The COVID-19 pandemic and changes in legal frameworks have sparked and accelerated the major trend of digitalization in the health sector. This trend is expected to result in merging digital products, including medicinal products and medical devices, into a digital ecosystem supported by shorter development cycles and technological progress. Digitalization is expected to improve patient sovereignty and enable more patient-centred medicine, with artificial intelligence improving and accelerating diagnoses and contributing to a better understanding of disease patterns and underlying mechanisms. Indeed, regulatory agencies across the globe are expanding and broadening their horizons to support digital transformation. For example, Germany’s BfArM has taken a significant step towards a more digital healthcare system, reinforced by the experience gained from the COVID-19 pandemic.
The BfArM is contributing to this transformation by expanding the Research Data Center, addressing interoperability, conducting research projects using artificial intelligence, cooperating internationally, utilizing “Real World Data,” and evaluating digital health and care applications to improve patient safety and readiness for digitalization in Germany and Europe .
Digital Health Applications
Digital therapeutics have significantly expanded since 2018, and rapid growth is expected over the next decade. The COVID-19 pandemic has revolutionized digital health adoption and innovation, mainly driven by the unprecedented demand since early 2020, particularly in areas that provide alternatives to in-person care, such as virtual care and digital therapeutics. Mental and behavioural health, such as anxiety, depression, and substance abuse, is an area where digital health tools have proven to be particularly suitable.
Digital health applications, or DiGAs, are software-based tools that leverage technology to support health and wellness goals. These applications can be accessed through mobile devices, desktop computers, or wearable devices such as smartwatches. They offer a range of features such as tracking health metrics, providing health information, facilitating communication with healthcare providers, and delivering personalized health coaching.
There are several types of digital health applications, including:
- Wellness and fitness apps
- Remote monitoring apps
- Telemedicine apps
- Mental health apps
- Patient engagement apps
The Future of Digital Health Applications
Digital health applications have the potential to improve healthcare outcomes by enabling patients to take a more active role in managing their health and providing healthcare providers with real-time data on patient health metrics. However, it is important to ensure that these apps are secure and comply with data privacy regulations to protect patient information .
The future of digital health applications is very promising. As technology continues to advance, we can expect to see even more innovative and sophisticated apps that offer a wide range of benefits for patients and healthcare providers.
Developments in various technological areas such as Internet of Things (IoT), Big Data analytics, artificial intelligence (AI), augmented reality (AR), blockchain, and mobile technologies will have a significant impact on how services, including healthcare, are delivered worldwide.. Healthcare is expected to have one of the largest IoT and big data analytics applications, with estimates suggesting that healthcare applications will account for 15% of global IoT applications by 2020  .
AI and Digital Healthcare
The use of AI in healthcare has led to significant advancements, with smart devices and high-speed data transmission techniques allowing for devices like wearable sensors and robot nurses to monitor and diagnose diseases. However, there are challenges in data transmission, cost-effectiveness, and communication.
AI can simulate human decision-making and reasoning processes, utilizing expert systems, machine learning, natural language processing, image processing, and other technologies to learn from massive data and make accurate predictions. This provides medical staff with auxiliary diagnosis and treatment to reduce workload and improve efficiency. AI-based intelligent systems are widely used in the medical field, particularly in imaging inspection, where they can analyze and classify lesions to improve the accuracy and efficiency of diagnosis. The Da Vinci surgical robot system is an example of an AI-based medical robot that has advanced modern clinical medicine by completing operations that cannot be done manually .
IOT- Internet Of Things
The IoT enables the interconnection of everyday objects through information-sensing devices, with enormous potential in the medical field, including enabling intelligent management, data collection and sharing, reducing medication errors, improving work efficiency, reducing medical costs, and enabling remote patient monitoring. Real-time monitoring through the IoT can help manage patients remotely and ensure their health by diagnosing them promptly when their physical data is abnormal.
Big data refers to large and complex datasets that cannot be easily managed and processed using traditional software tools. Healthcare is a promising area for big data applications as it allows for the quick extraction of valuable information from various types of data, including electronic medical records and medical equipment. Big data technology enables the proposal of personalized treatment plans for patients, the prevention of diseases, and the improvement of hospital management and scientific research capabilities. It also assists doctors in diagnosis and treatment, reduces the rate of misdiagnosis, and provides hospital managers with scientific information for management decisions.
Opportunities for Pharmaceutical Regulators Regarding Digital Health Applications
Digital healthcare applications offer several benefits to pharmaceutical regulators, such as real-time monitoring of drug safety, improving drug development through big data analytics and AI, enhancing patient engagement, ensuring better regulatory compliance, and improving collaboration and information sharing. These benefits are crucial for improving patient safety, drug development, and regulatory compliance, especially as the healthcare industry evolves. Thus, regulators must embrace digital tools to provide the best possible care to patients.
However, the rapid development and growth of digital health applications have posed significant challenges to pharmaceutical regulators. They need to keep up with the evolving landscape of digital health technology to ensure that these applications meet safety and efficacy standards and do not harm patients.
To address this, regulators need to create new regulatory frameworks designed specifically for digital health applications. These frameworks should ensure that digital health applications are safe, effective, and valuable to patients.
Moreover, pharmaceutical regulators must stay informed about the latest digital health technologies and trends to ensure that their regulatory frameworks can adapt to new developments. They should also collaborate with industry stakeholders to promote innovation while regulating digital health applications appropriately and avoiding unnecessary regulatory burdens.
In summary, the future of digital health applications presents both opportunities and challenges for pharmaceutical regulators. By implementing the right regulatory frameworks, regulators can help ensure that these applications are safe, effective, and provide value to patients.
References and Further Reading
 BfArM Germany. Digital Future. Federal Institute of Drugs and Medical Devices Germany. 2023
 BfArM Germany. DiGA: Digital Health Applications. Federal Institute of Drugs and Medical Devices. 2023
 Sharma R, Kshetri N. Digital healthcare: Historical development, applications, and future research directions. International journal of information management. 2020 Aug 1;53:102105.
 Douissard J, Hagen ME, Morel P. The da Vinci surgical system. Bariatric robotic surgery: a comprehensive guide. 2019:13-27.