Background: Modern rapid microdiagnostic technologies, which have inbuilt capacity to send data through mobile phone networks (as being developed within eSTI2; eSTI2.org.uk) will enable accurate self and home testing for sexually transmitted infections (STIs) and are well suited to online medical management. However, no UK specific regulatory guidance exists for such online clinical care pathways. Objective: to develop an automated online clinical consultation, meeting existing regulatory and legal requirements, which takes people from diagnosis of chlamydia, through clinical assessment, leading to electronic prescription and partner management.
Methods: 1. Review of legislation, regulations, ethical and perceptual barriers to introducing online clinical care pathways in the UK National Health Service; 2.development of a framework to subdivide the pathway into functional units against which legal and regulatory findings were mapped; 3.development of a prototype care pathway; 4.refinement through an iterative process of expert and user review and comprehension testing.
Results: Six key functional units form the online clinical care pathway: diagnosis, history taking, decision support, e-prescribing, information exchange and electronic health records. Within this framework, the automated, online clinical consultation includes risk assessment of sexual behaviour; assessment of safety of prescribing; antibiotic collection from a community pharmacy; and partner referral and epidemiological treatment. A linked telephone helpline supports people with complex medical and psychological needs. We believe we meet current regulatory and legal guidance
Conclusions: It is possible to develop an online clinical consultation, using robust methods of review, pathway design and testing. In the UK existing legal and regulatory guidance lags behind advances in diagnostic technologies, presenting challenges to adoption of innovation particularly in relation to online management and remote prescribing for STIs. Our pathway will be tested as part of an exploratory trial in 2014. The methodology described has potential for application to different conditions suited to remote care.