Where the Rubber Meets the Road for the next Frontier in Wellness Management and Healthcare Solutions:
Today more than ever people are taking control over their own health and wellness by collecting, recording, and analyzing their health data. Whether this is by checking the number of steps you’ve taken today via your Fitbit or through an App on your phone such as Move. Humanity is taking steps beyond just tracking their fitness and activity levels as well. Sleep quality and duration, dietary habits, resting and activity level heart rates, as well as direct to consumer genetic testing, along with direct to consumer microbiome companies, such as the Silicon Valley-based 23 and Me and Ubiome (as well as the Colorado-based The BioCollective) respectively are all seeing surges in their sales via increased consumer demand.
With this renaissance and surge of the “empowered patient” via data-driven decision making comes the honor of ensuring that these data are valid, reliable, and that we can aggregate and make sense of this data (as data collected and data available is only as good as the systems in place to make sense of them).
In fact, even the FDA is taking notice of this patient-centered charge.and has set forth guidelines as of 2015 regarding classification of low-risk devices and wellness applications as well as guidelines on direct-to-consumer testing, granting 23 and Me the ability to provide consumers disease risk which informs them about the likelihood of developing certain conditions based on their genetic profile. [Note: 23 and Me only provides data on single-nucleotide polymorphisms (SNPs) which are not the most sensitive or predictive genetic variables, as next generation sequencing (NGS) is the preferred diagnostic tool for clinicians].
It is significant to note that most chronic disease conditions are believed to be a result of genes, environmental exposures, lifestyle choices, and other potentially modifiable risk factors which could increase or decrease the likelihood of developing a disease. The fact that we as humans may be able to take charge of our own health, modify expression of certain genes, control our activity and fitness levels, as well as what we eat and how we live our lives to “control our own destiny” is something that is intriguing and exciting to people which empowers us to try and minimize our disease risks via capturing and utilizing data to make decisions about how we live our lives.
But what does this mean for physicians and other healthcare practitioners? Does an empowered and seemingly informed patient help things or does it challenge the authority of the practitioners that are our healers and guardians that aid in ensuring our health is improved, managed, or controlled via medical interventions and consultations about how we should be living our lives? Perhaps the answer lies somewhere in the middle and there could be ways to bridge the gaps to ensure that practitioners and their treated or managed population of clients are both empowered and equipped to make sense of the data that is presented to both parties.
The logical steps for validation of such “gap stoppers” so to speak, with low-risk medical devices being integrated with patient and practitioner facing applications, is through the clinical trials process. This is why our company, Aces Health, decided to focus primarily on the integration of our software solutions through the clinical trials environment.
So who is Aces Health and what do we do?
Aces Health develops innovative technology solutions to improve the clinical research process, monitor drug/device lifecycle management, and maintain regulatory oversight via a bring your own device (BYOD) mobile application. The Aces platform is centered around robust, intelligent data collection and subsequent analysis by integrating with hundreds of medical devices and biosensors, and is interoperable with almost all other clinical research technology solutions. By leveraging Natural Language Processing (NLP) and machine learning, the Aces platform delivers a detailed and personalized level of subject and site staff engagement that drives higher adherence, retention, and compliance metrics. The Aces platform also provides high-level oversight for CROs and sponsors for increased visibility across various studies, sites, and third parties involved in the research.
By focusing on bridging the gaps and improving the quality, validity, reliability, and importantly the usability of the data that is available to us and aggregating and making sense of this data in a central repository, the future looks bright for citizens of science, technology, and health to be able to leverage our own data, empower our providers, and advance healthcare into the digital age through a revolutionary patient-centric mobile approach.
By John Slattery, Director of Research and Innovation, Aces Health, Inc.