The current main challenges are lack of rules related to the secondary use of health data and harmonization among the rules when those already exist. In the European Union, there is a common goal to enable secondary use of health data within the member states but also cross-border sharing of health data. Even in the EU the main responsibility of setting the suitable policies and implementing the right kind of data governance and data systems is with the individual countries.
For the companies operating in the health data sector, such as RemedyBytes, it is crucial that these policies and processes are put in place as quickly as possible to allow innovation and implementation of better healthcare solutions in the current landscape where there is a rapidly growing cost pressure.
Why do we need secondary use of health data?
In short, the idea is that the health data could be reused, anonymised and aggregated, to improve people’s health and experiences, for example by enhancing personalized healthcare, to create more efficient healthcare systems, and to foster innovation.
Secondary use of health data enables a wide range of use cases and benefits across the entire healthcare system, the benefits including:
- Optimizing health service delivery
- Reducing health inequalities through better allocation of resources
- Helping to enhance personalized healthcare
- Increase innovation
Secondary use of health data can increase the value of currently collected data from clinical settings and information collected from other data sources. The other sources of health data can be for example from registries, sickness and insurance claims records and from devices and wearable technologies. This “other data” is often referred to as real-world data (RWD).
Optimizing health systems
Secondary use of health data for analytics and management can reduce healthcare costs. The expectation is that better data governance allows the secondary use of health data from within the organization and other similar healthcare organizations globally will increase planning capabilities and more-efficient allocation of resources.
Delivering data-driven digital health technologies sustainably at scale would allow more equal prioritization in healthcare organizations. These tools might have the potential to provide everyone, everywhere, with equitable access to expert-level care, narrowing the global health and wellbeing gap.
In addition to being able to prioritize and equalize the healthcare system, one of the earliest motivations to improve secondary use of health data has been to modernize reimbursement and pricing models. The ability to access and analyze metadata is crucial for the value-based healthcare thinking and for the new types of pricing models, such as pay-for-performance.
In general, it is possible to see challenges in most of the opportunities and benefits that were described above if things are managed incorrectly.
The Joint Action Towards the European Health Data Space (TEHDAS), which will be discussed in more detail below, issued a report that identified in total 20 barriers for secondary use of health data and they narrowed it down to these 11 barriers in Europe which mainly apply globally:
- There are differences in governance and health data systems between different countries.
- A lack of a common interpretation of what constitutes ‘sufficient anonymisation’ to transform personal data to non-personal data.
- A lack of a common interpretation of what constitutes ‘pseudonymisation’.
- A lack of a common interpretation of what is and is not ‘secondary use’ of data.
- National laws/rules on health and research data in addition to the GDPR and similar data privacy legislation.
- European countries can set different derogations under the GDPR.
- European countries have different preferences as to the choice of legal basis for processing personal data under the GDPR.
- Health data is considered sensitive data e.g., special category data under the GDPR, and is treated differently from other types of data when it comes to health data ethics, management, and use.
- A lack of standardized data sharing agreements for products developed by private sector providers using public health data to facilitate safe data sharing and protect public investment.
- The use of different interoperability standards makes comparisons and sharing data and research results challenging.
- Poor data management procedures reduce the ability to reuse data.
European Health Data Space
The general purpose of the health data space regulation and initiative is to ensure that people have increased control over their electronic health data. The regulation also aims to ensure a legal framework consisting of governance mechanisms and a secure processing environment, allowing researchers, innovators, policy-makers and regulators to access relevant electronic health data. The regulation for health data space should contribute to a single market for digital health products and services, by harmonizing rules, and so boost healthcare system efficiencies.
As of today, in some EU countries, for example Finland, there already exists a separate law on the secondary use of health and social data, which may or may not have to be amended once the regulation becomes effective.
What is the current situation in the EU?
EU countries are taking measures to develop a framework for the use of secondary health data to achieve the goal of having clear rules, common standards, and practices on health data sharing and to be in the situation where one in three EU Member States offer cross border access to EHRs in the next couple of years.
So where are we now? This can be looked at from different perspectives and below are a couple of different summaries.
Overview of the situation in the 27 EU countries as assessed by eHealth Network:
- 26 provide their citizens with access to EHR data by law
- 18 indicate that data sharing of EHRs across national borders is permitted by law
- 27 have a digital health authority, with different tasks related to interoperability, security, data protection, tele-health and m-health
- 24 report that competent authorities aim to facilitate semantic and technical interoperability
Open Data Institute (ODI) that was mentioned in the beginning of the text has generated an overall score for policy on secondary use of health data based on two measures:
- What is the quality of policy activity for this component?
- What progress is being made on implementation?
How well is your country doing on policy for secondary use of health data? ODI Tool
- United Kingdom 82%
- Finland 81%
- Denmark 75%
- Sweden 73%
- Austria 66%
- Spain 65%
- European Commission 64%
- Slovakia 64%
- Norway 63%
- Belgium 63%
- Luxembourg 62%
- Italy 61%
- Poland 61%
- France 59%
- Czechia 59%
- Portugal 58%
- Israel 57%
- Ireland 55%
- Estonia 55%
- Netherlands 51%
- Germany 49%
- Slovenia 47%
- Croatia 45%
- Lithuania 45%
- Switzerland 43%
- Latvia 43%
- Romania 38%
- Hungary 30%
- Bulgaria 24%
- Greece 20%
ODI and Roche put the European countries into the following groups
Leaders: countries where the quality of policy is stronger and the stage of implementation is more advanced.
Limited energy: countries where the quality of policy is stronger but the stage of implementation is less advanced.
Limited vision: countries where the quality of policy is weaker but the stage of implementation is more advanced.
Less prepared: countries where the quality of policy is weaker and the stage of implementation is less advanced.