Software as a Medical Device
Second Edition
xii Regulatory Affairs Professionals Society
ISO/IEC .................................................................................................................................................................................171
IEEE. .......................................................................................................................................................................................172
CTA. ........................................................................................................................................................................................172
Data Management in Practice.......................................................................................................................................................173
Cloud, Self-Hosting, or Managed Hosting. .............................................................................................................................173
Data Register............................................................................................................................................................................173
Data Expiration Policies...........................................................................................................................................................173
Traceability and Identification..................................................................................................................................................174
PII, PHI, Pseudonymization, Anonymization..........................................................................................................................175
Data Breaches...........................................................................................................................................................................175
Conclusion. ...................................................................................................................................................................................175
Chapter 14: Digital Supply Chains and Their Regulatory Implications. ...........................................................................179
Koen Cobbaert, MSc
Introduction. .................................................................................................................................................................................179
Digital Distribution and Supply-Chain Accountability. ...............................................................................................................179
Horizontal Digital Rules in the Medical Device Supply Chain....................................................................................................179
Regulatory Trigger Points: Placing on the Market Versus Putting Into Service............................................................................180
Why Definitions Matter: Legislative Scope and Operator Responsibilities..................................................................................181
Physical Supply Chains and Regulatory Trigger Points. ...............................................................................................................182
Labeling and Traceability Obligations for Software on Physical Media. ......................................................................................182
Digital Supply Chains and Governance. .......................................................................................................................................182
Digital Supply Chains and Regulatory Trigger Points. .................................................................................................................182
Distance Sales................................................................................................................................................................................183
Information Society Services.........................................................................................................................................................183
When Software Breaks the Sequence: Updates and Modules.......................................................................................................183
Use Case 1 – Hardware With Embedded Software (Integrated Product)................................................................................184
Use Case 2 – Separate Hardware and Software Integrated at Installation. ..............................................................................185
Use Case 3 – Independent Software (Software-Only Offering)...............................................................................................186
Economic Operators in Traditional Supply Chains.......................................................................................................................187
Economic Operators in Digital Supply Chains.............................................................................................................................191
Importer and Distributor Obligations......................................................................................................................................192
Online Platform Provider Obligations. ....................................................................................................................................194
Gatekeeper Obligations............................................................................................................................................................197
Deployer Obligations. ..............................................................................................................................................................198
Conclusion. ...................................................................................................................................................................................198
Author Acknowledgment..............................................................................................................................................................198
Chapter 15: Market Access and Reimbursement Pathways for Digital Health Technologies..............................................201
Catarina Carrão, FAHA
Introduction .................................................................................................................................................................................201
Market Authorization Versus Market Access................................................................................................................................201
Coverage and Health Technology Assessment (HTA)..................................................................................................................202
Specifics of Reimbursement Pathways for DHTs Across EU Member States. ........................................................................203
Health Technology Assessment (HTA) Regulation, EDiHTA, and ASSESS-DHT...................................................................206
Outside of the EU Member States: Global Reimbursement Landscape.......................................................................................207
UK ...........................................................................................................................................................................................207
South Korea .............................................................................................................................................................................207
Japan ........................................................................................................................................................................................207
US ...........................................................................................................................................................................................207
Conclusion. ...................................................................................................................................................................................208
Chapter 16: Software Liability. ......................................................................................................................................211
Agnes Szoboszlai, LLM, and Uta Rawson, JD
Introduction. .................................................................................................................................................................................211
Product Liability............................................................................................................................................................................211
Software as a Product. ..............................................................................................................................................................212
Second Edition
xii Regulatory Affairs Professionals Society
ISO/IEC .................................................................................................................................................................................171
IEEE. .......................................................................................................................................................................................172
CTA. ........................................................................................................................................................................................172
Data Management in Practice.......................................................................................................................................................173
Cloud, Self-Hosting, or Managed Hosting. .............................................................................................................................173
Data Register............................................................................................................................................................................173
Data Expiration Policies...........................................................................................................................................................173
Traceability and Identification..................................................................................................................................................174
PII, PHI, Pseudonymization, Anonymization..........................................................................................................................175
Data Breaches...........................................................................................................................................................................175
Conclusion. ...................................................................................................................................................................................175
Chapter 14: Digital Supply Chains and Their Regulatory Implications. ...........................................................................179
Koen Cobbaert, MSc
Introduction. .................................................................................................................................................................................179
Digital Distribution and Supply-Chain Accountability. ...............................................................................................................179
Horizontal Digital Rules in the Medical Device Supply Chain....................................................................................................179
Regulatory Trigger Points: Placing on the Market Versus Putting Into Service............................................................................180
Why Definitions Matter: Legislative Scope and Operator Responsibilities..................................................................................181
Physical Supply Chains and Regulatory Trigger Points. ...............................................................................................................182
Labeling and Traceability Obligations for Software on Physical Media. ......................................................................................182
Digital Supply Chains and Governance. .......................................................................................................................................182
Digital Supply Chains and Regulatory Trigger Points. .................................................................................................................182
Distance Sales................................................................................................................................................................................183
Information Society Services.........................................................................................................................................................183
When Software Breaks the Sequence: Updates and Modules.......................................................................................................183
Use Case 1 – Hardware With Embedded Software (Integrated Product)................................................................................184
Use Case 2 – Separate Hardware and Software Integrated at Installation. ..............................................................................185
Use Case 3 – Independent Software (Software-Only Offering)...............................................................................................186
Economic Operators in Traditional Supply Chains.......................................................................................................................187
Economic Operators in Digital Supply Chains.............................................................................................................................191
Importer and Distributor Obligations......................................................................................................................................192
Online Platform Provider Obligations. ....................................................................................................................................194
Gatekeeper Obligations............................................................................................................................................................197
Deployer Obligations. ..............................................................................................................................................................198
Conclusion. ...................................................................................................................................................................................198
Author Acknowledgment..............................................................................................................................................................198
Chapter 15: Market Access and Reimbursement Pathways for Digital Health Technologies..............................................201
Catarina Carrão, FAHA
Introduction .................................................................................................................................................................................201
Market Authorization Versus Market Access................................................................................................................................201
Coverage and Health Technology Assessment (HTA)..................................................................................................................202
Specifics of Reimbursement Pathways for DHTs Across EU Member States. ........................................................................203
Health Technology Assessment (HTA) Regulation, EDiHTA, and ASSESS-DHT...................................................................206
Outside of the EU Member States: Global Reimbursement Landscape.......................................................................................207
UK ...........................................................................................................................................................................................207
South Korea .............................................................................................................................................................................207
Japan ........................................................................................................................................................................................207
US ...........................................................................................................................................................................................207
Conclusion. ...................................................................................................................................................................................208
Chapter 16: Software Liability. ......................................................................................................................................211
Agnes Szoboszlai, LLM, and Uta Rawson, JD
Introduction. .................................................................................................................................................................................211
Product Liability............................................................................................................................................................................211
Software as a Product. ..............................................................................................................................................................212