Archetype ontology

2002-09-17 Thread Sam Heard
Hello all

This is a useful discussion - I am much more with Karsten than Gerard on
this - all the 'proofs' in the world amount to nothing in the digital
world - as things can be altered at any point anyway. The GnuMed trust
solution does get someway towards this.

The technical solutions offered at the moment really do not match the
reality and until we have working EHR systems and integration, these sorts
of debate need to stay in the background. They do not really impinge greatly
on the EHR requirements.

But keep it up!

Sam Heard

 -Original Message-
 From: owner-openehr-technical at openehr.org
 [mailto:owner-openehr-technical at openehr.org]On Behalf Of Karsten Hilbert
 Sent: Sunday, 15 September 2002 6:57 PM
 To: Gerard Freriks
 Cc: David Guest; Openehr-Technical; Ton Smit
 Subject: Re: Archetype ontology


 1) How do I know that the passphrase I typed in to be used for
   the secret key is used to sign what I see on screen and
   nothing else ?

 2) How does the court know that a signed screenshot was
actually shown on screen and not just fabricated and never
shown ? (It is my responsibility to _inspect_ what is being
shown but I cannot prove that signed screenshots were
actually displayed (on current-day systems).

 This isn't about 100% proof, this is about level of trust,
 feasability, deniability and due process. Even with signing
 screenshots.

 Or did I miss something ?

 Since it is my responsiblity to carefully inspect the
 on-screen information I could just as well extend that view to
 that it is my responsibility to use a system that I can trust
 to show me what is actually in the database. Thusly I could
 just as well sign database content. Gerard himself remarked
 that we cannot sign that anyone actually reviewed any
 information, only that it was made available. The latter can
 be at the level of a screenshot - or at the level of database
 content. After all it is my responsibility to inform myself
 no matter where I get the information from. Say, I am using an
 SQL shell and sign screenshots of my queries. Does this mean I
 am not liable for the anaphylactic reaction just because I
 didn't do the query for the known penicillin allergy ?!?
 Obviously not, although I understand your position to be: It
 hasn't been shown to me hence I am not to blame. What other
 purpose might a signed screenshot server ? To shift blame to
 the EHR software manufacturer ?

 Lastly, one simple question. How does TNO propose to handle
 the audit trail of signed screenshots simply in terms of
 storage requirements ?

  Making a hash of a screen dump indicates: This is the
 information as I saw
  it on a screen and take responsibility for it by signing.
 Nah, I doubt you really believe in the coherency of this
 statement. A screendump merely shows what a screen _may_ have
 looked like.

 Karsten Hilbert
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 E167 67FD A291 2BEA 73BD  4537 78B9 A9F9 E407 1346
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Archetype ontology

2002-09-16 Thread Sam Heard
Karsten

I do not go with the screen shot idea - the issue here is the accountability
and if the information is stored in an explicit manner and the rendition can
be stored (XSLT or application) then it will be clear what the person saw -
the problem with screenshots is the plethora of views that might be used in
a single consultation. And can we be sure that the screen was paged down?
And what was the resolution of the screen - and the visual acuity of the
practitioner - and what parts of the screen did their eyes stray to...

Our research in GEHR had a clear outcome - clinicians did not want this sort
of EHR and it served no useful purpose.

Cheers, Sam

Dr Sam Heard
The Good Electronic Health Record
Ocean Informatics, openEHR
105 Rapid Creek Rd
Rapid Creek NT 0810
Ph: +61 417 838 808
sam.heard at bigpond.com
www.gehr.org
www.openEHR.org
__



 -Original Message-
 From: Karsten Hilbert [mailto:Karsten.Hilbert at gmx.net]
 Sent: Saturday, 14 September 2002 5:49 PM
 To: Gerard Freriks
 Cc: Melvin Reynolds; Thomas Beale; William Hammond; Sam Heard;
 Openehr-Technical
 Subject: Re: Archetype ontology


  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
 --
 GPG key ID E4071346 @ wwwkeys.pgp.net
 E167 67FD A291 2BEA 73BD  4537 78B9 A9F9 E407 1346

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Archetype ontology

2002-09-16 Thread Andrew Goodchild

Hi All,

I am rather late to this thread, but it seems to me that there are a
number of alternatives here:

a) Do nothing
b) Have a reasonably secure system, but no signing
c) Sign the content in the database
d) Sign what was on the screen and store the signed image

You can spend all day arguing about which one to adopt, but the reaility
is the is no one true answer to this as it is all horses for courses. In
an evnrionment where everyone is trustworthy or the conseuqneces of
violation are low then (a) is an option. In some environments where the
system administrators and developers can be trusted then option (b) is
enough. In other environments where no one can be trusted then even (d)
might not be enough.

What you need to do is tailor your choice of what you sign (or even if you
sign anything) based on the potential risks and the consequences if
that risk occurs and wether you are willing to spend the money to prevent
it from occurring.

cheers, Andrew


On Sun, 15 Sep 2002, Gerard Freriks wrote:

 On 15-09-2002 11:26, Karsten Hilbert Karsten.Hilbert at gmx.net wrote:

  1) How do I know that the passphrase I typed in to be used for
  the secret key is used to sign what I see on screen and
  nothing else ?
 

 Because a special secure device does all the encrypting.
 After having inserted the Health professional Card


 
  2) How does the court know that a signed screenshot was
   actually shown on screen and not just fabricated and never
   shown ? (It is my responsibility to _inspect_ what is being
   shown but I cannot prove that signed screenshots were
   actually displayed (on current-day systems).
 

 Because the secure device is able to place the information on the screen.

 Having a screenshot provides a richer picture than a set of bits and bytes
 down deep in the database.



  This isn't about 100% proof, this is about level of trust,
  feasability, deniability and due process. Even with signing
  screenshots.
  

 True.
 I'll have more confidence in a message displayed on a screen than bits and
 bytes in a distributed database in an Health Information Infrastructure


  Or did I miss something ?
 
  Since it is my responsiblity to carefully inspect the
  on-screen information I could just as well extend that view to
  that it is my responsibility to use a system that I can trust
  to show me what is actually in the database. Thusly I could
  just as well sign database content. Gerard himself remarked
  that we cannot sign that anyone actually reviewed any
  information, only that it was made available. The latter can
  be at the level of a screenshot - or at the level of database
  content. After all it is my responsibility to inform myself
  no matter where I get the information from. Say, I am using an
  SQL shell and sign screenshots of my queries. Does this mean I
  am not liable for the anaphylactic reaction just because I
  didn't do the query for the known penicillin allergy ?!?
  Obviously not, although I understand your position to be: It
  hasn't been shown to me hence I am not to blame. What other
  purpose might a signed screenshot server ? To shift blame to
  the EHR software manufacturer ?
 

 The whole thing has to do with liability and legal proof.

 If next to the information in a database the style sheet used to display is
 stored, it is possibly good enough for legal proofs.

  Lastly, one simple question. How does TNO propose to handle
  the audit trail of signed screenshots simply in terms of
  storage requirements ?
  

 This is a simple problem.
 Now every year one hospital needs 1 kilometre of shelf space.

 Have you ever compressed XML documents?
 Have you ever looked at diskspace and prices?


  Making a hash of a screen dump indicates: This is the information as I saw
  it on a screen and take responsibility for it by signing.
  Nah, I doubt you really believe in the coherency of this
  statement. A screendump merely shows what a screen _may_ have
  looked like.
  

 I think it is fully coherent.

 Yes. But systems that have been certified will have a perfect screendump.
 This is something that can be tested easily.

 To proof that in a distributed environment all informationsystems worked
 100% is much more difficult?
 Right? Or wrong?

 Gerard



  Karsten Hilbert

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 Gerard Freriks, arts
 Huigsloterdijk 378
 2158 LR Buitenkaag
 The Netherlands

 +31 252 544896
 +31 654 792800


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Archetype ontology

2002-09-16 Thread Thomas Beale


Andrew Goodchild wrote:

Hi All,

I am rather late to this thread, but it seems to me that there are a
number of alternatives here:

a) Do nothing
b) Have a reasonably secure system, but no signing
c) Sign the content in the database
d) Sign what was on the screen and store the signed image

You can spend all day arguing about which one to adopt, but the reaility
is the is no one true answer to this as it is all horses for courses. In
an evnrionment where everyone is trustworthy or the conseuqneces of
violation are low then (a) is an option. In some environments where the
system administrators and developers can be trusted then option (b) is
enough. In other environments where no one can be trusted then even (d)
might not be enough.

What you need to do is tailor your choice of what you sign (or even if you
sign anything) based on the potential risks and the consequences if
that risk occurs and wether you are willing to spend the money to prevent
it from occurring.

I think this is a good overall comment. To which I'll add that what 
needs to be shown to have been understood in court are simple clinical 
or other facts, in the form of propositions, not screen bit patterns. In 
court, it will nee to be shown that that clinician understood fact A, B 
and C before attesting the addition to the EHR. Screen shots are not the 
way to do this. I suggest that a standardised XML rendition of the EHR 
entries in question are the way to go.

Also, we should be careful to differentiate between attestation - the 
act of the clinician agreeing that he/she has in fact seen and 
understood what is on the screen be fore committing it to the EHR, and 
signing which is an attestation that some lump of content was created 
by a certain person, and not someone else. I don't think signing 
guarantees anything about comprehension, just that a particular stream 
of bytes emanated from a source which is positively identified as Dr 
so-and-so.

- thomas beale



cheers, Andrew


On Sun, 15 Sep 2002, Gerard Freriks wrote:

On 15-09-2002 11:26, Karsten Hilbert Karsten.Hilbert at gmx.net wrote:

1) How do I know that the passphrase I typed in to be used for
the secret key is used to sign what I see on screen and
nothing else ?

Because a special secure device does all the encrypting.
After having inserted the Health professional Card


2) How does the court know that a signed screenshot was
 actually shown on screen and not just fabricated and never
 shown ? (It is my responsibility to _inspect_ what is being
 shown but I cannot prove that signed screenshots were
 actually displayed (on current-day systems).

Because the secure device is able to place the information on the screen.

Having a screenshot provides a richer picture than a set of bits and bytes
down deep in the database.



This isn't about 100% proof, this is about level of trust,
feasability, deniability and due process. Even with signing
screenshots.

True.
I'll have more confidence in a message displayed on a screen than bits and
bytes in a distributed database in an Health Information Infrastructure


Or did I miss something ?

Since it is my responsiblity to carefully inspect the
on-screen information I could just as well extend that view to
that it is my responsibility to use a system that I can trust
to show me what is actually in the database. Thusly I could
just as well sign database content. Gerard himself remarked
that we cannot sign that anyone actually reviewed any
information, only that it was made available. The latter can
be at the level of a screenshot - or at the level of database
content. After all it is my responsibility to inform myself
no matter where I get the information from. Say, I am using an
SQL shell and sign screenshots of my queries. Does this mean I
am not liable for the anaphylactic reaction just because I
didn't do the query for the known penicillin allergy ?!?
Obviously not, although I understand your position to be: It
hasn't been shown to me hence I am not to blame. What other
purpose might a signed screenshot server ? To shift blame to
the EHR software manufacturer ?

The whole thing has to do with liability and legal proof.

If next to the information in a database the style sheet used to display is
stored, it is possibly good enough for legal proofs.

Lastly, one simple question. How does TNO propose to handle
the audit trail of signed screenshots simply in terms of
storage requirements ?

This is a simple problem.
Now every year one hospital needs 1 kilometre of shelf space.

Have you ever compressed XML documents?
Have you ever looked at diskspace and prices?


Making a hash of a screen dump indicates: This is the information as I saw
it on a screen and take responsibility for it by signing.

Nah, I doubt you really believe in the coherency of this
statement. A screendump merely shows what a screen _may_ have
looked like.

I think it is fully coherent.

Yes. But systems that have been certified will have a perfect screendump.

Archetype ontology

2002-09-16 Thread Gerard Freriks
On 16-09-2002 03:03, Thomas Beale thomas at deepthought.com.au wrote:

 I think this is a good overall comment. To which I'll add that what
 needs to be shown to have been understood in court are simple clinical
 or other facts, in the form of propositions, not screen bit patterns. In
 court, it will nee to be shown that that clinician understood fact A, B
 and C before attesting the addition to the EHR. Screen shots are not the
 way to do this. I suggest that a standardised XML rendition of the EHR
 entries in question are the way to go.
 
 Also, we should be careful to differentiate between attestation - the
 act of the clinician agreeing that he/she has in fact seen and
 understood what is on the screen be fore committing it to the EHR, and
 signing which is an attestation that some lump of content was created
 by a certain person, and not someone else. I don't think signing
 guarantees anything about comprehension, just that a particular stream
 of bytes emanated from a source which is positively identified as Dr
 so-and-so.
 

Slowly we are making progress.
I agree that there are several reasons to sign and possibly we need ways to
indicate this.
I agree that there are several contexts. The lonely healthcare provider on
his IT island, the one that exchanges information with a few other
colleagues, the healthcare providers that are part of a complex network for
the exchange of messages, the ones that are part of an higly integrated
system of systems. The more complex the more detail has to be stored
explicitly.
I agree that 'screenshots', 'pictures' can be engineered in several ways.
The most likely candidate is XML-document and XML-stylesheet. But perhaps
there are others.


Gerard

Ps: sorry for having an extemist view.



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Huigsloterdijk 378
2158 LR Buitenkaag
The Netherlands

+31 252 544896
+31 654 792800


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Archetype ontology

2002-09-16 Thread Karsten Hilbert
 Lastly, one simple question. How does TNO propose to handle
 the audit trail of signed screenshots simply in terms of
 storage requirements ?
 
 This is a simple problem.
 Now every year one hospital needs 1 kilometre of shelf space.
Well, the treeware equivalent of what we are talking about
here is: Any time I look at the paper chart I'll make a copy
of the page I look at, date and sign it and add it to the
ever-growing chart, e.g. any time I invoke a screen I should
need to sign what I saw, right ?

 Have you ever compressed XML documents?
I thought we were talking screenshots here ? Binary data ?
Already compressed ?

 Have you ever looked at diskspace and prices?
Yes, and I have looked at my salary. I am talking GP level
here.

 Making a hash of a screen dump indicates: This is the information as I saw
 it on a screen and take responsibility for it by signing.
 Nah, I doubt you really believe in the coherency of this
 statement. A screendump merely shows what a screen _may_ have
 looked like.
 I think it is fully coherent.
Are you telling me you mean a signed hash of a screendump
proves that I saw the screendump ?!?

 To proof that in a distributed environment all informationsystems worked
 100% is much more difficult?
 Right? Or wrong?
Right.

Karsten Hilbert
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E167 67FD A291 2BEA 73BD  4537 78B9 A9F9 E407 1346
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Archetype ontology

2002-09-15 Thread David Guest
On Sat, 2002-09-14 at 23:29, Gerard Freriks wrote:
 Text as pointers or URL's it is all fine with me.
 But he signes what he sees.

I think I've got it, Gerard. What are you signing is that a certain
dataset was available to you on a particular day for a particular
patient. You are not signing that you have understood or even looked at
it but that it was available. 

Wouldn't a hash of the data be both smaller and a more reliable
attestation of the data available?

David 


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GPG key ID BE79B742 @ pgp.mit.edu
Fingerprint: 2609 DB95 C040 5902 BA0C  4D3C F1F2 EA62 BE79 B742
-- next part --
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Archetype ontology

2002-09-15 Thread Thomas Beale


Melvin Reynolds wrote:

 Once again I agree (mostly!) - and certainly did not want to imply 
 different levels of medico-legal requirement within any particular 
 jurisdiction.
 The integrated healthcare record is very usefully regarded as a single 
 repository which contains, either directly or by reference, all the 
 data that relates to the process of actually clinical care (not the 
 facilitating aspects of the healthcare infrastructure*) - but upon 
 which there are appropriate views according to the use context.  
 However, the difficulty I have is with the throwaway statements 
 (perhaps just intended as 'shorthand' but if so not sufficiently 
 specific to be helpful at this stage of development and email 
 communication) which if taken literally will result in flawed design:

 generally not come from messages - there is no other place for this 
 data to come from but the GP application
 generally and there is no other place is the problem here, often 
 would be more accurate because, as an example, the giving of 
 vaccinations to children in school is not likely to be noted through 
 the multiple GP systems related to the children - but through a 
 Community system (of whatever sort) - and then messaged back to the 
 EHR as seen by the GP - so there's clearly an other place.  
 Similarly Social history information may well arrive from the Social 
 services system ... 

ah well - I guess I was talking in the idea future world of EHRs being 
everywhere, not today. In the future of a shared care, community-based 
EHR I would expect both types of carers you mention to be entering the 
data into the EHR, not in some other system... maybe I am wrong here.

Anyway, I accept what you say - let's just say that now and in the 
future, in many instances, the data for the transaction types i mention 
will come from GPs and other carers accessing and modifying the EHR.

 instead come through the application / EHR kernel API,
 fine, so long as this means:
 through *an* application *and/or* the kernel API 

yes - whatever application being used.

 and create EHR data on the fly.
 fine, so long as this means, for example:
 receive (and store) message data,
 acknowledge message data if appropriate according to implementation 
 requirements,
 assign message data to EHR as agreed by all users of EHR *or*
 reject message data for EHR as agreed by all users of EHR (but in this 
 case log receipt of message data even if not available for 'default 
 display'). 

well I wasn't talking about messages here - I was talking about 
communication through a network-visible API, which is what you get with 
.net, SOAP, Corba etc.

 This should have read Sorry if I have missed *something*.  I guess 
 from mails on another thread that these issues will get another airing 
 in Baltimore.  What it underlines for me is the need for precision in 
 our use of terms - and I plead guilt to imprecision when doing/saying 
 things in haste, and sometimes at other times too :).

me too;-)


- thomas beale



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Archetype ontology -- on the horizon a huge extra payload ?

2002-09-15 Thread Jean Roberts
If health and social care continue to converge as is happening in the UK
then the protocol of Soc Services is to also record things that may have
been considered appropriate in principle but which the individual
professional based on knowledge of the individual client circumstances
chose explicitly NOT to do. This and the current discussion about
'signing' could have major ramifications on size and performance of
records management systems. Any comments?
Jean Roberts

 st dguest at zeeclor.mine.nu writes
On Sat, 2002-09-14 at 21:03, Gerard Freriks wrote:
 Karsten,
 And others,
 
 
 What is your idea?
 
 - Can you agree with me that it is possible to proof that information was in
 a database at a certain time in most systems?
Certainly. That's what Horst's gnotary is about. 
http://www.gnumed.net/gnotary/

 But most systems are unable to proof what was seen on a screen and signed
 before being committed to the record or sent to an other entity?
 - What are the consequences of the extreme but defendable position of
 TNO-PG?

Gerard 

The logs would show that all the relevant patient data had been
downloaded to the client. I think it is asking too much of the process
to also verify that the doctor saw it on the screen, was in a fit state
to process the data and come to a logical conclusion. 

In my experience only the clinical note written on the day can concisely
log what data was processed to come to the clinical management plan.
Having pointers to the relevant data is helpful (e.g. see last entry 5
July 2002; Dr Jones' letter, 26 February 2000, histopathology skin 14
September 2002). I once thought a drag and drop hyperlink might be the
best way to do this but text entry is as efficient; just not as cool. 

Is this what you are trying to achieve? 

David 



Phoenix Associates, 19 Church Meadow, Ipstones, Staffs, ST10 2LS  UK
email : jean at hcjean.demon.co.uk   http://www.hcjean.demon.co.uk
tel 07771 804472  or tel/fax+44 1538 266944
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Archetype ontology

2002-09-15 Thread Karsten Hilbert
1) How do I know that the passphrase I typed in to be used for
  the secret key is used to sign what I see on screen and
  nothing else ?

2) How does the court know that a signed screenshot was
   actually shown on screen and not just fabricated and never
   shown ? (It is my responsibility to _inspect_ what is being
   shown but I cannot prove that signed screenshots were
   actually displayed (on current-day systems).

This isn't about 100% proof, this is about level of trust,
feasability, deniability and due process. Even with signing
screenshots.

Or did I miss something ?

Since it is my responsiblity to carefully inspect the
on-screen information I could just as well extend that view to
that it is my responsibility to use a system that I can trust
to show me what is actually in the database. Thusly I could
just as well sign database content. Gerard himself remarked
that we cannot sign that anyone actually reviewed any
information, only that it was made available. The latter can
be at the level of a screenshot - or at the level of database
content. After all it is my responsibility to inform myself
no matter where I get the information from. Say, I am using an
SQL shell and sign screenshots of my queries. Does this mean I
am not liable for the anaphylactic reaction just because I
didn't do the query for the known penicillin allergy ?!?
Obviously not, although I understand your position to be: It
hasn't been shown to me hence I am not to blame. What other
purpose might a signed screenshot server ? To shift blame to
the EHR software manufacturer ? 

Lastly, one simple question. How does TNO propose to handle
the audit trail of signed screenshots simply in terms of
storage requirements ?

 Making a hash of a screen dump indicates: This is the information as I saw
 it on a screen and take responsibility for it by signing.
Nah, I doubt you really believe in the coherency of this
statement. A screendump merely shows what a screen _may_ have
looked like.

Karsten Hilbert
-- 
GPG key ID E4071346 @ wwwkeys.pgp.net
E167 67FD A291 2BEA 73BD  4537 78B9 A9F9 E407 1346
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Archetype ontology

2002-09-15 Thread Gerard Freriks
On 15-09-2002 11:26, Karsten Hilbert Karsten.Hilbert at gmx.net wrote:

 1) How do I know that the passphrase I typed in to be used for
 the secret key is used to sign what I see on screen and
 nothing else ?


Because a special secure device does all the encrypting.
After having inserted the Health professional Card


 
 2) How does the court know that a signed screenshot was
  actually shown on screen and not just fabricated and never
  shown ? (It is my responsibility to _inspect_ what is being
  shown but I cannot prove that signed screenshots were
  actually displayed (on current-day systems).


Because the secure device is able to place the information on the screen.

Having a screenshot provides a richer picture than a set of bits and bytes
down deep in the database.


 
 This isn't about 100% proof, this is about level of trust,
 feasability, deniability and due process. Even with signing
 screenshots.
 

True.
I'll have more confidence in a message displayed on a screen than bits and
bytes in a distributed database in an Health Information Infrastructure


 Or did I miss something ?
 
 Since it is my responsiblity to carefully inspect the
 on-screen information I could just as well extend that view to
 that it is my responsibility to use a system that I can trust
 to show me what is actually in the database. Thusly I could
 just as well sign database content. Gerard himself remarked
 that we cannot sign that anyone actually reviewed any
 information, only that it was made available. The latter can
 be at the level of a screenshot - or at the level of database
 content. After all it is my responsibility to inform myself
 no matter where I get the information from. Say, I am using an
 SQL shell and sign screenshots of my queries. Does this mean I
 am not liable for the anaphylactic reaction just because I
 didn't do the query for the known penicillin allergy ?!?
 Obviously not, although I understand your position to be: It
 hasn't been shown to me hence I am not to blame. What other
 purpose might a signed screenshot server ? To shift blame to
 the EHR software manufacturer ?


The whole thing has to do with liability and legal proof.

If next to the information in a database the style sheet used to display is
stored, it is possibly good enough for legal proofs.
 
 Lastly, one simple question. How does TNO propose to handle
 the audit trail of signed screenshots simply in terms of
 storage requirements ?
 

This is a simple problem.
Now every year one hospital needs 1 kilometre of shelf space.

Have you ever compressed XML documents?
Have you ever looked at diskspace and prices?


 Making a hash of a screen dump indicates: This is the information as I saw
 it on a screen and take responsibility for it by signing.
 Nah, I doubt you really believe in the coherency of this
 statement. A screendump merely shows what a screen _may_ have
 looked like.
 

I think it is fully coherent.

Yes. But systems that have been certified will have a perfect screendump.
This is something that can be tested easily.

To proof that in a distributed environment all informationsystems worked
100% is much more difficult?
Right? Or wrong?

Gerard



 Karsten Hilbert

--  private --
Gerard Freriks, arts
Huigsloterdijk 378
2158 LR Buitenkaag
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Archetype ontology

2002-09-14 Thread Peter Schloeffel
Gerard,

Hopefully these TNO Essential EHR Requirements will be compatible with the ISO
13808 Requirements for an EHR Reference Architecture.  The draft 18308
Technical Specification will go for ballot in November so it would be very
important that we have the TNO requirements congruent with 18308 before then.  I
latest draft of 18308 was circulated to TC 215 WG1 on Friday and should be
available on the WG1 website within a few days but I will send you a copy
directly via separate email.

Peter Schloeffel
ISO 18308 EHR Requirements project leader

 -Original Message-
From:   owner-openehr-techni...@openehr.org
[mailto:owner-openehr-technical at openehr.org]  On Behalf Of Gerard Freriks
Sent:   Saturday, 14 September 2002 6:23 PM
To: Karsten Hilbert
Cc: Melvin Reynolds; Thomas Beale; William Hammond; Sam Heard;
Openehr-Technical; Ross Anderson
Subject:Re: Archetype ontology

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

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Archetype ontology

2002-09-13 Thread Thomas Beale


Melvin Reynolds wrote:

 Thomas,

 Somewhat to my surprise I find myself agreeing with most of your 
 points in the discussion below. 

he he he, that's the kind of reply I like to see;-)

 However, the final statement ... As soon as one starts thinking 
 about what has to happen to turn messages into EHR content, it 
 becomes clearer and clearer that the EHR is nothing like a compendium 
 of messages; for from it - it is a time-based accumulator of EHR 
 information, some of which is sourced from messages, much of which is 
 created by human users of GUI applications. seems like a gross 
 oversimplification of the reality.

 It is true a readable EHR is not likely to a compendium of messages. 
 But an EHR for use in a primary care context is not likely require to 
 present the same information (in full) as an acute secondary care EHR; 
 and neither are likely to require to present the full audit trail of 
 all messages, requests and reports that would be required of a 
 medico-legally complete (but clinically unhelpful) EHR. 

Well, that's probably fair enough (although I am not sure I believe that 
GPs are any less required to have medico-legal protection than any other 
clinician), but consider that even in a local GP EHR, modifications to 
things like Current Medications, Family history, Social History, 
Vaccination record, Therapeutic precautions , Problem list, will 
generally not come from messages - there is no other place for this data 
to come from but the GP application. It will instead come through the 
application / EHR kernel API, and create EHR data on the fly.

Now... try to imagine how useful the GP EHR would be minus the items I 
mention

 As well as a clarification of scope, it would seem to be important to 
 clarify at what level of context/granularity we are seeking to produce 
 the EHR. 

do you want to expand on this?

 Sorry if I've missed anything  - but the recent discussions would seem 
 to indicate that I'm not alone if I have. 

just point it out, and I'll try to explain more what I think, if at 
least that can help...


- thomas



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Archetype ontology

2002-09-13 Thread Gerard Freriks
On 13-09-2002 16:51, Melvin Reynolds MelvinR at AMS-Consulting.co.uk wrote:

 
 However, the final statement ... As soon as one starts thinking
 about what has to happen to turn messages into EHR content, it
 becomes clearer and clearer that the EHR is nothing like a compendium
 of messages; for from it - it is a time-based accumulator of EHR
 information, some of which is sourced from messages, much of which is
 created by human users of GUI applications. seems like a gross
 oversimplification of the reality.
 
 It is true a readable EHR is not likely to a compendium of
 messages.  But an EHR for use in a primary care context is not likely
 require to  present the same information (in full) as an acute
 secondary care EHR;  and neither are likely to require to present the
 full audit trail of  all messages, requests and reports that would be
 required of a  medico-legally complete (but clinically unhelpful) EHR.


The information a healthcare provider submits to the record is what he/she
sees on the screen. This committed information has to be signed. It is not
sufficient that the author is recorded but for legal proof it is necessaryb
that he/she signes the text with his/her private key.

This is the position we (at TNO-PG) take after having studied the legal
literature (1500 pages of texts from EU Directives, Dutch laws, FDA
documents and ethics documents)

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.

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.

-- work --
Gerard Freriks
TNO-PG
Zernikedreef 9
2333CK Leiden
The Netherlands

+31 71 5181388
+31 654 792800

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Archetype ontology

2002-09-04 Thread Gerard Freriks
Sam,

Could the following be another example?

The Blood pressure.
The RR as an act, a measurement, a procedure.
And the RR as a set of values, the result of the act, the measurement
results, the result of a procedure.

The act is one thing, an intention.
The value as the result of the execution of the intention.

The intention can exist without a real value.

In ENV 13606 part 2 there are the possibilities to add modifiers
(attributes) to 'things' that can express concepts like these.

The question is:
Will we need a new Concept Information Model (archetype) to distinguish
between the two or is one attribute enough?

Gerard



On 03-09-2002 22:31, Sam Heard sam.heard at bigpond.com wrote:

 Dear all,
 
 I have been working hard to get an ontology of archetypes developed that
 will show the health domain mapped into the openEHR architecture. I have
 found a couple of things:
 
 1. That there is often a link between an instruction and subsequent
 observations - which I think will be more important as knowledge bases are
 developed in the future. I have called the link an action specification and
 at present it is modelled as part of the instruction. Let me give a real
 example.
 
 If you prescribe a medicine then there are a number of attributes of that
 medication order - dose, form, route etc - and there is the frequency of
 administration. When you record that a medication has been administered -
 then you record the dose, form, route etc - but not the frequency. The link
 is the specification of the action - but not the conditional elements of the
 instruction.
 
 Many other things may be specified at the time that they are ordered and
 there may be protocols etc that are to be followed.
 
 For this reason - I have two new subclasses in the ontology (not in
 openEHR) - openEHR Observation - action and openEHR action
 specification. This allows me to say which action specification applies to
 an instruction and which obeservations it applies to.
 
 2. It might be necessary to state the sequence of different instructions.
 The French oncologists wish to state this for Surgery, Radiotherapy,
 Chemotherapy etc. Clearly each of these will have a complex action
 specification. How then to make it clear about the order of the
 instructions - should one finish before the other starts?
 
 I welcome your ideas. I have put the zipped (45K) protege files on
 www.gehr.org in the Watch this space section.
 
 Cheers, Sam
 
 Dr Sam Heard
 The Good Electronic Health Record
 Ocean Informatics, openEHR
 105 Rapid Creek Rd
 Rapid Creek NT 0810
 Ph: +61 417 838 808
 sam.heard at bigpond.com
 www.gehr.org
 www.openEHR.org
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