Shall it Be Must or Shall it Be Should? Analysis of How the Term Shall Is Understood and Application to the EU-HTA Regulation

The authors have observed several uninformed discussions in Health Technology Assessment (HTA) forums, conferences and conventions regarding the mandatory or voluntary application of the EU-HTA regulation from both the perspectives of Member States (MS) and health technology developers (HTD). The systematic use of the verb "shall" in the EU HTA regulation has caused confusion among audiences unfamiliar with legal terminology.