Transformative Digital Health Tech: Focus on Outcomes, Privacy, Workflow, Data Ownership

by Barry P Chaiken, MD
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The emergence of wearable digital health technologies (DHTs) can revolutionize healthcare by providing personalized, data-driven insights into patients’ health and well-being. As these technologies progress from experimental applications to routine use in clinical care, healthcare stakeholders must address several critical challenges to realize their full potential, as outlined in a recent New England Journal of Medicine article.

Data ownership and patient privacy remain a primary concern regarding the use of DHTs. Patients require free access to their data and maintain control over its use. They are the sole owners of their health data and must provide informed consent to share their data for medical research or commercial product development. As suggested in the NEJM article, a “digital health counselor,” akin to a genetics counselor, may be needed to assist patients and clinicians with integrating technology, including facilitating access, teaching digital literacy skills, and interpreting clinically relevant data. Additionally, healthcare organizations must implement robust security measures to protect patient information from unauthorized access and potential breaches, ensuring the utmost respect for patient privacy.

Ensure Interoperability

Effective use of DHTs demands full interoperability. The need for widely adopted standards, such as those developed by the Institute of Electrical and Electronics Engineers (IEEE), can lead to removing data-sharing barriers and advancing the potential for DHTs to improve patient care. We must reject proprietary data formats that hinder interoperability. The Food and Drug Administration (FDA) provides guidelines for determining which “mobile medical applications” qualify as medical devices and require regulatory oversight, ensuring that these devices are safe, effective, and interoperable. However, it is not a task for a single entity. Collaborative efforts among healthcare providers, technology companies, and regulatory bodies are necessary to establish and enforce these standards, making everyone feel included in this transformative process. As the Office of the National Coordinator for Healthcare Information Technology (ONC) is responsible for fostering interoperability, it is best equipped to bring together relevant stakeholders to establish standards.

Further research is needed to fully understand the potential impact of DHTs on patient care and outcomes. Studies should focus on identifying the specific data points and devices that offer the most significant benefits in various clinical contexts. By leveraging the power of analytics and AI, researchers can uncover best practices for integrating DHTs into clinical workflows, optimizing their value while minimizing potential disruptions.

Prioritize Clinical Workflow

As DHTs generate vast amounts of data, physicians need to be able to incorporate this information into their clinical workflow effectively. Organizations must ensure that the data presented to physicians is valuable and actionable rather than requiring them to discern its relevance in patient care. Artificial intelligence (AI) can significantly address this issue by identifying the most valuable data points and devices and determining the most effective ways to utilize them within acceptable clinical workflows. AI algorithms can analyze patterns and correlations within the data, providing physicians with actionable insights to support their decision-making process. However, ongoing investigation is required to identify the most effective way DHT data is presented to healthcare professionals and patients.

Benefits and Risks

The NEJM article cites a study showing that patients with diabetes who use an open-source, community-built smartphone app that captures glucose and insulin pump data from commercial devices improve their insulin control by adjusting their insulin levels more frequently. This study demonstrates the potential for DHTs to empower patients and improve health outcomes.

While DHTs hold great promise for personalizing patient care, it is essential to recognize the potential risks and challenges associated with their implementation. False alarms from wearable DHTs, such as smartwatches that monitor heart rhythm, may lead to unnecessary medical evaluations and increased healthcare utilization. AI methods have shown promise in reducing false alarms, especially using large, high-quality data sets for training. Healthcare organizations and DHT companies must prioritize advancing medical research and improving care quality, safety, and access while mitigating potential drawbacks.

Reimbursement and return on investment for healthcare systems are significant factors in the widespread adoption of DHTs. Evidence of clinical effectiveness and cost savings is needed to justify the investment in these technologies. There is now a set of Current Procedural Terminology (CPT) codes for remote patient monitoring with wearables, which cover FDA-cleared or FDA-approved devices, their setup and patient education, remote monitoring, data reading, and patient consultations, with some restrictions. However, devices and procedures that do not meet existing CPT definitions still present serious challenges in securing reimbursement.

Stakeholder Collaboration

As the adoption of DHTs continues to grow, ongoing collaboration among healthcare providers, technology developers, policymakers, and patient advocates is essential. By working together to address the complex challenges surrounding DHT integration, including informed consent, data security, patient control, interoperability, and clinical workflow integration, we can create a future in which these technologies seamlessly complement traditional medical practices. Earlier interventions, more proactive disease management, and a greater emphasis on preventive measures made possible by DHTs can reduce the burden of chronic conditions, prevent costly hospitalizations, and optimize resource allocation. By harnessing the power of DHTs, we can empower patients and providers alike to make informed, data-driven decisions that lead to better health outcomes for all while advancing the vision of precision medicine.

Source: Key Issues as Wearable Digital Health Technologies Enter Clinical Care, NEJM, March 20, 2024

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