Trends in Clinical Medicine
Each medical specialty has unique requirements and approaches. For example, cardiology is focused on advancing technologies for cardiac rhythm monitoring, including the development of wearable electrocardiogram devices and blood pressure monitors. Dermatology has implemented telemedicine and artificial intelligence for image recognition. In neurology, efforts are concentrated on remote monitoring of neurodegenerative disease progression and the development of diagnostic tools for detecting sleep disorders, seizures, and migraines. Furthermore, rehabilitation medicine has benefited from advancements in robot-assisted technology. Finally, in psychiatry and psychology, mental health disorders are increasingly supported by apps offering chatbot interactions and therapeutic interventions.
Even clinical trials now incorporate digital endpoints as efficacy and safety measures, while patient engagement programs are concentrating their efforts on the development of tailored apps and biomarker trackers.
For medical writers, this new field requires understanding specific medical needs and technical product knowledge. Therefore, close interactions between clinical and engineering sciences is essential, and medical writers need to demonstrate knowledge in both areas.
Regulatory Essentials
Official guidelines and directives have been in preparation over the last decade. In the European Union, Digital Health technologies fall under the scope of the 2017 Medical Device Regulation (MDR). Applicable since 2021, it sets the framework for clinical evaluation, alongside the General Data Protection Regulation (GDPR) (Regulation (EU) 2016/679), which addresses data protection and privacy for individuals. In the United States, the Food and Drug Administration (FDA) has provided guidance on Digital Health since 2013, with relevant documents on mobile medical apps, software as a medical device, and cybersecurity.
Medical writers need to be aware of those relevant legal frameworks when producing regulatory documents. This is crucial for Research and Development aimed at obtaining a CE mark or FDA approval for wearables or mobile apps, when collecting biomarkers as endpoints in pharmaceutical clinical trials, or when integrating software into systems that provide health monitoring or recommendations to patients and consumers.
Medical Writer Key Roles
Digital Health in the 21st century is patient-centric and empowers individuals by providing real-time information and actionable insights. In addition to complex regulatory material, medical writers are currently faced with developing new document types, often in collaboration with the end-user to guarantee maximum usability and adherence. They create unique content for mobile health apps, patient education materials, health literacy initiatives, telehealth guides, and health information websites. Medical writers must balance technical accuracy with making information accessible and meaningful to the patient.
Conclusion
Digital Health is a rapidly emerging multidisciplinary field, driven by efforts in clinical development and implementation into patient care. We stand at the brink of a field with the potential to revolutionize healthcare, though the true clinical utility of these innovations has yet to be understood. We recommend that medical writers actively track evolving Digital Health trends, as their influence on the writing profession should not be underestimated.
Within Medical Writing – Emtex Life Science, our medical writers are highly skilled in producing clear, precise documents that effectively communicate these innovations, ensuring that your Digital Health initiatives are accurately represented in regulatory submissions, clinical publications, and industry presentations. With nearly a decade of clinical experience in creating medical content for Digital Health products from inception, we are ready to offer our extensive expertise to ensure your application development efforts are successful.
[Written by Ilona Hubbard, Associate Head Medical Writer ]