guidance on large multimodal models calls for robust oversight across the AI lifecycle—policy, procurement, deployment, and evaluation. (World Health Organization)
• The EU AI Act introduces risk-based obligations for high-risk systems, including continuous risk management—highly relevant to clinical decision support and SaMD. (Digital Strategy, Artificial Intelligence Act)
• The U.S. FDA’s PCCP framework is reshaping how AI-enabled devices can learn safely after approval—aligning iteration with patient safety. (U.S. Food and Drug Administration)
• Here in the UAE, our AI Strategy 2031 anchors innovation to national priorities, including health—making governance a strategic advantage, not a checkbox. (Artificial Intelligence Office, UAE) At the summit, we’ll unpack conversations on practical tooling , case studies, model inventories, change-control management , validation pathways and beyond —so AI augments clinicians without displacing accountability. Watch this space for speaker reveals, the governance checklist we’ll publish, and the questions we’ll be putting to regulators, clinicians, and industry leaders. #AI #Governance #ResponsibleAI #HealthcareInnovation #DigitalHealth #AIinHealthcare #AITrust #FutureOfHealthcare #EthicalAI #ClinicalAI #HealthTech #UAEAI #WHXTech #EHSAISummit #AI2031 #whxtech #sundayseries

120

4 Kommentare

Very special evening! Enjoyed a great chat with Dr Rowland Illing, Global CMO of AWS, Jens Dommel, Head of EMEA and Adrianna Górska, Manager Public Sector at Amazon Web Services (AWS) to discuss how recent high tech developments are shaping the present and future of the healthcare sector. Healthspan science, which focuses on innovations that target the biological aging process and contribute to healthy longevity, has the potential to point us in the right direction to support human health and well-being. The consensus is clear: there is increasing momentum in healthspan science. Several key areas that need acceleration are identified, including fundamental research, generating and connecting human data, using biomarkers as surrogate endpoints, and fostering collaborations for translational development. #healthspan, #genomics, #imiging, #mulitomics, #generative #AI, #innovation, #medtech #cell #therapies, #regenerative #medicine, #precisionmedicine, #whxtech

129

1 Kommentar