At Apple’s much-anticipated Watch launch event in San Francisco yesterday they delivered what was largely a surprise announcement. For months there has been speculation about the Watch and its possible implications and applications for health. Recently these expectations had been diminished by leaked reports of greatly scaled back integrated sensor technology.
Instead, however, Apple announced a new software framework with the ambition to turn the 700 million iPhones and their owners into medical diagnostic tools and possible research participants. ResearchKit is an ‘open-source’ (not sure this makes real sense but I understand what they mean) framework that could enable medical researchers to build or utilise diagnostic applications that tap into the built-in functionality such as microphone, screens and accelerometers on the iPhone, as well as data created from HealthKit integrated applications. The first five apps built with ResearchKit are available today, and they’re built to help tackle Breast cancer, Asthma, Parkinson’s disease, Diabetes and Cardiovascular disease. As someone who is actively designing and building applications in three of these five conditions I am of course very interested in this development. At The EarthWorks we have been looking at many of the challenges at the intersection of mobile health and medical research (outlined on stage by Apple Senior Vice President of Operations Jeff Williams) and here are my initial three areas for optimism with a particular focus on the pharmaceutical industry:
1. It could begin to redefine pharma’s application of real world data; patient reported outcomes and design of phase IV trials
Please note emphasis on the word ‘begin’… This could be an exciting change for pharmaceutical research. Jeff Williams pronounced from the stage his hopes that ResearchKit can help address problems with medical research such as limited patient participation, infrequent data sampling, and one-way communication from the patient to medical professional. Obviously those of us who have spent a career in pharma understand that the major headache for pharma is recruiting for phase II and phase III clinical trials and establishing the efficacy and safety of a drug, something that ResearchKit within current clinical and legal frameworks could never directly impact. However, there has been an acceptance amongst forward thinking pharma research professionals that the explosion in the capacity to gather data from ‘real life’ environments is something under utilised by pharma. This capacity and shortfall is further highlighted by the possibilities and opportunities afforded by the contextual computer that is the ubiquitous smartphone. Current patient reported outcomes projects in pharma are broadly restrictive environments with strictly defined feedback systems restricting the capacity to understand patient outcomes in the real world setting. The acceptance of all the inherent shortfalls and protocol issues is probably superceded by the capacity to build data sets of a massive scale. This could mean that pharma can start to redefine even the phase IV clinical trials that are focused post marketing on a treatment's risks, benefits, and optimal usage.
2. Support the development of clinically relevant applications to improve chronic disease management
Many current applications built by pharma are of very limited clinical relevance and are nothing more than data entry repositories aimed solely at improving ‘adherence’ to medication. I believe strongly that any application that cannot improve clinical outcomes without the medication should be treated with suspicion. This challenge is further compounded by human nature. If you are suffering from a chronic condition any added burden or friction that is added into the daily management will result in people simply not participating. This is why data logging, reminder service interventions are not successful. The example shared from the stage that interested me most was when Jeff Williams detailed the mPower application, which is built to better understand the effects of Parkinson’s’ Disease and was developed in conjunction with the University of Rochester, Xuanwu Hospital at Capital Medical University in Beijing, and Sage Bionetworks. What I would like to see is the capacity to overlay these datasets with other interventions including medication, and also the capacity for contextual real time support. The challenge for mobile health designers is to enable contextual support that offers real value, improved quality of life and clinical outcomes with the least amount of burden placed on the user. Applications that do not do this will harvest little data from users and be of no use in ResearchKit integrated applications. For this reason I hope that it will drive up the quality of mobile health development in pharma as the capacity to add value to the proposition will be much more than a tick-box on a brand plan.
3. Challenge current patient support programme design
Although a cross over with a previous post on designing digital patient support programmes, it would be remiss to not mention the possible implications for patient support design. Engaging and enabling patients participating in support programmes to actively share their attitudinal, behavioural and disease reported outcomes data is a fantastic opportunity for pharma to better understand their medicines and help patients in a real world context.
In conclusion I am excited by what is happening with Apple’s continued commitment to digital health. Of course, they are not able to solve all the issues and there are a number of concerns. For me at this stage I would highlight the declaration that this is ‘open source’. If we define open source as a production and development model that provides universal access to a product's design, and universal redistribution of that design, including subsequent improvements to it by anyone, ResearchKit is blatantly not ‘open’. Apple has complete control over the applications built for their eco-system that are available to the public. However the spirit of enabling this platform for integration with an application that can challenge the best app developers, is an opportunity, and the quality control inherent in the Apple eco-system has its benefits. The other thorny issue is data security and privacy. Apple say simply that the user has complete control of with whom and how your data is shared and for those of us already advising and supporting the management of patient data know that Apple introduced strict rules when it launched health last summer. It is my hunch that people will feel more comfortable within the Apple eco-system but it will be interesting to see how patients respond in the real world and what value exchange they deem acceptable to mitigate the risks. Overall, the announcement yesterday was positive; it is now up to pharma and its partners to utilise the opportunity to its best advantage.