Ageing populations and the growing prevalence of chronic diseases are pushing up healthcare costs and placing more and more pressure on cash-strapped health systems. Anything that helps health services find ways to reduce these costs and increase the efficiency and quality of care is going to be welcome therefore.
Connected health is one such enabler, according to David Pettigrew of Sagentia, which provides technology advisory and R&D consultancy services to the medical sector among others. Pettigrew describes connected health as the use of technology to provide healthcare at a distance and improve speed of response.
Connected health goes further than previous delivery models such as telehealth and telemedicine by combining smart sensing technology, fixed and wireless networks and cloud computing. Sophisticated algorithms and centralised storage systems are then used to mine, analyse and make sense of the ‘big data’ being collected.
Keeping people out of hospital in the first place is of prime importance to ease the pressure on overburdened healthcare systems, so monitoring and prevention are among the most promising areas for connected health in meeting this challenge.
‘It’s about reducing admission and readmission rates - the less time anyone is in hospital the better for all concerned,’ says Pettigrew. He adds that it is this ability to provide real-time data management and decision support that distinguishes connected health: a bed-side monitor linked to a nursing station that alerts nurses to a critical event, to take one simple example.
A key component of connected health is the ability to monitor patients in non-clinical settings between appointments. ‘Clinical indicators can be very transient,’ observes Pettigrew. ‘Someone with arrhythmia can turn up to a hospital and measure normal; it’s the same with asthma.
‘But by collecting data from non-standard settings outside of the clinical environment you can detect passive, but rare events that have a strong clinical significance. So, by monitoring people outside of hospital we can detect health problems early.’
Pettigrew says that the devices need to monitor users without interfering with their daily routines or they won’t use them and the resulting data needs to be presented in a way that it is understandable by the user.
‘Ensuring that the data is presented clearly and provides actionable information is key,’ says Pettigrew. ‘We need to consider what information is presented, how it is presented and who it is presented to depending on the context. For example, where there is low risk more responsibility might be given to the patient rather than the clinician.
‘In other cases it might be more appropriate to present the data to the clinician first. There will be trade-offs like this in many situations. It is all very new and very much depends on the application, what the risk profile is and what people will accept.’
‘Getting clear and actionable information is also important when looking at data from across a population as this can then be used to really help improve products and services’ adds Pettigrew.
Smart health devices
In terms of where connected health has reached, blood glucose monitoring is in the forefront and it is evolving incredibly quickly, according to Pettigrew, who says there are a lot of monitors and insulin pumps on the market already.
For example, Senseonics, based in Maryland, USA, has developed a novel implantable continuous glucose monitoring system, which consists of an implanted sensor based on a fluorescent glucose-indicating polymer, and a receiver worn on the skin that provides power to the sensor. The system receives a signal and processes patient data using embedded software.
‘Ensuring underlying health issues are properly addressed and encouraging lifestyle improvements drives reductions in both the number of people visiting healthcare providers and repeat visits. Technology is proving a key enabler in realising these aims. Breakthroughs like Senseonics’ could have a really significant impact on patient care’, says Pettigrew
Proteus Digital Health in California is another example. The team there are working on digital medicines where each pill will contain a tiny sensor that can communicate, via a digital health feedback system, vital information about the patients’ medication-taking behaviours and how their bodies are responding to the treatment.
The wireless signal is activated by the patient’s stomach acid, so monitoring staff can tell if the pill has been taken or not; they won’t get the signal until the stomach acid hits the pill and a signal is sent to a patch on the body. The solution could be used to monitor drug compliance programmes, for example.
Arrhythmia detection is another key area currently being explored. For example, California-based AliveCor’s heart monitor device measures electrical impulses of the heart (ECG), as well as heart rate. The monitor attaches to any supported iOS or Android device. The device attaches to the mobile phone, then wirelessly communicates with the AliveECG app downloaded from Apple App Store or Google Play on the mobile. The user creates an account and can then record their ECGs.
LifeWatch, which operates out of Switzerland and the USA, provides a number of remote arrhythmia monitoring devices and a home sleep testing service for the diagnosis of obstructive sleep apnoea, among its products.
Singapore’s ePhone International also has a pocket ECG monitoring device, the EPI Mini, as well as the EPI Life mobile phone with ECG and other health monitoring functions such as blood pressure, blood glucose and cholesterol. These are linked to ePhone’s health concierge services, which notifies users of any abnormal readings that might require investigation.
A further example is the Endotronix system, which uses an implanted sensor to communicate pressure from inside the patient’s heart to a smartphone app via a transmitter. The system captures internal heart pressure data and communicates it securely from a remote location to the patient’s care team.
‘There are a lot of things like this in development,’ says Pettigrew, ‘but there are still uncertainties over regulation for these devices. If you develop a medical device you own all the hardware and software, so you know the risks and you control it. But with a smartphone medical app, you don’t essentially control either, so how do you demonstrate to regulatory bodies that the smartphone behaves in ways that meet the rules?’
In the USA, the most advanced connected health market, the US Food and Drugs Administration (FDA) has issued formal guidelines for medical smartphone apps. ‘Generally for medical device companies the hardest part is demonstrating the system is safe enough to gain FDA approval,’ Pettigrew comments. One of Sagentia’s key offerings is engineering novel sensors and building systems around them to manage the data generated. Part of that is developing the medically regulated apps that are integrated into those systems.
Pettigrew adds that the success of connected health devices is dependent on user acceptance. One reason smartphone medical apps are an easy route to acceptance is that consumers are already familiar with them. The drawback is rapid changes in smartphone hardware and operating systems may affect the functionality of the apps and this is a cause for concern for healthcare manufacturers and regulators.
‘There are also a number of things you have to think about in terms of wireless or wired connectivity for connected health apps and their respective power requirements and data rates,’ says Pettigrew. ‘Wi-Fi and broadband have the advantage of enabling the healthcare device to be connected to existing networks, so that keeps costs down. The disadvantage is that they are power hungry and that limits the use of the device if it is battery operated.
‘In these instances Bluetooth Low Energy (Bluetooth Smart) is often used as a solution as it has a low power consumption, but the trade off is that means a low data rate. There are ways around this and we work on a lot of projects to try and circumvent that trade-off by, for example, using embedding processes within the portable device so that less data is being exchanged.’
Yet another challenge is trying to ensure all the different sensors and devices can talk to each other, so the data can be aggregated properly. This is vitally important and that means there needs to be standardisation and product certification to ensure interoperability.
The Continua Health Alliance in the USA is helping to spearhead this and has made considerable progress in developing a system of interoperable personal connected health solutions, according to Pettigrew, but there is some way to go yet.
The US has led the way with connected health as the pressure there to cut the cost of healthcare programmes is immense, as medical insurers foot much of the bill – now partly subsidised under ‘ObamaCare’. But Pettigrew adds that the regulatory environment in the US remains highly uncertain.
Europe has been slower to adopt connected health solutions, but commentators believe that the market here is ready to make the move from small scale pilots to mass market implementation.
‘There is a lot of excitement around eHealth, but people are just getting to grips with the architecture, so we are only at the start of this,’ cautions Pettigrew. ‘Many of these developments will be driven by real tangible clinical benefits. These things involve big infrastructure changes, which need to be addressed. But if we can demonstrate the clinical benefits and it is economically viable, then the investment will be worth it,’ he argues.
Box: Smart inhalers
A good illustration of how connected health is developing is an intelligent inhaler concept developed by Sagentia for asthma patients.
It is well documented that patients typically only take between 30% and 50% of medications prescribed. The problem with patients either improperly or not taking their medication is that it can lead to increased morbidity, mortality, and treatment costs.
This in turn creates significant challenges for pharmaceutical companies, healthcare professionals and, especially pertinent in countries like the USA, the organisations paying for the treatment (i.e. medical insurance companies).
The concept uses a novel acoustic detection technology, together with a cloud based server and mobile app, to monitor and interpret whether a patient is administering their dose properly. The system could both warn the patient that a dose was taken incorrectly and coach them to improve their technique, as well as providing their doctor with a historic record of treatment adherence to determine the context of an asthma attack and options for improved treatment going forward.
Pettigrew says: ‘The concept device measures the flow rate of the medicine in the inhaler, so carers can see whether patients are inhaling correctly and are getting the right dosage at the right time.’
The core technology has been used in a number of clinical trials, but Pettigrew says the next step for this application is to start getting information from users in the home. ‘You can imagine a scenario where a user goes to see the clinician and says my peak flow is down and asthma is getting worse,’ he points out.
‘The clinician can then check the patient is using the inhaler properly. He can log on to cloud-based server, which shows the inhaler monitoring results. It might be that the patient is using the device properly, but as the asthma is worse that would indicate he or she is on the wrong medicine and needs to change it. Alternatively, it may reveal that the patient isn’t using the device properly.’