From Projects to Practice: Why the i2X Special Interest Group (SIG) Matters for EHDS Implementation 

From Interoperability to Implementation: How i2X Is Shaping the European Health Data Space 

From Alignment to Acceleration: How i2X and Xt-EHR Collaboration Supports the Next Phase of EHDS Implementation

From Alignment to Co-Creation: How the i2X Annual Meeting Shapes the Next Phase of EHDS Implementation. 

From Testing to Real-World Readiness: i2X at Plugathon and Connectathon

i2X Charts the Path to EEHRxF Implementation in Athens, Brussels and beyond  

Call for Interest: Join the i2X External Advisory Board

Tecnología con impacto: aumentar la capacidad clínica de los equipos de salud

UpHill obtiene la certificación del Esquema Nacional de Seguridad

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UpHill enables health teams to improve outcomes and streamline care by applying evidence-based knowledge through stepwise clinical pathways.

UpHill Health

UpHill has officially certified its software as a Class IIa medical device

, marking a significant milestone in healthcare technology. 

This achievement places UpHill among the first European software companies to obtain this certification

, reinforcing our leadership in care orchestration and automation fields. Over the past two years, the company has undergone an extensive evaluation process, led by independent international auditors, to ensure compliance with the highest industry standards.

Achieving Class IIa certification is a testament to UpHill’s commitment to delivering safe, reliable, and high-performance technology. The process represented not only a significant financial investment - approximately half a million euros - but also a major effort from the entire team. The certification reflects the company's vision and ongoing commitment to aligning with the highest regulatory standards, reinforcing patient safety and clinical excellence.

, co-founder and CEO of UpHill, emphasizes the significance of this certification:

Class I vs. Class IIa: Understanding the Distinction

In the European Union, medical devices are classified based on the level of risk they pose and the complexity of their function. As software becomes an integral part of modern healthcare, regulatory frameworks now recognize certain digital solutions as medical devices. However, not all software certifications are equal. While many companies opt for Class I certification due to its simpler process, UpHill took the extra step to achieve Class IIa, which involves a much more rigorous evaluation. Here’s what sets our software apart:

2. Complexity and Clinical Impact of Software Features

6. Clinical Validation & Evidence Requirements

8. User Documentation & Safety Information

What Does This Certification Mean for Hospitals?

For hospitals choosing a care orchestration solution, Class IIa certification serves as a crucial decision-making factor, as it guarantees that healthcare providers are investing in cutting-edge technology, independently validated, and designed to ensure maximum patient safety and operational efficiency.

By securing Class IIa certification, UpHill has set a new standard in healthcare software, offering a level of credibility and robustness that few competitors can match. This milestone not only validates UpHill’s technology but also reassures healthcare providers that they are implementing a solution built on the highest safety and quality standards.

UpHill Achieves European Class IIa Medical Device Certification

The imbalance affecting today’s healthcare systems is well known: population needs are growing exponentially, while the capacity to respond remains linear. In this context of limited resources - and with an ever-increasing number of strong clinical guidelines - 

there’s a pressing need to allocate higher-value tasks more intelligently to healthcare professionals

. As such, discussions about the potential of technology for a healthier, more efficient, and more advanced future are only meaningful if the foundation of care delivery is also transformed, f

reeing doctors, nurses, and other professionals to focus on high-value, high-impact tasks

In this article, we specifically focus on optimizing pre-anesthesia assessments. To address the core question, we explore which lower-value tasks can be streamlined or automated.

The problem: inadequate preoperative workup is leading to surgery cancellations but there isn’t a standardized approach to doing it

 are due to inadequate preoperative workup

, and it is well established that preoperative clinics reduce the risk of such cancellations and delays. However, there isn’t a standardized approach to do it.

Likewise, there is currently no standard protocol for determining which patients have Pre-Anesthetic Medical Evaluations (PAMEs),

 as the decision often varies depending on the surgical provider. In some practices, only high-risk patients are referred for a PAME, while others require all patients to complete one. For young, healthy, asymptomatic individuals, these evaluations rarely result in changes to medication or the need for pre-operative testing. Evidence suggests routine laboratory screening tests seldom influence surgical management or improve clinical outcomes. Furthermore, the anesthesia team often conducts its preanaesthetic assessment before surgery, which can lead to duplicate evaluations.

Recently, the COVID-19 pandemic compelled the healthcare system to adopt new practices and expedite the implementation of others that had been progressing gradually. In 2020, this led to the release of the 

Guidelines: Anesthesia in the Context of the COVID-19 Pandemic

using a standardized questionnaire to screen for symptoms of SARS-CoV-2 infection before any surgery

. If this approach was effective during the pandemic, why not apply it universally to all surgeries?

Using a standardized questionnaire enhances the thoroughness of symptom collection and ensures the reproducibility of medical examinations. It is an effective tool for 

gathering accurate information from many patients

The collected data are easily quantifiable and traceable.

 For such a questionnaire to be effective, it must possess key qualities like acceptability, reliability, and validity. The questions should be formulated to be easily understood by the widest range of patients, free of ambiguity, and based on evidence-validated items.

What’s new? Strong recommendation to use 

telemedicine and standardized questionnaires on the preoperative anesthesia assessment.

A new guideline from the European Society of Anaesthesiology and Intensive Care, published a few weeks ago in the European Journal of Anaesthesiology, recommends:

This is a strong recommendation (1B), meaning it should be followed in most cases, as there is a high level of confidence that the benefits outweigh the risks.

According to the authors, various telemedicine applications have been reported to significantly boost scientific output during the COVID-19 pandemic. Although it doesn't allow for a physical examination, telemedicine enables the collection of information before a patient's admission, helping with the screening and triaging of those with suspected or confirmed infections, as well as assessing the severity and progression of their condition. Additionally, telemedicine can help identify patients who need an in-person preoperative evaluation due to multiple comorbidities.

UpHill’s Perioperative Package: reducing

 surgical wait times, preventing cancellations, and ensuring a safe return home

UpHill is a care orchestration software that seamlessly integrates with existing hospital information systems to automate tasks and fill gaps in care. Our 

 is designed to achieve the following goals:

To achieve this, we focus on three key areas:

A future (closer than it seems) where technology frees healthcare teams from low-value tasks

UpHill is thrilled to see these guidelines published, as they perfectly align with the vision our medical team has for optimizing the perioperative process, which is already being implemented in several healthcare institutions.

By using scientifically validated questionnaires and scores to stratify patients based on their surgical and individual risks, we ensure that everyone receives a pre-anesthesia assessment. At the same time, healthcare teams can focus their valuable time on higher-risk patients. 

This approach clearly separates low-value tasks from high-value ones, leading to more efficient and sustainable healthcare systems.

From the patient’s perspective, the benefits are significant

 Patients can provide information about their condition at a time and place that suits them.

his inclusive approach ensures that everyone is assessed, while also eliminating unnecessary in-person appointments, reducing wait times, and allowing healthcare professionals to focus more on complex cases.

 So, to answer the original question: yes, anesthetize safely.

“To anesthetize, or not to anesthetize?” - that is the question

Broadly speaking, all routinely collected data on patient health - outside of controlled clinical trials - are known as Real-World Data (RWD). 

 When we analyze this RWD, we produce real-world evidence (RWE): 

Real-world data have been widely used in research for purposes like tracking drug safety after release and observing patient disease progression over time. With the rapid expansion of healthcare technology—such as electronic systems, biosensors, and mobile and wearable devices—large amounts of RWD are now collected routinely. This wealth of information has immense potential to improve study design and address previously unmet clinical needs.

But could RWD be doing even more? Are there ways to use this information in real-time to improve care rather than only after studies are complete?

Reflecting on UpHill’s participation in the symposium 

, we take a deep dive into how real-world data could be better aligned with the immediate needs of patients, healthcare professionals, and health systems.

To be clear, the value of RWD in assessing a medical product’s benefits in real-world settings is well-documented. The lack of strict eligibility criteria, the ability to track patient behavior in actual healthcare settings, and the potential to support research on high-risk groups - such as pregnant women and children - make it invaluable, especially for research that randomized controlled trials (RCTs) cannot always accommodate.

However, aren’t these approaches working at two very different paces? While RWD may be more cost-effective than an RCT for assessing, for example, the safety of a drug used in heart failure treatment, could this traditional approach fall short of the real impact that the same data could have on managing disease in real-time? Used effectively in day-to-day practice, couldn’t real-world data create a transformative impact on patient care?

Let’s take a step back to address the critical challenge facing healthcare systems worldwide: 

 - driven by an aging population and rising rates of complex chronic diseases - 

while healthcare capacity, regarding available health professionals, remains largely stagnant

. This widening gap leads to familiar issues: long waiting lists for appointments, delays for surgeries, and overcrowded emergency departments.

In this context, healthcare professionals don’t need an overwhelming influx of data that complicates their work;

 they need precise, relevant data to make informed decisions at the right time

. Health systems don’t need to invest in the latest technology for technology’s sake; 

they need to focus on interventions that have demonstrated potential to improve patient outcomes

. And patients don’t need the newest devices on the market; 

they need a healthcare system that’s available when they need it most.

real-world data proves its value when it can influence the course of care for an individual patient while simultaneously streamlining care delivery on a population-wide scale

This journey-based model, fuelled by real-world data, is uniquely equipped to respond to each individual’s unpredictable disease progression, adapting to meet needs as they arise.

A few years ago, while reflecting on the global response to the COVID-19 pandemic, we observed that the future — and increasingly, the present — 

belongs to hybrid models that blend different types of evidence

. Each of them plays a crucial role: scientific evidence should guide care delivery, serving as a map, while real-world data should drive real-time decisions - much like a GPS, offering real-time guidance based on constantly updated information.

This may sound idealistic, but it’s exactly what 

. Believe it or not, all patients need is a mobile phone.

Disclaimer: This article draws on the presentations by Clara Jasmins and Eduardo Freire Rodrigues at the symposium The Impact of RWE on Clinical Pathways.