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Browse files- index.html +59 -66
index.html
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{ title: "GDPR Art. 30 (RoPA)", url: "https://gdpr-info.eu/art-30-gdpr/" }
|
|
@@ -681,7 +674,7 @@
|
|
| 681 |
},
|
| 682 |
{
|
| 683 |
k: "9h",
|
| 684 |
-
label: "
|
| 685 |
req: false,
|
| 686 |
showFor: ["innovation"],
|
| 687 |
refs: [
|
|
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|
| 127 |
items: [
|
| 128 |
{
|
| 129 |
k: "1a",
|
| 130 |
+
label: "Set pathway & roles (controller/joint).",
|
| 131 |
req: true,
|
| 132 |
refs: [
|
| 133 |
{ title: "GDPR Art. 4 (defs) & Art. 4(7) (controller)", url: "https://gdpr-info.eu/art-4-gdpr/" },
|
|
|
|
| 137 |
},
|
| 138 |
{
|
| 139 |
k: "1b",
|
| 140 |
+
label: "Record data status: personal / special / anonymised.",
|
| 141 |
req: true,
|
| 142 |
refs: [
|
| 143 |
{ title: "GDPR Art. 9(1) (special categories)", url: "https://gdpr-info.eu/art-9-gdpr/" },
|
|
|
|
| 147 |
},
|
| 148 |
{
|
| 149 |
k: "1c",
|
| 150 |
+
label: "Note purpose & apply minimisation.",
|
| 151 |
req: true,
|
| 152 |
refs: [
|
| 153 |
{ title: "GDPR Art. 5(1)(b)-(c) (purpose/minimisation)", url: "https://gdpr-info.eu/art-5-gdpr/" }
|
|
|
|
| 155 |
},
|
| 156 |
{
|
| 157 |
k: "1d",
|
| 158 |
+
label: "If research: check HRA scope; REK decides.",
|
| 159 |
req: true,
|
| 160 |
refs: [
|
| 161 |
{ title: "HRA §2, §4 (scope/defs)", url: "https://lovdata.no/lov/2008-06-20-44/%C2%A72" },
|
|
|
|
| 165 |
},
|
| 166 |
{
|
| 167 |
k: "1e",
|
| 168 |
+
label: "Using registries? Note registry rules.",
|
| 169 |
req: false,
|
| 170 |
refs: [
|
| 171 |
{ title: "HRL (Helseregisterloven)", url: "https://lovdata.no/dokument/NL/lov/2014-06-20-43" }
|
|
|
|
| 174 |
},
|
| 175 |
{
|
| 176 |
k: "1f",
|
| 177 |
+
label: "Get DPO advice; keep rationale.",
|
| 178 |
req: true,
|
| 179 |
refs: [
|
| 180 |
{ title: "GDPR Art. 5(2) (accountability)", url: "https://gdpr-info.eu/art-5-gdpr/" },
|
|
|
|
| 183 |
},
|
| 184 |
{
|
| 185 |
k: "1g",
|
| 186 |
+
label: "DPIA screening (high risk?).",
|
| 187 |
req: true,
|
| 188 |
refs: [
|
| 189 |
{ title: "GDPR Art. 35 (DPIA)", url: "https://gdpr-info.eu/art-35-gdpr/" }
|
|
|
|
| 198 |
items: [
|
| 199 |
{
|
| 200 |
k: "2a",
|
| 201 |
+
label: "Set a legal basic amoung public interest/official authority, research/statistics with safeguards, healthcare/management/QI)",
|
|
|
|
|
|
|
|
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|
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|
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|
|
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|
|
|
|
| 202 |
req: true,
|
| 203 |
refs: [
|
| 204 |
+
{ title: "GDPR Art. 6(1) (lawful basis)", url: "https://gdpr-info.eu/art-6-gdpr/" },
|
| 205 |
{ title: "GDPR Art. 9(2)(h)/(j)", url: "https://gdpr-info.eu/art-9-gdpr/" },
|
| 206 |
{ title: "GDPR Art. 89(1) (safeguards)", url: "https://gdpr-info.eu/art-89-gdpr/" }
|
| 207 |
],
|
| 208 |
},
|
| 209 |
{
|
| 210 |
k: "2c",
|
| 211 |
+
label: "If using consent: valid, informed, withdrawable.",
|
| 212 |
req: false,
|
| 213 |
refs: [
|
| 214 |
{ title: "GDPR Art. 7 (consent)", url: "https://gdpr-info.eu/art-7-gdpr/" },
|
|
|
|
| 218 |
},
|
| 219 |
{
|
| 220 |
k: "2d",
|
| 221 |
+
label: "Health-law confidentiality/dispensation handled.",
|
| 222 |
req: true,
|
| 223 |
refs: [
|
| 224 |
{ title: "HPA §21 (confidentiality)", url: "https://lovdata.no/lov/1999-07-02-64/%C2%A721" },
|
|
|
|
| 228 |
},
|
| 229 |
{
|
| 230 |
k: "2e",
|
| 231 |
+
label: "Non-care record access lawful & logged.",
|
| 232 |
req: true,
|
| 233 |
refs: [
|
| 234 |
{ title: "PRA §22 (security/logging)", url: "https://lovdata.no/lov/2014-06-20-42/%C2%A722" },
|
|
|
|
| 237 |
},
|
| 238 |
{
|
| 239 |
k: "2f",
|
| 240 |
+
label: "Purpose limitation documented.",
|
| 241 |
req: true,
|
| 242 |
refs: [
|
| 243 |
{ title: "GDPR Art. 5(1)(b) (purpose limitation)", url: "https://gdpr-info.eu/art-5-gdpr/" }
|
|
|
|
| 252 |
items: [
|
| 253 |
{
|
| 254 |
k: "3a",
|
| 255 |
+
label: "REK approval/confirmation (before access).",
|
| 256 |
req: true,
|
| 257 |
showFor: ["research"],
|
| 258 |
refs: [
|
|
|
|
| 262 |
},
|
| 263 |
{
|
| 264 |
k: "3b",
|
| 265 |
+
label: "Registry conditions addressed.",
|
| 266 |
req: true,
|
| 267 |
showFor: ["statistics", "research"],
|
| 268 |
refs: [
|
|
|
|
| 272 |
},
|
| 273 |
{
|
| 274 |
k: "3c",
|
| 275 |
+
label: "QI/other: internal governance in place.",
|
| 276 |
req: true,
|
| 277 |
showFor: ["quality", "other"],
|
| 278 |
refs: [
|
|
|
|
| 281 |
},
|
| 282 |
{
|
| 283 |
k: "3d",
|
| 284 |
+
label: "For AI: plan obligations (risk, data, docs, oversight).",
|
| 285 |
req: true,
|
| 286 |
showFor: ["innovation"],
|
| 287 |
refs: [
|
|
|
|
| 290 |
},
|
| 291 |
{
|
| 292 |
k: "3e",
|
| 293 |
+
label: "RoPA & transparency notices ready.",
|
| 294 |
req: true,
|
| 295 |
refs: [
|
| 296 |
{ title: "GDPR Art. 30 (RoPA)", url: "https://gdpr-info.eu/art-30-gdpr/" },
|
|
|
|
| 306 |
items: [
|
| 307 |
{
|
| 308 |
k: "4a",
|
| 309 |
+
label: "Access route confirmed (e.g., Helsedataservice).",
|
| 310 |
req: true,
|
| 311 |
refs: [
|
| 312 |
{ title: "Helsedataservice", url: "https://helsedata.no/" },
|
|
|
|
| 317 |
},
|
| 318 |
{
|
| 319 |
k: "4b",
|
| 320 |
+
label: "Contracts in place (DPA/DSA/DUA; joint/processor).",
|
| 321 |
req: true,
|
| 322 |
refs: [
|
| 323 |
{ title: "GDPR Art. 28(3) (processor contract)", url: "https://gdpr-info.eu/art-28-gdpr/" },
|
|
|
|
| 326 |
},
|
| 327 |
{
|
| 328 |
k: "4c",
|
| 329 |
+
label: "Access control & logging set.",
|
| 330 |
req: true,
|
| 331 |
refs: [
|
| 332 |
{ title: "GDPR Art. 32 (security)", url: "https://gdpr-info.eu/art-32-gdpr/" },
|
|
|
|
| 336 |
},
|
| 337 |
{
|
| 338 |
k: "4d",
|
| 339 |
+
label: "Team confidentiality/training signed.",
|
| 340 |
req: true,
|
| 341 |
refs: [
|
| 342 |
{ title: "HPA §21 (duty of confidentiality)", url: "https://lovdata.no/lov/1999-07-02-64/%C2%A721" }
|
|
|
|
| 344 |
},
|
| 345 |
{
|
| 346 |
k: "4e",
|
| 347 |
+
label: "Secure transfer to analysis environment.",
|
| 348 |
req: true,
|
| 349 |
refs: [
|
| 350 |
{ title: "GDPR Art. 32 (security)", url: "https://gdpr-info.eu/art-32-gdpr/" },
|
|
|
|
| 353 |
},
|
| 354 |
{
|
| 355 |
k: "4f",
|
| 356 |
+
label: "Sharing datasets/AI models lawfully permitted.",
|
| 357 |
req: false,
|
| 358 |
refs: [
|
| 359 |
{ title: "AI Act Art. 2(7) (scope)", url: "https://ai-act-law.eu/article/2/" },
|
|
|
|
| 364 |
},
|
| 365 |
{
|
| 366 |
k: "4g",
|
| 367 |
+
label: "EHDS alignment (if cross-border/secondary use).",
|
| 368 |
req: false,
|
| 369 |
refs: [
|
| 370 |
+
{ title: "EHDS", url: "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202500327" }
|
| 371 |
],
|
| 372 |
},
|
| 373 |
],
|
|
|
|
| 379 |
items: [
|
| 380 |
{
|
| 381 |
k: "5a",
|
| 382 |
+
label: "Pseudonymise; keep keys separate.",
|
| 383 |
req: true,
|
| 384 |
refs: [
|
| 385 |
{ title: "GDPR Art. 4(5) (pseudonymisation)", url: "https://gdpr-info.eu/art-4-gdpr/" }
|
|
|
|
| 387 |
},
|
| 388 |
{
|
| 389 |
k: "5b",
|
| 390 |
+
label: "Encryption, RBAC, MFA, network safeguards, logging.",
|
| 391 |
req: true,
|
| 392 |
refs: [
|
| 393 |
{ title: "GDPR Art. 32 (security)", url: "https://gdpr-info.eu/art-32-gdpr/" },
|
|
|
|
| 397 |
},
|
| 398 |
{
|
| 399 |
k: "5c",
|
| 400 |
+
label: "Derived data protected equally.",
|
| 401 |
req: true,
|
| 402 |
refs: [
|
| 403 |
{ title: "GDPR Art. 5(1)(f); Art. 32", url: "https://gdpr-info.eu/art-5-gdpr/" }
|
|
|
|
| 405 |
},
|
| 406 |
{
|
| 407 |
k: "5d",
|
| 408 |
+
label: "DPIA done/recorded; DPO consulted as needed.",
|
| 409 |
req: true,
|
| 410 |
refs: [
|
| 411 |
{ title: "GDPR Art. 35 (DPIA)", url: "https://gdpr-info.eu/art-35-gdpr/" },
|
|
|
|
| 414 |
},
|
| 415 |
{
|
| 416 |
k: "5e",
|
| 417 |
+
label: "Transfers outside EEA lawful (adequacy/SCC/derog.).",
|
| 418 |
req: true,
|
| 419 |
refs: [
|
| 420 |
{ title: "GDPR Arts. 44–46 (transfers/SCCs)", url: "https://gdpr-info.eu/chapter-5/" },
|
|
|
|
| 423 |
},
|
| 424 |
{
|
| 425 |
k: "5f",
|
| 426 |
+
label: "Vendor/processor DPAs signed.",
|
| 427 |
req: true,
|
| 428 |
refs: [
|
| 429 |
{ title: "GDPR Art. 28 (processors)", url: "https://gdpr-info.eu/art-28-gdpr/" }
|
|
|
|
| 431 |
},
|
| 432 |
{
|
| 433 |
k: "5g",
|
| 434 |
+
label: "Breach plan & notify (72h) if required.",
|
| 435 |
req: true,
|
| 436 |
refs: [
|
| 437 |
{ title: "GDPR Art. 33–34 (breach/notify)", url: "https://gdpr-info.eu/art-33-gdpr/" }
|
|
|
|
| 439 |
},
|
| 440 |
{
|
| 441 |
k: "5h",
|
| 442 |
+
label: "Periodic security review.",
|
| 443 |
req: true,
|
| 444 |
refs: [],
|
| 445 |
},
|
|
|
|
| 452 |
items: [
|
| 453 |
{
|
| 454 |
k: "6a",
|
| 455 |
+
label: "Extract only necessary/approved fields.",
|
| 456 |
req: true,
|
| 457 |
refs: [
|
| 458 |
{ title: "GDPR Art. 5(1)(b)-(c)", url: "https://gdpr-info.eu/art-5-gdpr/" }
|
|
|
|
| 460 |
},
|
| 461 |
{
|
| 462 |
k: "6b",
|
| 463 |
+
label: "Sweep extracts for unexpected content.",
|
| 464 |
req: true,
|
| 465 |
refs: [
|
| 466 |
{ title: "GDPR Art. 5(1)(c); Art. 25", url: "https://gdpr-info.eu/art-25-gdpr/" }
|
|
|
|
| 468 |
},
|
| 469 |
{
|
| 470 |
k: "6c",
|
| 471 |
+
label: "For AI: bias audits & data governance.",
|
| 472 |
req: true,
|
| 473 |
showFor: ["innovation"],
|
| 474 |
refs: [
|
|
|
|
| 478 |
},
|
| 479 |
{
|
| 480 |
k: "6d",
|
| 481 |
+
label: "Plan periodic data quality reviews.",
|
| 482 |
req: true,
|
| 483 |
refs: [
|
| 484 |
{ title: "GDPR Art. 5(1)(d) (accuracy); Art. 5(2)", url: "https://gdpr-info.eu/art-5-gdpr/" }
|
|
|
|
| 493 |
items: [
|
| 494 |
{
|
| 495 |
k: "7a",
|
| 496 |
+
label: "Use validated tools; no re-ID unless authorised.",
|
| 497 |
req: true,
|
| 498 |
refs: [
|
| 499 |
{ title: "GDPR Art. 5(1)(a)-(b)", url: "https://gdpr-info.eu/art-5-gdpr/" }
|
|
|
|
| 501 |
},
|
| 502 |
{
|
| 503 |
k: "7b",
|
| 504 |
+
label: "Keep preprocessing & tech docs/records.",
|
| 505 |
req: true,
|
| 506 |
refs: [
|
| 507 |
{ title: "AI Act Art. 10 (data); Art. 11 (tech docs); Art. 12 (records)", url: "https://ai-act-law.eu/article/10/" },
|
|
|
|
| 513 |
},
|
| 514 |
{
|
| 515 |
k: "7c",
|
| 516 |
+
label: "AI risk classification documented.",
|
| 517 |
req: true,
|
| 518 |
showFor: ["innovation"],
|
| 519 |
refs: [
|
|
|
|
| 523 |
},
|
| 524 |
{
|
| 525 |
k: "7d",
|
| 526 |
+
label: "High-risk: controls, oversight, validation, cybersecurity.",
|
| 527 |
req: true,
|
| 528 |
showFor: ["innovation"],
|
| 529 |
refs: [
|
|
|
|
| 532 |
},
|
| 533 |
{
|
| 534 |
k: "7e",
|
| 535 |
+
label: "Non-high-risk: good practice / voluntary codes.",
|
| 536 |
req: false,
|
| 537 |
showFor: ["innovation"],
|
| 538 |
refs: [
|
|
|
|
| 541 |
},
|
| 542 |
{
|
| 543 |
k: "7f",
|
| 544 |
+
label: "If placing on EU market: conformity/CE/AI DB.",
|
| 545 |
req: false,
|
| 546 |
showFor: ["innovation"],
|
| 547 |
refs: [
|
|
|
|
| 550 |
},
|
| 551 |
{
|
| 552 |
k: "7g",
|
| 553 |
+
label: "Bias mitigation & fairness checks documented.",
|
| 554 |
req: true,
|
| 555 |
showFor: ["innovation"],
|
| 556 |
refs: [
|
|
|
|
| 560 |
},
|
| 561 |
{
|
| 562 |
k: "7h",
|
| 563 |
+
label: "Plan periodic reassessment/review.",
|
| 564 |
req: true,
|
| 565 |
refs: [],
|
| 566 |
},
|
|
|
|
| 573 |
items: [
|
| 574 |
{
|
| 575 |
k: "8a",
|
| 576 |
+
label: "Internal audit done; issues remediated.",
|
| 577 |
req: true,
|
| 578 |
refs: [
|
| 579 |
{ title: "GDPR Art. 5(2) (accountability); Art. 24", url: "https://gdpr-info.eu/art-24-gdpr/" }
|
|
|
|
| 581 |
},
|
| 582 |
{
|
| 583 |
k: "8b",
|
| 584 |
+
label: "Maintain compliance report (docs/approvals).",
|
| 585 |
req: true,
|
| 586 |
refs: [],
|
| 587 |
},
|
| 588 |
{
|
| 589 |
k: "8c",
|
| 590 |
+
label: "Source-system extractions logged; periodic log review.",
|
| 591 |
req: true,
|
| 592 |
refs: [
|
| 593 |
{ title: "PRA §22; PRR §14; Normen 5.4.4", url: "https://lovdata.no/forskrift/2019-03-01-168/%C2%A714" }
|
|
|
|
| 595 |
},
|
| 596 |
{
|
| 597 |
k: "8d",
|
| 598 |
+
label: "Use only within approvals; amend before new use.",
|
| 599 |
req: true,
|
| 600 |
refs: [
|
| 601 |
{ title: "GDPR Art. 5(1)(b) (purpose); HRA §33", url: "https://gdpr-info.eu/art-5-gdpr/" }
|
|
|
|
| 603 |
},
|
| 604 |
{
|
| 605 |
k: "8e",
|
| 606 |
+
label: "Periodically update audit/compliance process.",
|
| 607 |
req: true,
|
| 608 |
refs: [],
|
| 609 |
},
|
|
|
|
| 616 |
items: [
|
| 617 |
{
|
| 618 |
k: "9a",
|
| 619 |
+
label: "Disclosure control OK (no IDs in outputs).",
|
| 620 |
req: true,
|
| 621 |
refs: [
|
| 622 |
{ title: "GDPR Art. 5(1)(c); Art. 89(1)", url: "https://gdpr-info.eu/art-89-gdpr/" }
|
|
|
|
| 624 |
},
|
| 625 |
{
|
| 626 |
k: "9b",
|
| 627 |
+
label: "Publications: ethics/DP statements; AI transparency.",
|
| 628 |
req: false,
|
| 629 |
refs: [
|
| 630 |
{ title: "AI Act Art. 13 (transparency)", url: "https://ai-act-law.eu/article/13/" }
|
|
|
|
| 632 |
},
|
| 633 |
{
|
| 634 |
k: "9c",
|
| 635 |
+
label: "Required reports submitted (REK/registries/AI DB).",
|
| 636 |
req: false,
|
| 637 |
refs: [
|
| 638 |
{ title: "AI Act Chapter III (registering duties)", url: "https://ai-act-law.eu/chapter/3/" }
|
|
|
|
| 640 |
},
|
| 641 |
{
|
| 642 |
k: "9d",
|
| 643 |
+
label: "Delete/anonymise at retention end; document.",
|
| 644 |
req: true,
|
| 645 |
refs: [
|
| 646 |
{ title: "GDPR Art. 5(1)(e); Art. 5(2)", url: "https://gdpr-info.eu/art-5-gdpr/" }
|
|
|
|
| 648 |
},
|
| 649 |
{
|
| 650 |
k: "9e",
|
| 651 |
+
label: "Archive key docs securely (no raw IDs).",
|
| 652 |
req: true,
|
| 653 |
refs: [
|
| 654 |
{ title: "GDPR Art. 5(1)(e); Art. 89(1)", url: "https://gdpr-info.eu/art-89-gdpr/" }
|
|
|
|
| 656 |
},
|
| 657 |
{
|
| 658 |
k: "9f",
|
| 659 |
+
label: "If retain/reuse: set new legal basis/approvals.",
|
| 660 |
req: true,
|
| 661 |
refs: [
|
| 662 |
{ title: "GDPR Art. 6(1); Art. 9(2)", url: "https://gdpr-info.eu/art-6-gdpr/" },
|
|
|
|
| 666 |
},
|
| 667 |
{
|
| 668 |
k: "9g",
|
| 669 |
+
label: "Final debrief; notify closure; update RoPA.",
|
| 670 |
req: true,
|
| 671 |
refs: [
|
| 672 |
{ title: "GDPR Art. 30 (RoPA)", url: "https://gdpr-info.eu/art-30-gdpr/" }
|
|
|
|
| 674 |
},
|
| 675 |
{
|
| 676 |
k: "9h",
|
| 677 |
+
label: "If AI continues: monitor; if stopped: purge artifacts.",
|
| 678 |
req: false,
|
| 679 |
showFor: ["innovation"],
|
| 680 |
refs: [
|