Karsten, It is the opinion of the Applied Technical Research Institute (TNO-PG), I work for, after having studied European law and Dutch law that possibly the only legally valid proof is a signed 'picture' of what was shown on the screen. E.g. A prescription, an order, a referral. Next to the information formally submitted into the EHR their will be a whole gamut of other secondary information: private notes, not evaluated results and opinions. This 'picture' could be generated from information in a database. Why a 'picture'? Not only the stored information is information; the way it is presented is information as well. How can one be sure that what is stored in the database is what has been presented visibly on the screen? (black characters on a black background, information hidden behind on other window, etc)
The question open for debate is: what is this 'picture'? Is it a PDF? Is it Microsoft Word? Is it data in a XML-Document plus the style sheet used? Is it ...? What a signature is and what a signed document is, is more clear in Europe. All this is part of the TNO-PG Essential Requirements for the EHR. Only systems that comply will fulfil all basic requirements as expressed by European Directives and Dutch law (that is derived from these Directives) Gerard Helas. Copies of these Essential Requirements are not available for publication, yet. It is a difficult complex document that is being revised and improved all the time. Until it has been transformed into a usable and easy readable format we only have copies for internal use and for our customers that want to have their products approved. It is our goal to present them to the ISO/TC215 community in due time for consideration. On 14-09-2002 10:19, "Karsten Hilbert" <Karsten.Hilbert at gmx.net> wrote: >> So an EHR is a series of signed, authored messages that can be used in >> court. Without the fulfillment of the requirements, the EHR is nothing but >> information written in the sand before a wave of the sea washes it away. > This is, however, the way medicine worked for thousands of > years, and reasonably well, obviously. It is trust that > defines the doctor-patient relationship, not proof. > >> What an application does with the information on a screen and in its >> database is much less relevant from a legal perspective. >> What is signed is relevant. > Are you suggesting applications should store digitally signed > screenshots ? > > Regards, > > Karsten Hilbert, MD > GnuMed i18n coordinator -- <private> -- Gerard Freriks, arts Huigsloterdijk 378 2158 LR Buitenkaag The Netherlands +31 252 544896 +31 654 792800 - If you have any questions about using this list, please send a message to d.lloyd at openehr.org
