Twelve ministries and agencies spent a combined 3.9 trillion won on bio data projects last year. The sum approaches 4 trillion won, yet an analysis of those projects by the National Bio Innovation Committee paints a dismal picture. More than half the money went to data "analysis" (25.1%) and individual "utilization" such as research and drug development (25.0%). By contrast, "linkage, sharing and opening" — connecting and sharing data across institutions — drew 163.1 billion won (4.2%), and "processing and refining" received a mere 7.6 billion won (0.2%).
The bigger problem is that the data formats produced by these projects are all different. When the committee examined 229 datasets, it found 93 built on self-defined models and 77 stored as raw source material, accounting for the bulk of the total. Only 15 used global standard models, and not a single one used a domestic public standard model. Exchange methods were mostly Excel or CSV files, with only five cases applying the international FHIR standard.
Despite the enormous outlay, the neglect of infrastructure for connecting data has left behind nothing but hundreds of "data islands," each built separately by individual ministries and project groups. It is textbook budget waste, produced by the departmental self-interest that comes from 12 ministries and agencies each carving out their own slice of the budget, and by self-protective regulation driven by fears of personal data leaks.
This criticism is nothing new. The Bank of Korea went so far as to note in a report that Korea has built world-class infrastructure for collecting medical and bio data, yet actual sharing and use remain poor. In effect, high-quality clinical data on 50 million people, obtainable through the national health insurance system, is being left idle. The government has announced plans to build a national integrated bio big data platform covering 770,000 people by 2028, but if it remains fixated on collection while neglecting linkage and processing, that too will end up as just another vast data island.
Advanced economies abroad, by comparison, are pouring everything into data integration and standardization. Governments have taken the lead in writing legislation and committing funds to begin integrating data. The United States enacted the 21st Century Cures Act back in 2016, making the international FHIR API standard mandatory in all commercial electronic medical records, and the National Institutes of Health led a 10-year, $1.45 billion effort to build the All of Us standardization platform.
The European Union, for its part, committed 810 million euros (about 1.2 trillion won) and approved the European Health Data Space regulation. It also required all 27 member states to establish Health Data Access Bodies, allowing pseudonymized information to be linked quickly through a single approval window. Japan completed revisions to its own law in 2023 to expand the use of anonymized data. The change cleared the way for government-approved operators to standardize data from hospitals and medical institutions nationwide so that pharmaceutical companies and others can use it directly.
Global competition in biotech hinges on who can secure high-quality clinical and bio data fastest and turn it into new drugs. With artificial intelligence now in the mix, falling behind is inevitable without data. Korea must shift its paradigm from a policy of collecting data indiscriminately to one of connecting data to new drugs. Applying international standards should be mandatory for every project funded by the government budget, and the share of spending on processing, linkage and standardization must be raised dramatically by cutting budgets for simple collection.
Above all, a way must be found to open and reprocess, for the public good, the clinical data on citizens gathered through the national health insurance system. Building a systematic support framework is essential — one that opens bio and clinical data through a single window, raises the odds that the data will actually be used, and channels it into work such as drug development.
Korea also urgently needs to lay a national data road network, modeled on Britain's Secure Data Environment, where researchers can enter a virtual platform and run analysis safely. If a budget approaching 4 trillion won is not to end up as an ornate relic of bureaucracy, the locks on the data must come off now. Otherwise the future of Korea's pharmaceutical and bio industry will remain uncertain.
