Inserting the Patient Voice: Ethical Challenges in the Use of Healthcare Data

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Patient advocate and regular PharmaBoardroom contributor Monica Weldon examines how healthcare’s data revolution has thus far largely ignored the patient voice and argues for a more inclusive approach to drive better, fairer outcomes.

  

It is natural to want to be healthy, have healthy children, have the best quality of life, and hope for future treatments and technological advances to benefit future generations. As healthcare technology advances, so do the challenges of maintaining acceptable ethical boundaries within the realm of healthcare, both locally and globally.

 

Technological advancements have accelerated quality of life for many, including through faster diagnosis; the development of new, innovative, and less invasive procedures; and accelerated drug development timelines. Healthcare experts have acknowledged the positive impact of the rapid growth of technology on medical research, patient welfare, and healthcare systems within the framework of “Doing No Harm.”

 

The best way to create an oversight that will benefit the patient community is through having patients act as a type of “watchdog” at every level, from basic research to clinical trial design

 

However, over the last two decades, this technological revolution in healthcare has also raised ethical concerns across both the private and public sectors, nationally and internationally. Many are concerned about opportunists and bad actors in the space taking advantage of patient health data and using it for monetary gain. Additionally, the absence of the patient voice in Artificial Intelligence (AI) development has resulted in faultily programmed models. The debate is ongoing and there is a clear need to create a socially acceptable ethical framework for advancing healthcare technologies. The best way to create an oversight that will benefit the patient community is through having patients act as a type of “watchdog” at every level, from basic research to clinical trial design.

 

The computer age in healthcare exploded with the introduction of the worldwide web and helped create the world of Big Data and a proliferation of digital information. Advances in data storage and processing technology have dramatically changed the speed and volume of data analysis capabilities and given rise to predictive analytics.

 

There is no doubt that the age of technology has advanced modern medicine, surpassing the introduction of disinfectants in the early 1800s and the discovery of pharmacological antibiotics in the early 1900s. The advancement of data processing and data in healthcare has become a goldmine for medical research, biotech, and pharmaceuticals with how human data is used in research studies becoming a hot topic. However, concerns have grown regarding data gathering and analysis, the bias in wealth and power inequalities, and the increasingly impersonal connection between healthcare workers such as physicians.

 

There is no argument that the collective perception of monetizing health data is increasing in value, although this perception varies depending on the audience, whether patient, academic, biotech company, or Big Pharma. The most important question is the actual value cost of this data’s use and whom it will ultimately benefit. Often, the patient and patient communities are not included in the equation and are not reaping the benefits of using their health data for research.

 

Over time, the patient voice has been an invaluable driver of new treatments and a collective patient voice has already helped change the landscape for patient communities in the Big Data market. Many patient communities create and steward their databases, giving them the possibility of benefiting monetarily from the data’s use, with returns going back into the community they serve. However, many healthcare providers believe that financial incentives are negatively impacting patient quality of care and that the very foundation of the medical industry is at risk due to the monetization of healthcare.

 

There is still a continued resistance from academia and biotech towards including the patient voice if it impacts their own monetary gain, publication acknowledgements, and shared intellectual property

 

Why is there so much disparity between professionals’ perceptions of direct patient involvement in this process, given that it can potentially create more sustainable financial models that benefit the community? There is still a continued resistance from academia and biotech towards including the patient voice if it impacts their own monetary gain, publication acknowledgements, and shared intellectual property.

 

Over ten years ago, the Cystic Fibrosis Foundation created a business model which proved unpopular with other drug development stakeholders, investing in drug R&D programs and eventually reaping the monetary rewards of an approved drug for the condition. The community at first struggled to accept that though the nonprofit was not a “for-profit” business, the model would benefit the community as a whole in the long term. To this day, the organization continues to make a royalty from the product in which they invested, and the funds go back into the community, meaning that the risk they took paid off. Although questions were asked about compliance and conflict of interest, inserting the patient voice was critical to ensuring that a treatment for the disease was created.

 

Patients have the experience to help see problems at the grassroots level. Taking ownership in what rightfully belongs to them and affects their quality of life is essential. Patients and caregivers alike should be taking action to create new pathways in the form of advisory committees, board memberships, and company liaisons that speak to their experience on the ground. Business degrees and certifications are not a requirement; it is about being assertive and talking not just about the problem but ways to fix it. Advocates also should not fall into the trap of not expecting to be compensated for their expert opinions and experiences. The patient voice is invaluable, and academia and industry alike should be appreciating the boost it gives to their work, understanding the role and how the patient voice is moving both their missions and research forward.

 

Patient community participation has helped shape bioethics and procedures that include the patient voice across developing standards of care, better-designed research protocols, and better clinical trials. Organizations stewarding their databases using a business model of this type could potentially benefit the patient community. Data is a different type of asset that is gold in the drug development landscape. Rarely do you see a patient organization monetarily helping and seeing a monetary return to those who contributed their data to the research. Most data companies make a great deal of profit off the patients they are benefiting. Many do not turn around and give a fair market value back. Creating these types of arrangements no longer leaves out the people suffering from disease and disassembles the monopoly of data control that academic institutions, third-party data firms, and pharmaceutical companies currently often hold.

 

AI and machine learning are two of the newest and most important forms of technological advances which are now transforming the way in which healthcare is being delivered. Health organizations have accumulated vast data sets in health records and images, population data claims data and clinical trial data.

 

What if we treated computer coding like clinical trial design and began to insert the patient voice in it?

 

The use of AI in health data mining is, however, still in its infancy and, moreover, the patient voice and inclusion of patient experience in its development is almost null. Typically, computer scientists develop algorithms codes that collect specific data points. The programs and software are only as good as the programmer. Many errors in coding and keeping up with the changes in software updates can alter the data outcomes, change results, and risk the investments and time that go into initial data collection and studies looking for valuable treatments for people dealing with diseases. These problems will have long-term effects if not addressed and a solid strategy for the best outcomes for both the healthcare industry and their patients. Would the patient voice help resolve some of the potential gaps that coders miss because of lack of experience in the endpoints of the disease they are coding? What if we treated computer coding like clinical trial design and began to insert the patient voice in it?

 

The advancement of modern technology in healthcare is undoubtedly a question about the benefits of improving people’s quality of life, finding innovative therapies, and new treatments. However, as a global society, we must work together to ensure the safety and accountability of those using technology as a tool for good and protect it from being abused. Creating an inclusive and non-biased perception will require healthcare leaders with cognizance, curiosity, cultural intelligence, collaboration, courage, and commitment. These qualities, along with educated experts in both the science and the regulatory policy space, will create a path to an integrated culture that takes both people and performance into consideration.


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