Digital toolbox guides health innovators through regulations

The potential for innovation in healthcare is huge, and many want to develop services and products based on health data. However, health data often contain sensitive personal information, and the pitfalls are many.

“The background to the HDS Legal Toolbox is that there are a lot of laws and regulations that companies in the healthcare sector need to take into account. The regulatory frameworks are also complex,” says Paul Johannesson.

“That is why it is important for companies in a development process not to wait too long before addressing regulatory issues. If you address this early on, it is much easier than trying to add it at the end of the process,” he continues.

Paul Johannesson is Professor at the Department of Computer and Systems Sciences (DSV) and one of the creators of the HDS Legal Toolbox. It is a digital service that helps small and medium-sized enterprises navigate the regulatory jungle.

“Our toolbox cannot replace legal expertise, but it can provide an initial understanding of what is required. This allows entrepreneurs to become better at asking questions, understanding what lawyers need – and understanding the answers they receive from lawyers,” says Johannesson.

We have created a crash course in health data and law

The HDS Legal Toolbox has been launched and is already available for use, but Paul Johannesson continues to develop it together with Jöran Lindeberg, a PhD student at DSV. The service includes, among other things, overviews of different regulatory frameworks, maps of ecosystems within the healthcare sector, case descriptions of different types of companies, real legal cases, and other resources.

“Different people learn in different ways, which is why we have tried to approach the subject from multiple angles. For example, we have created a crash course in health data and law to provide the big picture. We really want to encourage companies to start thinking about this early on. Some tend to design too much before addressing legal issues, which means they will have to backtrack significantly later on,” says Jöran Lindeberg.

He notes that there is uncertainty within the legal system.

“Sometimes different legal experts disagree on what is required, and it can be difficult for companies to know what applies. But some issues can be clarified by reading decisions from authorities, legal cases, and court rulings. That is why we include a number of such examples, with a particular focus on data protection decisions from the Swedish Authority for Privacy Protection.”

Chat with an AI agent

Johannesson’s and Lindeberg’s toolbox also includes several AI agents for health data that users can chat with.

“They are essentially standard chatbots, but we have tweaked them and given them specific instructions. We have defined what type of information users are looking for and how the AI agents should interact,” says Jöran Lindeberg.

A user who enters the HDS Legal Toolbox can input information about their own company and then receive a tailored legal guide. For example, if a startup has developed a diabetes app where users enter their blood sugar data, which is then sent for analysis in another country – there are specific regulations that apply. And the AI agents have an overall understanding of these.

“If you don’t know where to start looking, the toolbox is a good entry point. You receive recommendations tailored to your project, tips on relevant legal cases, and answers to questions such as ‘How do we assess the risk class of our product?’” says Lindeberg.

Den här artikeln finns också i en svensk version

Text: Åse Karlén