Digital Health Supporting Biotech and Pharmacy

Digital Health technologies are used widely across the pharmaceutical arena. This involves Apps and wearables convergence around health technology, digital media and mobile devices. This can form a crucial part of allowing clinical trials to be decentralised for monitoring and collection of relevant health data and measuring outcomes in terms of compliance with the clinical trial adherence boundaries.

The areas covered are wide ranging and growing as interconnectivity expands but examples include electrocardiogram sensors in smartwatches which can detect heart rate variabilities, which might be an indicator of a health condition, to the use of microphones, to generate and collect digital biomarkers which are collected by embedded sensors in connected devices.

Predominantly partnerships or collaborations are forged between pharmaceuticals companies and digital health businesses, ranging from wearable technology providers and virtual clinical trials to therapeutic digital developers, to implement these developments.

Artificial intelligence and increasingly Internet of all things are being incorporated into diagnostic tools to improve and assist clinicians (and patients) to help analyse, guide and record clinical exams.

There are significant liability risks for those involved in providing such services at this cutting edge of technology and pharmacy, including of course potential issues between the parties to such developments from intellectual property right and trademark issues.

The ongoing growth in this sector is significant and can include some of the world’s largest pharmaceutical businesses who will be looking to protect their rights and liabilities to supporting businesses.

• Companies that handle data collected from the device if part of the service: Those that are designing, developing, AI, Chat bots or services linked to support and more.
• Companies in a vendor capacity i.e. software houses. The range of examples is endless, from data security concerns i.e. hacking and theft of users details, through to the failure of software in a device causing a mis-diagnosis.

The range of interconnected services and devices will only continue to grow, which in turn will only increase the use and sharing of data and professional responsibilities. This means the emergence of new and evolving risks. A good insurance programme is of course a backstop for the potential financial impact of such risks.

Claims examples

1. A company provides various medical alert devices. A complaint was made alleging that the emergency alert device did not properly alert the appropriate individuals that the device wearer required medical assistance. This could leave the device designers and manufacturers open to claims.
2. A Chinese state-backed hacking group targeted the IT systems of two Indian vaccine makers. By identifying gaps and vulnerabilities in the IT infrastructure and supply chain software they were able to access their systems and potentially sensitive vaccine-related information. The motivation here was “exfiltrating intellectual property and getting competitive advantage”1 .
    

Examples of claims scenarios are not based on actual claims, but are highlighted and shared to evidence where claims may emanate, it should also be noted that insurance coverage provided is very much on a client by client basis so may not provide all the coverage for the examples shown in this ‘discussion document

¹https://www.reuters.com/article/us-health-coronavirus-india-china-idUSKCN2AT20P