Vincent Keunen

Medical records and interoperability are major issues in countries around the world. Sometimes departments in the same hospital exchange data incorrectly. Sometimes hospitals in the same country exchange data incorrectly. So, expecting international interoperability seems like a dream to many. But that is what we have achieved as a patient-led start up. For the first time, patients using Andaman7 are collecting their health records from both US and EU-based hospitals, at the same time, in the same software and with them in total control. Health data is normalized in their personal health record (PHR) meaning several exchange protocols, formats and interfaces are used to grab the data and store it in a uniform manner inside their smartphones. Storage of the data in a smartphone is key–not only does the patient have instant access to their data but it is more secure than cloud-based systems and under the patient’s total control. For the patients themselves this represents a huge leap forward in health data empowerment.

Andaman7 were encouraged by the patients’ positive feedback: “Navigating the medical system can be a stressful experience over and above the stress related to your own medical condition. It has been a challenge to keep track of accurate and up-to-date health data which has been scattered across several hospitals, and–in the case of my wife and me–across several countries. With the Andaman7 app, my wife and I were able to gather our health data from hospitals in the US and Belgium and manage it in one app in an organized and intuitive way. It feels right to be in charge of our data to ensure a smooth transition of our medical records from the US to Belgium. In addition, we can share our health records with each other and with our doctors if needed. It can only be hoped this becomes a common option.”

The next step, with patient consent, is to send data back to the hospitals–something Andaman7 is ready for. This innovation has far-reaching implications for the collection of real-world data (RWD) and the forming of real-world evidence (RWE). Andaman7 uses FHIR for inbound and outbound health data exchanges (in addition to other, de facto standards). Internally, they also use a very innovative liquid data model and ‘no protocol API,’ and fully support LOINC and SNOMED for high quality structured data. Properly used, RWD could enable us to reach one of the holy grails of medicine–the right treatment, for the right patient, at the right time.

Empowered international patient data access also has implications for tackling global health inequities. Africa bears the world’s greatest disease incidence and has significant healthcare shortages. Yet it has emerged as a new breeding ground for innovative digital health solutions. Our work with African Sustainable Development Advisors (Afrisda, Inc.) leads us to believe Africa can ‘skip one’ in health digitalization. The framework is already in place–large parts of the continent skipped the landline telecommunication stage and went straight to mobile. Now, there is an opportunity to avoid the step of disjointed, physical healthcare and instead embrace teleconsultations, electronic health records (EHRs) and patient empowerment platforms (PEPs). This could benefit local populations and increase RWD and RWE from diverse populations for global therapy developments. However, to truly seize this opportunity patients must be involved in every stage–from development and process to information access and solutions.

The recent controversy in the UK over the GP Data for Planning and Research program shows what happens when patients do not feel informed about how their data will be used. The initial launch was delayed following a public backlash over a lack of patient involvement and awareness. Now, it has been announced the program will not go ahead until key steps are met. Crucially, they include patient ability to opt out and back in and a trusted research environment. However, it is still only focusing on national interoperability.

To truly seize the opportunities of a global health data revolution we must embrace patient empowerment. International interoperability is a huge step forward to achieving that.

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Embracing patient empowerment in data collection can lead to new standard of care.

Interoperability Cracked as Patients Collect Health Records from Hospitals

The eClinical market is on the rise. Research released in December 2020 estimated it would surpass $16.36b by 2027.

 But what do we understand by ‘eClinical’ and what innovations may this growth lead to and how will the industry make use of them?

eClinical is a term that has evolved over time and in definition, just as the industry has shifted and developed. What may have started as trial automation to streamline particular function areas has expanded, as the number of applications and disruptive technologies increase, bringing with it its own problems of duplication of data and redundancy in process.

As technologies integrate, improved usability is the operative characteristic for an efficient eClinical approach. And this not only to improve productivity, but also increase collaboration to the benefit of all. And central to this new approach is drawing from patients’ experiences and perspectives and developing next generation tools driven by patients.

At the same time, whilst decentralized/mobile trials focus on the patient, new tools to support the clinician, investigator, medical device companies, third party patient services and broader healthcare networks are emerging, to create a more accurate holistic view, and consolidate operations and efficiencies to develop faster therapeutic solutions.

The ultimate endgame is technology that works across all data types, protocols, sources, and formats for research and care coordination across all therapies which can:

So, what new developments are shaping today’s eClinical evolution?

While some have tried with blockchain, there is a lack of fully distributed electronic health records (EHRs) where all participants can contribute–family doctors, specialists, hospitals, nurses, and the patient. There are a number of technical challenges to consider. Who can modify and access data? Is the data valid? What data is from a health professional and what data is from the patient? There are also questions about how EHR can be used for research beyond the obvious use for care.

However, there are solutions which can be utilized to allow EHRs to reach their full potential, such as marking every value in every data field with a unique ID, date-time stamp and source. Every piece of data is therefore uniquely identified and there can never be a ‘data conflict’, even if the data is modified at various places at the same time by multiple actors. This is critical for transparency and traceability. It also means everyone reading the health record will know where the data comes from. This allows data to be graded based on whether it has come from a patient, healthcare professional, consumer grade or medical grade devices or a laboratory system.

Informed consent and having the right processes in place to achieve it, has long been a challenge for clinical research and treatment. Recent guidance suggests the best way to meet the legal requirements of informed consent at treatment level is to develop a consistent practice of involving patients, even if that involvement may occasionally be limited.

 eConsent can help increase this involvement, as well as aiding understanding for clinical trial participants, for a number of reasons. It can be adapted and provided in different formats to meet diverse learning styles and levels of health literacy. eConsent also offers the opportunity to test and reinforce comprehension, widen the patient recruitment process, and reduce drop-out rates. Crucially, when well designed, it allows participants to give feedback quickly and easily on how consent materials could be improved. It must be very simple to use, very clear, with no hidden ‘small print’ and, with GDPR right to be forgotten, it must also enable consent to be removed. However, a scoping review published in May 2020

 identified a need for researchers and commercial software vendors to create a unified approach to truly harness its potential.

The costs of medicines non-adherence, both personal and economic, are well reported. Common reasons for unintentional non-adherence include difficulties recalling or understanding instructions or simply forgetting to take the medication. eClinical offers several solutions to this hugely costly issue. Apps can be used to distribute medicines schedules to all patients, reminders can be sent, and concomitant drugs can be managed using Personal Health Records (PHRs). If consent, data collection (questionnaires) and adherence can all be within the same tool, it can simplify life for the patient and keep them better engaged and informed. Where adherence modules feature in mobile systems, these can also capture intake information to feed a study.

eClinical is about more than just helping patients manage their health and clinical trials. It can also help medical staff on a day-to-day basis. Simple alert systems can give data on biometrics including oxygen saturation, heart rate, respiratory rate, and temperature. Such deep integration between data collection and alerting allows for real time, or near real time alerting, which can be crucial.

There is, however, a need to ensure systems work with, and for, doctors rather than increasing their burden. A 2020 study examining perceived EHR usability as a predictor of task load and burnout among US physicians, found more favorable usability was associated with less workload. Researchers concluded improving EHR usability while decreasing task load has the potential to allow practicing physicians more working memory for medical decision making and patient communication.

 It is therefore vital clinicians are involved in development.

Incorporating PROs into platforms provides access to real-world data which, in the long-term, could have a significant impact on development decisions and improve care. Recent research has found both clinicians and patients find value in electronic real-time symptom reporting.

But to maximize their potential, PEPs should be informed by a full personal health record (PHR) and PROs providing rich data. They must be able to handle multiple types of documents, including lab results, pictures, and specialist reports. For example, one ePRO tool for rheumatoid arthritis includes a sleep tracker, pedometer, the ability to upload pictures, documents, X-rays and lab results and questionnaires.

The ‘data gold rush’ driving eClinical approaches can result in forced data sharing or lack of real comprehension regarding data collection.

By reversing the role completely and enabling patients to be in control of their data, empowering them to contribute to research and to the wider common good, is proving to be a great incentive and generating significant return.

A full personal health record stored on a smartphone, available for use even outside a trial for wider healthcare benefit, puts patient centricity at the next level.

Bridging the gap between research and care

The inclusion of a full PHR into advanced platforms is transforming trials and RWE studies as the range and scale of data is much greater. It is also of a much higher quality when acknowledging that up to 30% of hospital EHR data is wrong

 and easily rectifiable if patients can access and correct this.

Giving each patient a global view and access to all their health data which they can continually collect, share and control will bring a future of cheaper and faster research and more targeted treatments and therapy innovations.

Next generation mobile technologies and applications are revolutionizing the way we think about clinical research. But so much more can be done to better integrate all the relevant stakeholders across the health ecosystem, bringing real eClinical ‘intelligence’ and a holistic approach to clinical research, patient care, and therapeutic innovation.

https://www.precedenceresearch.com/eclinical-solutions-market

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3307558/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7233043/

https://www.eurekalert.org/pub_releases/2020-10/ulcc-cpc103020.php

https://ehrintelligence.com/news/diagnostic-medication-errors-rank-among-most-common-ehr-related-issues

New technological solutions for both patients and HCPs create a well-rounded eClinical approach

Vincent Keunen

Articles

Interoperability Cracked as Patients Collect Health Records from Hospitals

Taking eClinical to the Next Level