DiGA (German: Digitale Gesundheitsanwendungen) represents a transformative initiative introduced in Germany in 2019, offering reimbursable health applications that have the potential to enhance digital healthcare. With over 50 DiGAs added to the official directory since their debut, experts in the industry consider them a model for all of Europe.
To build a successful DiGA, it’s important to go beyond healthcare digital applications and care companions as it is necessary to comply with specific BfArM standards. DiGAs take responsibility for detecting, treating, or alleviating disease, effectively becoming a trusted health assistant for the user, which really sets them apart in the market.
DataArt held an online event on 'How to Plan and Design DiGA Apps for Success' to delve into the fundamental pillars of DiGA development, concentrating on the technological challenges and regulatory aspects. The panel of experts was moderated by Olga Romanova, Engagement Manager, DataArt and included:
- Ivan Pantykin, VP Healthcare, DACH, DataArt
- Oliver Hilgers, Head of Digital Health & Innovation, NEXTEC Medical
- Dr. Patrik Scholler, Business Strategy Consultant, Life Sciences Consulting
- Felix Lecuyer, Sovereignty Customer Engineer, Google
- Laura Heidrich, FSR Digital Natives, Google
The DataArt Healthcare and Life Sciences team is pleased to share the highlights of their conversation here on our blog.
DiGAs Uniqueness: Difference from SaMD, Digital Therapeutics and Therapy Companions
Olga Romanova: How is DiGA different from SaMD and Digital Therapeutics or Therapy Companions?
Dr. Patrik Scholler: Software as a Medical Device (SaMD) performs one or more medical functions, necessitating compliance with the Medical Device Regulation (MDR) standards. It's often integrated with hardware, such as medical devices like monitors or hospital equipment, which exchange data. These can be used in hospital or clinical settings and at-home scenarios. The reimbursement model for SaMD differs significantly from other digital healthcare software.
Digital Therapeutics is a unique category that must be evidence-based and function similarly to therapeutic interventions. Thay aim to prevent, manage, or treat medical disorders without using drugs. Examples include psychotherapy or support for conditions like ADHD. These functionalities usually require clinical validation, demonstrating that they provide outcomes comparable to traditional drug treatments. Digital therapeutics often fall under the SaMD classification due to their direct relevance to therapy and decision-making processes.
Digital Therapy Companions may or may not be classified as SaMD. They offer support, guidance, and engagement for individuals on their therapeutic journeys. They can enhance drug therapy experiences by offering mood tracking, diary functionalities, reminders, and educational content.
DiGAs can encompass elements from the categories mentioned earlier. They must be evidence-based. Data security, usability, and MDR compliance are paramount, aligning them with standard SaMD requirements. DiGAs, however, go beyond this. They need to function as medication, possessing standalone clinical, medical, or care pathways' efficacy and offering clear medical benefits.
3 Pillars of DiGA Development
Olga Romanova: What is important for building a successful DiGA app?
Dr. Patrik Scholler: The three pillars are:
- Product Vision/Concept
- Hypothesis for effectiveness and medical benefit
- Product components and therapy journey
- Usability / UX + motivation – user journey
- Early iterations with stakeholders and user – mock-ups
- Financial scenario analysis – business cases
- Technological Fundament
- Key algorithms, architecture /backend/ M-Cloud
- Key requests: data protection / security - interoperability/ export visuals: design - dynamic display of data (self-monitoring)
- Flexibility and scalability: CMS / text / FAQ links web-view
- Regulatory and Clinical Strategy
- Design to classification (whether it’s class I or II)
- Design backwards from endpoints and check if it is realistic
- Find balance to make it effective but also still fund to use
Technological Challenges of DiGAs
Olga Romanova: DiGAs face challenging compliance, security, and development standards, making their journey difficult at times. What are the technological challenges to take into consideration?
Ivan Pantykin: DiGA development may introduce unique technological complexities, if compared to other health apps. User Experience (UX) is important to ensure patient adherence which can be realized via intuitive UI, accessibility, performance, gamification and reward features.
In comparison to SaMD, there are some “not so obvious” features to end users, but they are required as they may affect the timeline, cost, and quality. These can be categorized as follows:
- Interoperability Capabilities: Exporting data in both human and machine-readable formats (HL7 FHIR) and integrating with ePA/Gematik posed challenges during test TI.
- Integration with Insurance Companies: DiGA's reimbursable nature demands careful DiGA code activation planning. Securing a dependable integration point provider with a proxy interface to multiple insurers is pivotal.
- Data Management and Cloud Hosting: Anonymization, analytics, and compliance with the latest requirements in cloud hosting are paramount.
BfArM Requirements for Secure Data Hosting
Olga Romanova: Secure data hosting is an essential part of DiGA. Until April this year BfArM would not approve a DiGA app hosted on American cloud. Now things have changed, haven’t they?
Oliver Hilgers: For DiGA manufacturers, utilizing US-based cloud services has always presented a challenge. However, BfArM has recently revised the requirements in this regard:
- Encrypted personal data can be transferred to service providers with EU branches. and US parent companies if the encryption keys are managed a kept within the EU.
- The service provider must assure us no data transfers or processing will take place in the USA.
- Both parties must confirm no data will be disclosed to the US parent company even if requested by US authorities.
- Legal remedies should be pursued by the service provider in case of a disclosure request.
- Data transfer requires an existing international agreement.
- Prompt notification of disclosure requests and updates on remedial measures must be provided to the DiGA manufacturer.
- Disclosure requests from US authorities must be reported to the BfArM.
Google's Sovereign Cloud Solution for DiGAs
Olga Romanova: Google has introduced the concept of the Sovereign Cloud within DiGA ecosystem. Can you elaborate on what it means for Google services?
Laura Heidrich: It allows you to operate your DiGA on a high-performance hyperscale infrastructure, fully compliant. We equip you with tools for efficient cloud based DiGA operation, ensuring secure usage by millions, all approved by BfArM. To achieve this, we've chosen T-Systems as our reliable partner.
For instance, BfArM's stringent regulations, like key management, find a solution through the Sovereign Cloud.
Felix Lecuyer: Teaming up with T-Systems, a German company, we've created a Sovereign Cloud Solution for our German customers. It fulfills BfArM's DiGA hosting requirements and aligns with its latest guidelines.
This ensures that data remains within Germany. Encryption uses an externally hosted key provided by T-Systems. Consequently, only they possess the key for data access. The setup is managed, eliminating the need for users to handle infrastructure. The Sovereign Cloud guarantees that DiGA providers maintain control over their data while accessing Google Cloud's services in full compliance.
Internationalization of DiGAs
Olga Romanova: News indicates that France and other European countries are adopting DiGA-like reimbursement schemes. Could you discuss the requirements for German DiGAs to enter the French market?
Dr. Patrik Scholler: In addition to language and culture, other adaptations might be necessary, including:
- Modifications to adhere to local regulations, encompassing legal consent forms, and possibly disease codes and target segments.
- Clinical effectiveness could probably be reused.
- Local key opinion leader endorsement and a local sales & marketing setup; at minimum, a go-to-market strategy is essential.
By embracing these considerations, organizations can position themselves for effective expansion and engagement within diverse healthcare ecosystems.
Conclusion
DiGAs represent a step towards digitizing healthcare in Germany, offering reimbursable health applications that provide tangible benefits for patients and the whole healthcare system. Understanding the key pillars of DiGA development and partnering with experts from different domains are vital steps for a successful landing.
Discover effective planning, design, and development strategies to simplify and enhance the integration of DiGA into your business. Access the full panel discussion here: How to Plan, Design and Develop DiGA Apps for Success.
