[
{
"regulation": "EHDS",
"sector": "healthcare",
"subsector": null,
"applies": true,
"confidence": "definite",
"basis_article": "1",
"notes": "EHDS establishes the European Health Data Space for primary and secondary use of health data"
},
{
"regulation": "EHDS",
"sector": "healthcare",
"subsector": "hospitals",
"applies": true,
"confidence": "definite",
"basis_article": "2",
"notes": "Healthcare providers must make health data accessible via EHR systems"
},
{
"regulation": "EHDS",
"sector": "healthcare",
"subsector": "pharmaceuticals",
"applies": true,
"confidence": "definite",
"basis_article": "1",
"notes": "Applies to entities developing products for healthcare sector"
},
{
"regulation": "EHDS",
"sector": "digital_infrastructure",
"subsector": "health_tech",
"applies": true,
"confidence": "definite",
"basis_article": "2",
"notes": "EHR system manufacturers and wellness app developers are covered"
},
{
"regulation": "EHDS",
"sector": "financial",
"subsector": "insurance",
"applies": true,
"confidence": "likely",
"basis_article": "2",
"notes": "Health insurers may be health data holders for reimbursement purposes"
},
{
"regulation": "EHDS",
"sector": "public_administration",
"subsector": null,
"applies": true,
"confidence": "definite",
"basis_article": "1",
"notes": "Public health authorities are key participants in EHDS infrastructure"
},
{
"regulation": "EHDS",
"sector": "manufacturing",
"subsector": null,
"applies": false,
"confidence": "definite",
"basis_article": "1",
"notes": "General manufacturing not in scope unless producing medical/health products"
},
{
"regulation": "EHDS",
"sector": "other",
"subsector": "research",
"applies": true,
"confidence": "definite",
"basis_article": "1",
"notes": "Research organizations can access health data for secondary use under EHDS"
}
]
