TRUST-BY-DESIGN™ FRAMEWORK PRINCIPLES
Victoria Hailey and Moira Schieke, MD
Version 2.0, June 20th, 2021
(Version 1.1 was published online June 6th, 2019)
Cubismi is pioneering business and technology best practices that we consider essential for establishing trust amongst healthcare professionals and patients using our systems. Our principles will ground the company in standards of medical ethics and high quality healthcare, as well as establish new standards for protecting users’ digital rights. Our principles lay the foundation for our Trust-by-Design framework that fully defines our agile development pathway for Interactive Digital Diagnostics.
The Trust-by-Design framework will assure our developing business and technology systems adhere to both well-established and unchartered guideposts. It will align development of our systems with well-established standards of medical ethics, clinical practice, and human rights. It will also provide a scaffolding for unchartered digital age considerations such as digital rights. (Figure 1) We believe the Trust-by-Design framework is critcal in the current environment of rapid advancement in cloud, big data, machine learning, and deep learning technologies that is far out-pacing the regulations and scientific rigor that protect patients and the public at-large.
Here, we define the core principles that are the cornerstones of our Trust-by-Design framework, as follows:
Cubismi’s commitment to the above principles requires that we create an interactive human-computer system that maintains the doctor as the professional decision-maker.
Intelligence augmentation is defined as a computer system that supplements and supports human thinking, analysis, and planning, while leaving the intentionality of a human actor at the heart of human-computer interaction. The system will protect patients from opaque and autonomous computer-algorithmic decision-making by assuring the tools are controlled by doctors.
Cubismi will deliver technology that will be used as a tool for doctors, with the timeless and critical professional role of doctors being protected. Cubismi’s technology will augment, and in no way replace, doctor intentionality and decision-making.
CONTROL, TRANSPARENCY & ACCESSIBILITY
The rights of patients conferred by our healthcare systems today must be expanded to incorporate digital rights in the new digital era. Digital rights protect a patient’s capacity to control their digital footprint and identity in a manner analogous to their current capacity to control decisions and actions regarding their physical body.
Just as patients must fully consent to surgery, ethics in a digital age demands that patients consent fully to uses of their personal health data. Full consent requires full patient control of their personal health data with complete updates, notifications, and transparency on uses of their data across healthcare systems and third parties. Doctors must be able to access full patient records in order to guide optimal medical decisions across interoperable systems, and patients must be able to access their personal health records easily and on-demand. Patients must have the opportunity to access and scrutinize their personal data and request amendments for improved accuracy in close cooperation with doctors.
New technologies, such as self-sovereign identity, provide an underlying technology to realize personal digital controls for each patient. These new technologies promise a future of radical accessibility and interoperability for patients and physicians to safely, securely, and efficiently access all potential useful data needed for each and every patient care interaction.
Cubismi will provide users with full control, access, and transparency of their personal health data within a system of coordinated patient-doctor data exchange.
FIDUCIARY TRUST & PATIENT-CENTRISM
Trust, which is essential for the delivery of high-quality healthcare, is a cornerstone of medicine. As early as Hippocrates, doctors have believed that practicing medicine demands that they, and the healthcare systems within which they operate, act to protect the interests of patients within a relationship of heightened trust and confidence. If this fiduciary trust is broken — either by doctors or healthcare systems — patients may hide or misrepresent their medical histories and even fail to seek care when needed.
Too often, a power imbalance privileges powerful entities that collect and collate data, often without permissions and physician users to the detriment of their patient data subjects. This power imbalance can lead to abuses of personal data and the development of technology that manipulates and negatively impacts human users. Patient-centric designs empower the patient user and prevent these power imbalances.
Cubismi systems will use patient-centric designs that support the cornerstone of fiduciary trust essential for quality healthcare.
RESPONSIBILITY & NON-MALEFICENCE
Cubismi will design and establish systems that support responsible behavior by its users. While patients are given increased control to affect their own health and well-being, taking personal responsibility for personal data, health, and well-being will be critical for optimizing health outcomes. While doctors are provided a platform on which to optimize and augment the medical care they provide, they will need to fully adhere to the timeless code of professional medical ethics which dictates the boundaries of fiduciary trust, non-maleficence, and responsible behavior.
Without this professional role being maintained, patients will not be able to trust that their data and/or the system is not being disrupted, exploited, or gamed to meet any objective beyond optimizing their care and well-being.
Cubismi’s platform will allow doctors and patients to act responsibly, together, within a complex medical environment to create the right synergy between patient autonomy and professional and fiduciary responsibilities. Cubismi will design and establish systems that support responsible behavior by all its users.
OPEN SCIENCE, ROBUSTNESS & EXPLAINABILITY
Open science that uses open databases is critical for independent validation of the quality of population datasets, as well as for independent validation and auditing of the accuracy and robustness of machine learning and deep learning algorithms. Open databases allow independent validation of dataset quality used in patient care. Poor data quality used in big data systems can create poor outcomes that reverberate in unpredictable ways, which too often results in poor quality patient care, and even harm. Open databases also provide for the potential for larger population-wide databases such that computer algorithms can be designed for optimal efficacy and robustness across healthcare systems, and to avoid errors due to bias and overfitting. Open science validation using open databases assures vendors do not misrepresent, manipulate, or otherwise misuse computer algorithms to push profits at the expense of patient safety and clinical care outcomes.
Explainability also ensures system robustness, as opaque computations and data inputs cannot be compared and audited across healthcare systems. Explainability of computer predictions and inputs also ensure that the system can be validated and audited to assure it is behaving as intended in clinical practice, and to avoid potential harms caused by bias, unintended system variations, adversarial attacks, and other sources of error.
Cubismi will utilize open science and open databases to allow third party quality assurance of its systems, and to assure optimal data science system quality and robustness. Explainability of the Cubismi system will also be essential for ensuring system quality, robustness, and safety.
SAFETY & ACOUNTABILITY
Traceability, continuous monitoring, and dynamic processes that engineer safety into our products will enable Cubismi to keep its systems safe by managing all potential risks and harms, as well as by assuring accountability when systems fail. Overall system safety will be assured through close evaluation of outcomes that are the result of designing human factors in conjunction with computer algorithms in patient care decision-making, through theimplementation of continuous risk-mitigation strategies.
Cubismi will assure that physicians play a critical safety oversight role in the human-computer interactions within ourdigital medicine systems.
PRIVACY & SECURITY
Privacy must be a protected, basic human right, as supported by the UN Declaration of Human Rights. Patients depend on their healthcare providers to ensure that their most intimate, personal information is protected worry-free, yet full protection of patient data privacy has proved challenging in a new digital era. Patients are increasingly demanding privacy rights over their digital health data to prevent third parties from exploiting their digital footprint. Protection of personal health data also requires enhanced cybersecurity where patients know that their data is not being made available to third parties via security breaches.
Cubismi’s commitment to privacy is based on a privacy-by-design strategy that will not only protect patients’ privacy rights, but will work to assure the highest level of cybersecurity for the protection of patient data.
DIGNITY, AUTONOMY & RESPECT
When patients seek medical treatment, they are typically at their most vulnerable and rely on healthcare systems and healthcare professionals to protect their dignity and autonomy. New digital technologies demand new systems design to assure continued protection of patient dignity and autonomy. For example, systems must avoid technological manipulation of users similar to tactics used by social media companies to non-transparently collate personal data and foster addiction in order to increase product usage. Similarly, computer systems that act to impose a value system on users by nudging, misinformation, or other tactics undermine individual autonomy in establishing personal value systems. Patient autonomy is especially critical in a healthcare setting such that individuals remain in full control of decisions impacting their person, health, and well-being.
Cubismi will remain agnostic to user values systems, and will design and establish systems that fully respect the dignity and autonomy of each user.