In the fast-paced world of digital health, turning innovative ideas into reliable products requires not only technical expertise but also a deep commitment to ethical regulations and consumer-oriented policies.
Consider products that allow caregivers to passively monitor seniors and monitor their location and activity remotely. Although these technologies are designed to improve safety, they often do not take into account older adults’ own values or privacy concerns, limiting their adoption and effectiveness.
A recent article by Senior Fellows Emily Largent, Jason Karlawish, and Anna Wexler highlights ethical and regulatory concerns and provides recommendations for product developers across the digital health lifecycle to consider environmental impact. provide information. These recommendations will help address disparities and protect user data while fostering innovations such as mobile health apps, electronic health records, telemedicine, and wearable devices.
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Here are four key takeaways from this article:
Start carefully when generating ideas. Start by identifying unmet user needs, engage diverse stakeholders, and address potential ethical challenges early. For example, including people with disabilities during development is critical to accessibility. For example, a hearing-impaired user might suggest a visual or vibrotactile alarm system in addition to a typical audible alarm. Inclusive design and prototyping: Ensure inclusive designs by eradicating developer-coded bias and considering risks and benefits. A prime example is wearable heart rate monitors that use green light. This has been shown to not work accurately on people with darker skin. Developers should design devices to work fairly for all skin tones, rather than offering devices that are more convenient for people with lighter skin. Ensure validation and certification: Adhere to ethical research standards and validate technical, clinical, and usability aspects of the device among a diverse population. For example, pulse oximeters, used to measure oxygen in red blood cells, were primarily validated using light-skinned homogeneous subjects, resulting in inaccuracies in darker-skinned patients. . This has become especially evident during the COVID-19 pandemic. Validation across a diverse user base can prevent such discrepancies. Consider commercialization factors: Focus on regulatory compliance, market approval, equitable access, and sustainability. Users need to be educated about products so that they can make informed decisions about their use. Companies must treat workers fairly within their supply chains. Ensuring equitable access to digital products is a significant challenge. For example, low-income and rural areas often lack broadband access, limiting the use of products in these areas that require an Internet connection.
As the digital health landscape expands, developers must take responsibility throughout the product development lifecycle to ensure that digital tools fulfill their potential to equitably improve health outcomes.
To learn more about common issues within digital health and how stakeholders can address ethical and regulatory concerns, read the full article here.
This study, “From idea to market: Identifying and addressing ethical and regulatory considerations throughout the digital health product development lifecycle,” was published in BMC Digital Health on July 25, 2024. Authors include Emily Largent, Jason Karlawish, and Anna Wechsler.
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