By Lynn Carroll, Chief of Strategy & Operations at HSBlox and Stephanie Perez, Associate Director at R3
It is an unfortunate but undeniable reality that today’s healthcare industry is plagued by operational inefficiencies, errors, bureaucracy and high administrative costs. While other industries have modernised as the technology available to them has evolved, the healthcare sector continues to play catch-up – and more often than not to the detriment of the patient.
Consider, for a moment, how the consumer experience of personal banking has transformed in recent years. Not so long ago, bank statement reconciliations were needed because of a lack of real-time transparency, leading to visibility after the fact. As the shift to electronic transactions accelerated, reconciliations fell by the wayside and consumers could make informed financial decisions with up-to-the-minute information.
Imagine if a similar technological shift took place in the healthcare industry, empowering participants in clinical trials to permission access to their own medical records or patients with chronic illnesses to become effective managers of their own health. Thanks to innovations in enterprise blockchain technology, this vision is fast becoming a reality, disrupting the current modes of patient data access, accumulation, contribution, exchange and control.
Tackling the data challenge
A recent study of clinical operation leaders from global life sciences companies showed that a staggering 80% of respondents regularly miss trial milestones. The main reason is that in the quest for efficiency and specialisation, pharmaceutical companies have increasingly sought the expertise of contract research organisations (CROs), who carry the responsibility of meeting timelines, as well as quality assurance and data-control requirements. CROs, in turn, look to sample laboratories, logistics partners and specialised healthcare professionals to collect, store and manage samples and data.
This complex network of local and remote systems and data sources to support a typical trial means clinical operation leaders cannot investigate issues in real-time or are unaware of all actions being taken to address data and quality issues. As a result, leaders don’t trust the study metrics or results become outdated. At the same time, although they are inundated with data, leaders frequently rely on antiquated and manually compiled spreadsheets derived from multiple systems, which further reduces their visibility and slows trial progress.
The emergence of blockchain technology offers the healthcare industry a once-in-a-generation opportunity to address these challenges by generating auditability and traceability between stakeholders with a single source of truth that reduces errors and the need for reconciliation. In simple terms, it enables the participants who are privy to the shared facts of a transaction to know with 100% certainty that what one entity sees is what the others also see.
Turning patient data into actionable intelligence
Gaining access to patient medical data can provide tremendous opportunities for clinical research, creating actionable intelligence from the added information. However, patients need the incentive to donate data, and the assurance that it will remain private and secure.
Recruiting patients in the first place is half the challenge. According to a recent Accenture report, only 38% of patients feel knowledgeable about new products coming to market that may benefit their health and less than half of patients feel that their doctors discuss the entire spectrum of therapies. For patients that are successfully recruited, the trial is often stalled because of the challenge of gaining patient consent.
Blockchain’s ability to offer a secure, anonymous database means trial and patient information can coexist in one network. As a result, patients can connect directly with trials for which they qualify. Simply by giving the patient more visibility, the trial recruitment challenge is overcome. And by offering a shared, centralised database for consent forms, the patient consent challenge is also overcome.
A blockchain platform, properly designed, can enable additional stakeholders to be continuously added as network participants, allowing cross-trial data sharing and integration of the patient to the point where they can permission access to their medical records.
With patients as stakeholder participants, smart contracts can then govern the permissioned sharing of their medical data, as well as an immutable record of their consent. As Deloitte has noted, “a solution which enforces rules, privacy, and regulations in a mutually agreed upon manner, resulting in a smart contract between patient and healthcare stakeholders can be an important enabler to clinical research.”
It is clear, therefore, that acceleration of clinical trials and regulatory approvals can be enabled by blockchain, benefiting trial sponsors, trial sites, researchers, clinicians, and, most importantly, patients. The identification of potential participants, their consent and enrollment and the aggregation of their data can be faster and more efficient with permissioned access approaches on a blockchain platform.
Enabling patient self-management
Along with further integration and transparency in the clinical trials space, blockchain has the potential to empower patients with chronic illnesses to become effective managers of their own health.
To become stewards of their own well-being, real-time access to and exchange of information are critical components of chronic disease management, especially as home-based caregivers and other community resources are increasingly involved in patient care. The current environment is highly fragmented, with both patients and caregivers requiring more control. Blockchain can achieve this by enabling both parties to aggregate information for themselves and share it with other stakeholders.
Self-management can be improved even further by the integration of device-generated data. With more than 318,000 health apps and over 340 consumer-wearable devices available, this data can help with behavior modification, medication adherence and greatly improved population health.
In late 2017, the FDA issued final guidance with respect to patient access to data generated by medical devices, stating: “Providing patients with accurate and complete information about their diagnosis and treatment, including the data collected from medical devices like blood pressure or heart rhythm monitors, allows patients to be better informed about their health and more active participants in their health care decisions.” This is strong recognition of the value of device-generated data with respect to in-home care for high-acuity patients, chronic and complex case management and early intervention.
However, to take full advantage of this plethora of information, healthcare providers and the patients in their care need to know this information is reliable. Smart contracts on a blockchain platform can automate the permissioned disclosure of device-generated data while also providing verifiability of provenance and reliability of the data.
Through the shared ledger, physicians and other patient care team members can access reliable information that includes the history of the device’s calibration and historical readings. Anomaly readings can trigger permissioned notifications to appropriate team members for immediate action, based on verified data. In-home monitoring, telehealth consultations and post-acute outreach can all benefit from the use of blockchain for device data sharing.
Choosing the right blockchain platform
Nearly every function across the healthcare value chain is primed for a blockchain solution that places the patient at the centre of the process. Not all blockchain platforms, however, are appropriate for usage on an enterprise scale in the healthcare industry.
Pharmaceutical companies, CROs and other institutions must make an informed decision when choosing the blockchain platform to which they migrate their operations – and patient data privacy is the most critical variable.
Some blockchain platforms allow any participant to view all data, including that which is highly confidential. This is a structural flaw, as the system requires the ability to have a single, shared ledger to operate. This single requirement is sufficient to prevent the broad adoption of blockchain technology in the healthcare industry as it is unacceptable for competitive, ethical and regulatory reasons.
Instead, institutions must look to platforms that tackle this inherent privacy challenge. The only blockchain platforms appropriate for the healthcare industry are those that are able to restrict the sharing of data to those who have a “need to know”. This ensures the confidentiality of patient data while also capturing the benefits of a shared distributed ledger infrastructure.
The right type of blockchain platform, integrated in the most appropriate manner, can unite the disparate processes plaguing today’s healthcare industry, increasing data flow, reducing costs and ultimately improving patient experience and outcomes.
Thanks to blockchain, as an industry we can move towards a future where a global network of interoperable entities are connected in an environment where they can exchange data in a secure, confidential manner while putting patients in control of their information and, ultimately, their health.