Can Digital Tech and Regulators Help Improve Health Equity? | Deloitte US has been saved
By Bill Murray, specialist executive, and Jessica Nadler, Ph.D., managing director, Deloitte Consulting LLP
Health inequities have contributed to a declining average life expectancy in the US, which is now the lowest among the world’s high-income countries.1 While virtual health, remote patient monitoring, and other digital health technologies (DHTs) may have the potential to shrink the health-equity divide, they likely won’t be effective without regulatory frameworks that help ensure clinical trials, treatments, and technologies are accessible and financially viable for people who live in under-represented communities.
The average life expectancy in the United States has fallen to 76.4 years—the lowest average in more than two decades, according to a report from the Centers for Disease Control and Prevention.2 This average is nearly nine years lower than the average life expectancy in Hong Kong (85.2 years).3 Deaths from COVID-19 (now the third leading cause of death in US adults) and drug overdoses—particularly from synthetic opioids such as fentanyl—have contributed to the falling life expectancy.4
Regulators may have a role in reducing health inequities
DHTs, which can include artificial intelligence (AI) and machine-learning (ML), have the potential to expand access to care for underserved populations. A digital device, for example, might make it possible to remotely monitor a patient’s vitals and alert care teams to signs of health deterioration, regardless of how close the patient is to a medical facility.
However, DHTs can also reinforce or exacerbate existing health disparities (in diagnosis and in treatment) if they don’t manage bias and address inconsistent access and outcomes across populations (see US health care can't afford health inequities). Pulse oximetry devices and forehead thermometers, for example, typically don’t perform optimally on patients who have darker skin tones. Furthermore, such tools can be expensive and might be inaccessible for people who lack adequate health coverage or sufficient income.
Federal regulators could be positioned to play an outsized role in advancing DHTs to reduce health inequities. Regulatory guidance could establish guideposts that help to confirm that the needs of diverse populations are considered in both the development and deployment of DHTs for care and in clinical trials. This could help to confirm that digital devices are safe and effective for all people.
Usability is another important consideration if DHTs are to support health equity. In its draft guidance on remote data acquisition in clinical investigations, the US Food and Drug Administration (FDA) recommended usability studies to ensure that DHTs can be used effectively by intended populations.5 Parallel efforts (outside of FDA) that support affordability and access could help ensure that intended populations have opportunities to use these technologies.
FDA introduces call to action
Last spring, FDA Commissioner, Robert Califf, M.D., announced a six-part call-to-action to better leverage health technology, data, and capabilities to improve health care outcomes and equity.6 The FDA's first Artificial Intelligence/Machine Learning (AI/ML)-Based Action Plan describes the agency’s strategies for AI/ML oversight.7 One of the goals is to use AI/ML to promote health equity.8 The agency has also indicated it will support regulatory science efforts needed to develop a methodology for the evaluation and improvement of machine-learning algorithms.9 It is up to regulators to build the capacity and expertise needed to develop guidance that biopharmaceutical and medical device companies can use to equitably develop and implement these technologies.
According to the latest version of the Prescription Drug User Fee Act (PDUFA), FDA has committed to establishing a DHT framework to guide the use of DHT-derived data in regulatory decision-making, publishing guidance on using DHTs in clinical trials, addressing using patients’ own DHTs in trials, and enhancing the agency’s capabilities to review DHT-generated data.10 These commitments are expected to advance the regulatory science to support the safe and effective use of DHTs. (PDUFA, which is renewed every couple of years, allows FDA to collect fees from drug manufacturers to fund the review process. In return, FDA makes commitments to industry to meet performance benchmarks (e.g., faster review times) in order to continue receiving the fees).
DHTs can enable more representative clinical trials
The FDA’s Center for Drug Evaluation and Research is also encouraging researchers and sponsors to make clinical trials more accessible to people who live in underrepresented racially and ethnically diverse populations.11 While the industry is pursuing various strategies to improve diversity in clinical trials, there is consensus on the need to meet patients where they live and where they already interact with trusted health care providers in the community.12 DHTs can be an integral part of this effort.
Consumers who participate in clinical trials typically don’t reflect the diverse fabric of the United States or adequately represent the patients who could benefit the most from the interventions being studied, according to a report from the Deloitte Center for Health Solutions (see Broadening clinical trial participation to improve health equity). Making it possible for people to participate in clinical trials from home or virtually, which could use DHTs, could increase consumers’ willingness to participate by nearly 20 percentage points, according to our survey of 4,545 US adult health care consumers. And making trials available at a convenient site could increase willingness by nearly 10 percentage points according to the report.
In alignment with their Diversity in Clinical Trials Initiative, the FDA announced guidance aimed at increasing racial and ethnic diversity in clinical trials for all medical products. Furthermore, the federal government’s $1.7 trillion omnibus spending package includes legislation that calls on the agency to require sponsors to file diversity action plans alongside phase-3 trials. The law also requires the FDA to finalize its guidance on clinical-trial diversity.
Several initiatives could complement FDA guidance and help the digital health community develop leading practices for integrating health equity into clinical trials and into DHT development and use. The White House’s recently published Blueprint for an AI Bill of Rights contains several elements relevant to health care, including a call for continuous disparity testing to prevent algorithmic discrimination.13 In addition, the Digital Medicine Society has developed a toolkit for incorporating digital inclusion into digital health measurement technology.14
The Deloitte Health Equity Institute’s research on community-based ecosystem approaches to address health inequities has applicability to broadening clinical trial participation in diverse communities. These and other initiatives that support broader access are important in helping ensure DHTs are used to provide safe, effective and equitable care for all people. Regulators will likely play a key role in determining whether health equity becomes embedded in DHT use in support of regulatory decision-making.
Acknowledgements:
Joseph Shawky, Ph.D., manager, and Sandhya Polu, Ph.D., specialist master, Deloitte Consulting LLC
Endnotes:
1 Health equity: Your health outlook depends on where you live, World Economic Forum, January 19, 2023
2 Mortality in the United States, 2021, US Centers for Disease Control and Prevention, December 2022
3 Life Expectancy by Country and in the World , Worldometer, 2023
4 Mortality in the United States, 2021, US Centers for Disease Control and Prevention, December 2022
5 Digital health technologies for remote data acquisition in clinical investigations (draft guidance), December 2021
6 FDA Commissioner Makes Six-Part Call to Action to Improve Health Care, FedHealthIT, April 7, 2022
7 FDA Releases Artificial Intelligence/Machine Learning Action Plan, FDA, January 12, 2021
8 Artificial Intelligence and Machine Learning in Medical Devices, FDA, June 2022
9 Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices, FDA, October 5, 2022
10 Completed PDUFA VI Deliverables, FDA, September 30, 2022
11 FDA takes important steps to increase racial and ethnic diversity in clinical trials, FDA, April 13, 2022
12 Prescription Drug User Fee Amendments, FDA, January 30, 2023
13 Blueprint for an AI Bill of Rights, The White House, October 4, 2022
14 Toolkit for Digital Health Measurement Product Development, The Digital Medicine Society
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