In the fast-paced world of digital health, turning an innovative idea into a trusted product demands not only technical expertise but also a deep commitment to ethical regulation and consumer-oriented policies. 

Consider products that allow a caregiver to passively surveil an older adult, remotely monitoring their location and activities. While these technologies were designed to enhance safety, they often fail to account for the values and privacy concerns of older adults themselves, limiting their adoption and efficacy. 

A recent article from Senior Fellows Emily Largent, Jason Karlawish, and Anna Wexler provides product developers across the digital health life cycle with recommendations for emphasizing ethical and regulatory concerns and accounting for environmental impact. These recommendations can help address disparities and safeguard user data while fostering innovation in mobile health apps, electronic medical records, telemedicine, wearable devices, and more.

Below, we summarize the article’s four key points:

  1. Start thoughtfully when generating ideas: Start with identifying unmet user needs, involving diverse stakeholders, and addressing potential ethical challenges early. For example, including people with disabilities during development is crucial for accessibility. Deaf users, for instance, might suggest visual or vibrotactile alarm systems in addition to common auditory alarms.
  2. Design and prototype inclusively: Ensure inclusive design by uprooting developer-encoded biases and considering risks and benefits. A key example is wearable heart rate monitors that use green light, which has been shown to work less accurately in individuals with darker skin. Rather than offering devices that are more useful for lighter-skinned people, developers should design them to work equitably for all skin tones.
  3. Be sure to validate and certify: Validate technical, clinical, and usability aspects of devices among diverse populations, adhering to ethical research standards. For instance, pulse oximeters—used to measure oxygen in red blood cells—were validated using homogenous subjects with mostly lighter skin tones, leading to inaccuracies for patients with darker skin tones. This became especially apparent during the COVID-19 pandemic. Validation across diverse user bases can prevent such disparities.
  4. Consider commercialization factors: Focus on regulatory compliance, market approval, equitable access, and sustainability. Users should receive education about products so they can make informed decisions about using them. Firms should treat workers fairly in the supply chain. Ensuring equitable access to digital products is a notable challenge. For instance, lower-income and rural communities often lack broadband access, limiting use in these areas of products that require internet connectivity.

As the digital health landscape expands, developers must be held accountable throughout the product-development life cycle, ensuring that digital tools reach their potential to improve health outcomes equitably.

To learn more about common issues within digital health and how stakeholders can address ethical and regulatory concerns, see the full article here.


The study, “From an Idea to the Marketplace: Identifying and Addressing Ethical and Regulatory Considerations Across the Digital Health Product-Development Lifecycle ,” was published on July 25, 2024 in BMC Digital Health. Authors include Emily Largent, Jason Karlawish, and Anna Wexler.


Author

Miles Meline

Miles Meline, MBE

Senior Policy Coordinator


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