The Growing Need for Smarter Healthcare Solutions ​

As life expectancy increases, so does the prevalence of chronic conditions like cardiovascular diseases, diabetes, dementia, and respiratory illnesses. By 2040, nearly 20% of adults in England are forecasted to have a significant illness, marking a 37% increase from 2019. This underscores the need for innovative, accurate, and efficient care models that prioritize prevention, earlier interventions, and long-term cost-effective management in dispersed home and care settings. Unexpected hospital visits being a major drain on hospital resources. For example: 

  • Preventable and manageable respiratory problems currently account for 13% of emergency admissions in England, with 1.7 million hospital admissions annually recorded.  
  • Hypertension prevalence is rising with age: 9% (16–44), 35% (45–64), and 60% (65+) and can be effectively monitored and managed from the comfort of home to help prevent escalation and emergency visits.  
  • Diabetes currently affects 7% of individuals aged 16–44, but increases to 25% for those aged 65+. ​Many smart solutions help monitor conditions and help provide advice and interventions.  

Virtual Wards: Revolutionising Hospital Care Delivery

Virtual wards and HaH schemes help ease the strain on primary and secondary care services by replicating hospital-level care in patients’ homes. Reducing hospital admissions and freeing up resources. They also allow clinicians to effectively manage and provide access to more patients. Pilots of these programs have proven effective in managing acute and chronic conditions while enhancing patient comfort and outcomes. For example: 

  • Between September 2023 and January 2024, the Buckinghamshire, Oxfordshire, and Berkshire West ICS provided 500 adult and 12 paediatric virtual ward beds, saving 46,685 bed days for adults.  
  • Implementation of virtual wards in the South East of England reduced emergency admissions by 73% for adults and 85% for children, with ambulance journeys decreasing by 69%.  
  • By January 2025, England had created a capacity of 12,627 virtual ward beds, treating 10,162 patients with an 80.5% occupancy rate.  
  • A HaH scheme has been running in Barcelona since 2021. The pathologies most often treated by a multi-disciplinary team being, infectious diseases, acute chronic diseases, post-surgical pathology, and acute psychiatric pathology. In 2023, the scheme treated 2,424 patients. 

IoMT: The Future of Connected Medical Healthcare

While HaH schemes mix dedicated healthcare teams with the use of technology, they are increasingly reliant on remote monitoring systems. For example, what is now termed The Internet of Medical Things (IoMT) integrates devices such as smart glucose monitors, wearable trackers, and connected cardiac monitors to enable real-time health monitoring and personalized care. The IoMT is projected to revolutionize healthcare delivery, with the global market expected to grow from £152.87 billion in 2022 to £561.82 billion by the early 2030s. For example: 

  • 64% of US patients currently use IoMT devices like fitness trackers and health monitors for self-monitoring, but IoMT devices are now also increasingly expected to be used for more formal and healthcare based remote patient monitoring. With 30 million US patients predicted to be using these tools in the not-too-distant future.  

Regulatory and Governance Frameworks ​

Ensuring the safety and effectiveness of IoMT and medical devices that goes beyond self-monitoring, however, requires adherence to strict regulations. In the UK, the Medicines and Medical Devices Act 2021, Medical Devices Regulations 2002 (UK MDR 2002), and Medical and Healthcare product Regulatory Agency (MHRA) classifications guide the trial, approval, and monitoring of medical devices. The Medical Device Regulation (MDR) 2017/745 also covers medical and software devices marketed in the EU. The variety of regulations seeking to ensure their safety, effectiveness, and quality: 

  • Definition: A medical device being any instrument, software, or material intended for diagnosing, monitoring, or treating medical conditions. 
  • Devices being classified into four risk categories: Class I: Low risk, Class IIa: Medium risk, Class IIb: Higher medium risk, Class III: High risk; and are all subject to specific MHRA guidelines and ISO standards .
  • Manufacturers and system providers must therefore provide technical documentation, risk assessments, and clinical data supporting their intended use.   
  • While low-risk devices are subject to self-conformity declarations, medium to high-risk category devices must also undergo additional conformity assessments by notified bodies.    
  • Clear labelling and usage instructions are mandatory to ensure safe operation and proper use of medical devices.   
  • Post-market surveillance and cybersecurity standards are also critical for maintaining device safety post-approval and post-deployment and to monitor real-world performance.   
  • Cybersecurity and Data Protection: Devices must comply with UK and EU GDPR and cybersecurity standards to protect patient data.   

Software and AI as Medical Devices

  • Many systems are increasingly looking to use and leverage software and AI for speeding up analysis and increasingly accuracy. 
  • Software as a Medical Device (SaMD) categories are therefore also important and as an example, can cover platforms and smartphone apps. Software performing medical functions (e.g., diagnostics, treatment management) are therefore also regulated as medical devices and can form part of a system that is purely software or includes hardware.   

In the UK: 

  • The Evidence Standards Framework for Digital Health Technologies (2019) focusses on apps, software, and online platforms.  
  • The Software and AI as a Medical Device Change Programme (2021) particularly addresses cybersecurity, data privacy, and post-market evaluations of these technologies.   
  • The Regulation of AI as a Medical Device (2022) framework emphasizes patient involvement and communication between regulators, manufacturers, and users. 

In the EU: 

  • The EU combines soft-law guidelines with hard legislative frameworks. The EU is also moving towards a more legislative approach with binding rules, emphasizing standardisation and harmonisation across member states. 
  • Key regulations include the European Medical Device Regulation (2021) which deals with risk-based classifications for Software as a Medical Device (SaMD).  The EU AI Act (Proposed in 2021) is also a harmonized legal framework with strict specific requirements for high-risk AI systems.   

Telecare: Enhancing Independence and Safety

Telecare differs from the telehealth or telemedicine by using technology like sensors, alarms, and wearable devices to monitor the welfare of vulnerable individuals remotely (not medically). Enabling them to live independently while ensuring a high degree of safety. Up to 9.7m people in the EU and 2 million people in the UK now use telecare services and devices, including personal alarms and fall detection systems. The need for telecare devices and systems are also growing with an aging population and creating opportunities to create combined healthcare and telecare schemes. For example: 

  • As well as creating a safety net at home, telecare services are also vital for the 441,479 residents in UK care homes, with 37% now self-funding their care.  

As with smart healthcare, HaH and virtual ward systems, telecare systems are also becoming more advanced. Adopting smart IoT technologies that help with a broader range of monitoring and integration with specialist devices such as passive radar for fall detection. Telecare systems are also responding to the availability of AI to analyse and learn routines and therefore spot anomalies. Again, the ethical frameworks around privacy and knowing when to act or advise or intervene being critical. 

The Benefits and Challenges of Advanced IoMT systems

IoMT and medical device technologies offer numerous benefits, including improved patient outcomes, reduced hospital admissions, and enhanced resource efficiency. However, challenges like ethical concerns, regulatory compliance, and the need for robust cybersecurity must be addressed prior to market delivery (Ramirez, 2024). For example: 

  • Robust and secure connectivity is critical to allow patients to send data and receive updates on their treatment plans without needing to always visit clinics or hospitals physically. 
  • AI and machine learning being increasingly used to analyse health data and detect potential issues (Singh & Kaunert, 2025). 
  • IoMT devices not only help virtual wards and HaH schemes deliver medical data and remote consultations, but they can also help automate operational tasks such as in-field asset tracking and workflow organisation. Improving cost of healthcare delivery, accessibility and creating cost efficiencies via new practices.  

Conclusions

The integration of IoMT, telecare, and virtual wards is transforming healthcare delivery, offering innovative solutions to meet the growing demand for patient-centred care. By leveraging technology, healthcare systems can enhance accessibility, efficiency, and outcomes, paving the way for a smarter, more sustainable and healthier future (Razdan, et al., 2022). 

About CSL Group

The CSL Group is a leading provider of advanced life-critical connectivity technologies for Health, Telecare and IoMT device providers and systems that rely on advanced, robust and fully resilient, real-time communication systems. Please contact us to learn more about our unique technologies that ensure real-time resilience and security for IoMT and telecare devices.