Digitization of healthcare – Using technology to prioritize the diversity of healthcare products

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As digital products, surveillance aids and the growing use of AI become prevalent in the healthcare system, product developers and regulators must ask tough questions about diversity and bias.

To prevent a health system from running on machines with built-in biases, product developers, regulators and health care providers need to focus on the system’s raison d’être: to improve health and treatment options for the entire patient population.

The prejudices in the healthcare system and the dangers of not listening meaningfully to the experiences of patients were highlighted by Baroness Cumberlege in her 2020 report, First of all don’t hurt. The report raised the issue that parts of the patient population do not really have a say in the development of drugs and medical devices.

The report analyzed how the UK healthcare system responded to patient complaints about three products, all of which caused harm to women or their unborn children. The report was very critical, finding that the concerns and symptoms were dismissed as “women’s issues”. The failure to take action by the Medicines and Health Products Regulatory Agency (MHRA) and healthcare providers in response to complaints has been criticized by Cumberlege and listed as one of many areas of future actions.

The impact of digitization

The digitalization of the medical sector will only exacerbate these problems unless product developers, regulators and healthcare providers take into account the voices of the wider patient population. Artificial intelligence and digital products cannot be as unbiased as the data they use to train their algorithms. If the data is unbalanced in terms of gender, race, ethnicity, age and level of education attained, these biases will indeed be incorporated into new technologies.

For example, researchers worry that algorithms designed to detect skin cancer are less effective at detecting cancers in darker skin tones because the algorithms are mostly trained on people with lighter skin tones. Product developers, regulators and healthcare providers need to be careful to address these biases. This change must permeate drugs and medical devices through all stages of their lifecycle, from engaging a wide range of clinical trial participants to meaningful listening and acting on patient experiences after. commercialization.

Why is there a lack of diversity in product development?

The lack of diversity in product development results from several sources, the first of which is undiversified clinical trials. Characteristics such as race, age and gender and even the level of education attained can affect how a person responds to a drug or medical device. Despite this, clinical trials primarily involve white male participants. Therefore, most patients using drugs and medical devices will not have been represented in the investigative trial. To spot problems that appear in certain demographic characteristics, clinical trial participants need to become more representative of potential patients.

Second, once a product is on the market, post-market surveillance requires health care providers to carefully note, report and act on adverse events. This action may include a modification of the instructions for prescribers or for patients, or a modification of the product itself.

Biases in the original clinical data and in the post-marketing data can affect the safety and efficacy of products for populations that are not properly represented.

Towards equity

It is essential to prevent our health system from relying on products programmed to further marginalize the marginalized. Product developers, MHRA and healthcare providers need to engage and collaborate more with patients and data scientists to ensure algorithmic fairness. This should help facilitate a more equitable healthcare system that not only responds to commercial interests, but also prioritizes patient safety for all.

Digital products themselves could be the enablers to achieve this goal. The clinical trial populations currently come from areas close to university clinical medicine centers. These populations tend to be less ethnically and socially diverse. The fixed hours of a clinical site also mean that women juggling work and childcare responsibilities may find participation impossible. But a mobile health care team paired with digital communication and monitoring tools will reach a geographically larger and more diverse population. During the pandemic, the MHRA has been flexible in allowing clinical trials to be conducted outside of clinical trial sites. If the MHRA accepts that in the future not all clinical trials require a fixed clinical trial site but could be conducted safely through more flexible and mobile means, this will allow a more diverse population to be involved and represented in test data that is used to develop products.

Likewise, the use of digital technology to report and analyze complaints about drugs and medical devices will both facilitate and accelerate the observation of trends that need to be addressed. To this end, the yellow card system, which is the vehicle for reporting complaints and adverse events to the MHRA, is now available as an app. However, an application cannot remove bias in the activities of healthcare providers to determine whether a complaint is “real” or not.

To eliminate this bias, we advocate changing the law so that all adverse events observed by healthcare providers are reported. A physician who determines whether a patient’s product complaint is simply a “woman’s problem” or a reportable adverse event may feel compelled to put aside their biases in the face of a fine or criminal action for failure to do so. declaration. This legal change would lead the MHRA and product manufacturers to hold much richer data sets from which to extrapolate and determine what steps to take to ensure the efficacy and safety of their products for a more diverse population.

Building healthcare technologies – including AI-based products – without absorbing bias presents a challenge for everyone involved in the healthcare system. Digital products should be leveraged to reach more diverse populations for clinical trials and post-market data. Changes in the regulatory system for both clinical trials and post-market reporting will go a long way in supporting a digital revolution that has the potential to reduce the biases highlighted by the Cumberledge report.

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