Smart pills for smart health
The Internet-of-Ingestible-Things hackathon™
As co-founder of Enteromics and PhD in Cyber-biosecurity, I launch the very first Internet-of-Ingestible-Things™ Hackathon as a series of workshops bringing together experts from cybersecurity with medical device regulatory bodies and makers, to help design security for the new generation “Ingestible-Things” or secure smart gut-sensing pills.
Now one year in, the Covid19 pandemic has accelerated the technological transformation of healthcare. The increased need for telemedicine, at-home testing kits and remote-patient monitoring has reached its all-time high, bringing the Internet-of-Medical-Things (IoMT) to the forefront — a cross-breed of medical devices and consumer health products such as wearables.
We can see the shift into this space, as Samsung and Fitbit catch up with Apple (2018, 2020) and receive FDA clearance for their electrocardiogram (EKG) app to track heart rhythm and flag signs of atrial fibrillation; turning everyday trackers and wearables into medical devices.
The data generated from the apps and devices can in itself be considered a medical device, so-called digital biomarkers. Digital biomarkers are combined data from multiple sources (sensors and/or devices) that allow for clinical-grade decision making within healthcare and have been largely enabled by Smartphones.
For example, digital biomarkers are currently in clinical trials for patients with neurological conditions such as Parkinson’s, where there is a great unmet need for non-invasive biomarkers. Roche conducted a 6-month to find significantly different signatures of gait and movement in patients from healthy subjects recorded by carrying a smartphone during the day.
The integration of digital biomarkers and IoMT devices that indicate reliable, and clinically meaningful, phenotypic data, becomes important when thinking about the Covid19 pandemic and lockdown, where patients of chronic disease such as inflammatory bowel disease may have been left untreated with their conditions worsened — increasing the likelihood of for example, emergency surgery, without the use of a monitoring device.
Now, rather than a wearable and health app, what happens if you have an Ingestible?
You don’t have to imagine too hard as capsule technology has been in the market since the mid-1900’s and you may have recently read about the latest at-home care trend for bowel cancer screening capsules as the NHS endorses PillCam, literally a camera-in-a-pill, for patients to swallow instead of standard (and extremely uncomfortable) endoscopy.
Now ignoring the fact that these tiny camera capsules are two decades old, it is a sneak peek to an upcoming norm: the Ingestible Things or smart gut-sensing pills.
From ingestible sensors that remind you whether you have taken your medicine to ingestible thermometer pills that allow trainers to monitor their athletes’ core body temperature in real time during field play or practice.
Why the Ingestible Things™?
The Ancient Greeks believed that “All disease begins in the gut” and there is an increasing body of evidence to support this. Poor gut health has been linked to obesity, cancer and mental ill health, but we have been limited to current methods, which are reactive, highly invasive and require hospitalization.
Finally, we have the technology necessary to access the gut microbiome directly and, through doing so, we can understand our health in a way that has never previously been possible. By analysing and enriching our gut microbiome, we are able to influence the fundamentals of our health.
However, despite the impalpable benefits in personalised medicine, these devices do not come without their own challenges. As we live in an increasingly health-centred world, health data, is becoming more valuable and vulnerable as it is targeted for exploitation. NHS WannaCry ransomware attack (2017), Medtronic’s hacked pacemaker (2013) and the recently hostile state actors targeting universities working on vaccine development are just a couple of examples of these challenges.
As a result you may have also heard that medical device regulation is undergoing changes, with the aim to improve the standards and scrutiny of medical devices with for example, the UK Medicines and Medical Devices Bill 2019–21 currently going through Parliament and the new EU Medical Devices Regulation (EU) 2017/745 underway. It remains unclear however, what the security implications of connected IoMT devices of Ingestible Things will incur to wider-scale health networks and consumer markets.
With all this in mind, what I want to see in a post-Covid world is Responsible health tech and a “bio-savvy” public.
I’d like to see responsible health tech through a prioritization of cyber-biosecurity at the design stage of medical device development. At the same time, I would like to see a more “bio-savvy” public that is informed and demands for secure solutions.
What are the privacy and legal implications of the Ingestible Things™?
Ingestible things™ devices are internet-connected and the data generated from them may include photos, videos and digital biomarkers. Understanding how to navigate potential privacy and security issues of the devices and information contained is vital in designing security in. Additionally, the standardization of digital biomarkers generated by the ingestible things devices is also needed.
How does your microbial signature effect biocrimes?
Our DNA, which you may consider your identity, is actually only 0.01% different between individuals. In comparison, our microbial signature or the ecosystem of microorganisms that reside in the human gastrointestinal tract commonly referred to as the gut microbiome, is 90% unique to an individual.
Microbial signatures characterise an individual with more information than just DNA to include diet, health status, age, and geography. The analysis of a gut sample can reveal whether an individual resides in or outside the city, if he/she co-habilitates with animals and recent research suggests that it can be linked to anti-social behaviour (such as Attention Deficit Hyperactivity Disorder) through the bi-directional signalling of the gut-brain axis.
Knowing that we can uniquely identify >80% of individuals from their microbial signatures up to 1 year later, we begin to question how does this effect biocrimes?
The Internet-of-Ingestible-Things™ Hackathon
As opposed to the traditional development of medical devices, where security is applied retrospectively as a compliance check, the Internet-of-Ingestible-Things™ Hackathon serves as a proof-of-concept to proactively think about security at the design stage of the product lifecycle. Rather than “breaking things” to find security vulnerabilities (typically referred to as penetration testing), the inverse mentality is applied to design in security during the ideation stage of the Ingestible Things device.
By partnering with the global non-profit Biohacking Village, the MedTech start-up Enteromics, the Institute of Making and the Institute of Healthcare Engineering, we bring together hackers, medical device regulators and patients in a series of workshops to help design new secure smart gut-sensing pills.
Our speakers include amazing individuals with experience in working in pioneering companies such as Viome, Thermo Fisher Scientific and Walgreens Boots Alliance. Our Judging panel includes experts from Microsoft and OpenAI.
Join me in the Internet-of-Ingestible-Things™ hackathon with a mission to develop responsible health tech for a more “bio-savvy” public that is informed and demands for secure solutions. Learn about and design the new secure smart gut-sensing pills for chance to win £1000 cash prize sponsored by the Dawes Centre for Future crime.