Jan 292013
 

Es gibt in den Vereinigten Staaten viele Organisationen und Behörden, die die Entwicklung und den Einsatz verschiedener Standards in dem Gesundheitsbereich fördern. In diesem Artikel findet sich eine kurze Zusammenfassung, die allerdings viele Details außer Acht lässt. Da Politik eine große Rolle spielt kann sich die Situation natürlich jederzeit ändern. Grundsätzlich ist das Gesundheitswesen ist in den USA gesetzlich geregelt und vom Bund und den Bundesstaaten finanziert.

Ich habe diesen Artikel zuerst auf Englisch geschrieben und erst danach übersetzt; vielen Dank an Gerry Beuchelt, der viele Verbesserungsvorschläge machte! Vielen Dank auch an Bob Yencha, der für die englische Version Verbesserungsvorschläge machte. Für etwaige Fehler bin ich natürlich zuständig.

Office of the National Coordinator for Health Information Technology (ONC; http://healthit.hhs.gov/): ONC ist ein Teil des US Bundesgesundheitsministeriums, dem Department for Health and Human Services (HHS). Es wurde 2004 gegründet. ONC soll die Nutzung geeigneter EDV-Standards im Gesundheitssystem unterstützen und fördern, und auch EDV-Produkte nach den Standards zertifizieren. Das ONC finanziert auch andere Aspekte der EDV im Gesundheitswesen wie zum Beispiel die 'Meaningful Use' Vorschriften.

Centers for Medicare and Medicaid Services (CMS; https://www.cms.gov/): Die CMS verwalteten verschiedene öffentliche Krankenversicherungen: Medicare (Krankenversicherung für ältere Leute sowie jüngere Leute mit Behinderungen), Medicaid (bedürftigkeitsgeprüfte Krankenversicherung) und das Children's Health Insurance Program (CHIP, Krankenversicherung für Kinder). Die CMS legen zwar keine Mindeststandards für EDV in der klinischen Betreuung fest, verlangen aber eine detaillierte Berichterstattung über die Einhaltung von Qualitätsnormen.

Meaningful Use (http://www.healthit.gov/policy-researchers-implementers/meaningful-use): Meaningful Use (MU) ist ein HHS Förderprogramm in der Gesundheitswesen-EDV, welches unter anderem die Nutzung von zertifizierten IT-Systemen für Patientenakten fördert, um die Qualität der Krankenpflege zu verbessern. Im Rahmen von MU werden auch die passenden EDV-Standards identifiziert, die von den Systemherstellern implementiert werden müssen. Für diese Funktion nimmt ONC eine leitende Stellung ein. Das gesamt MU Programm wird stufenweise über einige Jahre hinweg eingeführt. Stage 1 (Stufe 1) wird auch "2011 Edition" genannt und wurde vor zwei Jahren eingeführt. Die Anforderungen für Stage 2 (Stufe 2) wurden vor kurzem unter dem Titel "2014 Edition S&CC final rule" veröffentlicht. MU Stufe 2 ergänzt die "CMS Stage 2 Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs". Jenseits von 2014 gibt es konkrete Pläne für Stufe 3; weitere Stufen werden mit Hinsicht auf Politik und geschätztem Bedarf vorgenommen.

Health Level 7 International (HL7; http://www.hl7.org, http://www.hl7.de): HL7 ist eine ANSI-akkreditierte internationale Organisation, mit Mitglieder und Tochterorganisationen in vielen Ländern. HL7 erstellt EDV Standards für das Gesundheitswesen auf der Basis einer umfassenden Gesamtarchitektur. HL7 Standards können als 'normativ' oder 'informativ' eingestuft werden. Normative Standards untergehen eine Phase, die als 'Draft Standard for Trial Use' (DSTU) (Entwurf-Standard zur Probenutzung) bezeichnet wird, in der sie getestet werden können, bevor sie normative Standards werden. Es gibt eine Liste der DSTU-Standards unter http://www.hl7.org/dstucomments/. Die Liste der ANSI-anerkannte HL7 Standards ist hier zu finden: http://www.hl7.org/implement/standards/ansiapproved.cfm, und die Liste der ISO-anerkannten HL7 Standards ist hier: http://www.iso.org/iso/search.htm?qt=HL7&sort=rel&type=simple&published=on. Nicht-Mitglieder von HL7 müssen für Kopien der Standards bezahlen, aber HL7 hat angekündigt, die meisten Standards im Laufe des Jahres 2013 kostenlos zur Verfügung zu stellen. Die Meaningful Use Vorschriften beziehen sich sowohl in Stufe 1 als auch in Stufe 2 direkt auf eine Vielzahl von HL7 Standards.

Integrating the Healthcare Enterprise (IHE; http://www.ihe.net/, http://www.ihe-d.de): IHE ist ein Industriekonsortium in dem Profile verschiedener EDV-Standards erstellt werden, damit der kompatible Austausch von Gesundheitsdaten optimiert wird. IHE ist ebenfalls eine internationale Organisation mit vielen Mitgliedern, wobei viele IHE Mitglieder auch Mitglieder bei HL7 sind. Jedes Jahr veranstaltet IHE ein 'Connectathon', in dem EDV-Hersteller die Kompatibilität ihrer Produkte testen können. Auch die IHE-Profile und IHE Technical Frameworks (technische Rahmenwerke) werden in den Meaningful Use Vorschriften benutzt.

Dec 222012
 

There are a number of organizations in the US trying to encourage the use of various standards in healthcare, buttressed by US Federal funds. Here's a brief summary of some of them, which glosses over many details. All of this is subject to change at any time depending on both federal and state politics (in the US, some parts of the healthcare system are funded and managed federally, others at a state level). I wrote this for a friend in Germany, and then thought others might also find it useful.

Office of the National Coordinator for Health Information Technology (ONC; http://healthit.hhs.gov/): part of the US Department of Health and Human Services, the National Coordinator has the job of encouraging the adoption of healthcare IT and appropriate standards. It's a relatively new department, founded in 2004. It certifies health IT products according to the standards it adopts, and provides funding for various aspects of healthcare IT, for example as part of Meaningful Use.

Centers for Medicare and Medicaid Services (CMS; https://www.cms.gov/): runs Medicare (health insurance for the elderly as well as younger people with disabilities), Medicaid (means-tested health insurance for those on low incomes), and the Children's Health Insurance Program. CMS doesn't set the standards for the clinical care itself, but they do set standards for reporting the quality metrics for clinical care, as well as dealing with payment for their programs.

Meaningful Use (http://www.healthit.gov/policy-researchers-implementers/meaningful-use): the US version of Meaningful Use is a health IT program that's meant to promote the spread of electronic health records to improve health care in the United States. There are a number of aspects to this program. CMS provides financial incentives to physicians and other eligible professionals, as well as hospitals, to use certified electronic health record (EHR) systems, for example. The other part of the program is deciding which standards are the appropriate ones for the EHR systems to use. This is where ONC plays a role. The project is being rolled out in stages across a number of years. Stage 1 is also called the 2011 edition. Stage 2 was just released; the Stage 2 Meaningful Use set of standards is also known as the 2014 Edition S&CC final rule and complements the CMS Stage 2 of the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. There are concrete plans up to Stage 3; any further stages depend on politics and perceived needs.

Health Level 7 International (HL7; http://www.hl7.org): an ANSI-accredited standards developing organization that has members and affiliates in many countries. HL7 creates healthcare IT standards based on an overall architecture. Standards can be normative or information, and go through a period of trial use (Draft Standard for Trial Use; DSTU) before becoming full standards. The list of standards in the DSTU phase is at http://www.hl7.org/dstucomments/. The list of ANSI-approved HL7 standards is at http://www.hl7.org/implement/standards/ansiapproved.cfm, and the list of ISO-approved HL7 standards is at http://www.iso.org/iso/search.htm?qt=HL7&sort=rel&type=simple&published=on. People who are not members of HL7 do have to pay for the standards, but HL7 has committed to making them free of charge in early 2013. Several HL7 standards are quoted in the meaningful use regulations that have been published so far, both Stage 1 and Stage 2.

Integrating the Healthcare Enterprise (IHE; http://www.ihe.net/) is an initiative to create profiles of various standards to improve the way healthcare IT systems share information. They are an international organization with many members and run connectathons to test interoperability of healthcare IT systems both in the US and in Europe. Many IHE profiles and technical frameworks are cited for Meaningful Use. There is significant cross-membership between HL7 and IHE.

Thanks to Bob Yencha for review and suggestions for improvements. Any errors, of course, are mine. After writing this, I do find myself wondering whether there is some rule about three-letter acronyms in healthcare IT. And no, there is no meaning to the ordering of the descriptions.

Sep 072007
 

O’Reilly is pub­lish­ing a series of art­icles this month, all writ­ten by vari­ous women work­ing in tech­no­logy. For some reas­on they asked me to take part; I no idea what the cri­ter­ia were. In fact I care­fully didn’t ask who else was invited, so I’ll be as sur­prised as the rest of you to see whose art­icles are pub­lished. So far the authors have been Leslie Hawthorn, Maria Klawe, Nelly Yusupova, Shel­ley Powers, and Dru Lav­igne. Any­way, they pub­lished mine today at Work­ing for Stand­ards. Hope you enjoy it!

Jul 122007
 

Rick Jel­lif­fe, who’s been in the middle of lots of stand­ards efforts, writes on the sub­ject at Is our idea of “Open Stand­ards” good enough? Veri­fi­able vendor-neutrality. Worth read­ing, although he does make the assump­tion that the term “open stand­ards” means “cre­ated by some stand­ards organ­iz­a­tion”. Although that’s a tempt­ing defin­i­tion, and the one used by a lot of people (and the one I hap­pen to prefer), it’s not the only defin­i­tion that I’ve seen. I’ve seen three main cat­egor­ies of defin­i­tions of the term “open stand­ard” when applied to some spe­cific­a­tion:

  • Any­one can read the spe­cific­a­tion (usu­ally without pay­ing); often applied to pro­pri­et­ary spe­cific­a­tions which are treated as de facto stand­ards.
  • Cre­ated in a stand­ards organ­iz­a­tion that allows any­one to take part who has rel­ev­ant expert­ise or can pay the appro­pri­ate dues.
  • Able to be used in any open source pro­jects (i.e., there are restric­tions on the types of licenses that can be used).

Recog­nising that lots of people use the term “open stand­ard” to mean dif­fer­ent things, the Liber­ty Alli­ance recently pub­lished what that term means in the con­text of Liber­ty Alli­ance spe­cific­a­tions and guidelines. It’s called the Liber­ty Alli­ance Com­mit­ment to Open Stand­ards and it’s a very brief doc­u­ment out­lining a set of con­di­tions for those spe­cific­a­tions and guidelines (yes, the doc­u­ment talks about tech­nic­al spe­cific­a­tions but really it applies to oth­er types of doc­u­ments as well). The top item in the list of con­di­tions to be an open stand­ard, to answer Rick’s main point that rather than talk­ing “open stand­ard­s” we need to be talk­ing as much of “verifiable vendor-neutrality”, is can­not be con­trolled by any single per­son or entity with any ves­ted interests.

I dis­agree with Rick when he says that only ISO is truly vendor-neutral since only nation­al bod­ies vote, as those nation­al bod­ies could in the­ory be swayed by vendors. What you really want is to bal­ance the needs of all parties (vendors, users, gov­ern­ments), but that’s dif­fi­cult to attain in any organ­iz­a­tion. You need not only an organ­iz­a­tion that is set up to allow for input from all those stake­hold­ers (to pro­duce stand­ards that are evolved and man­aged in a trans­par­ent pro­cess open to all inter­ested parties and approved through due pro­cess by rough con­sensus among par­ti­cipants) but you also need to have enough par­ti­cipants who are inter­ested in the end res­ult, and have the appro­pri­ate expert­ise. And you need a com­pet­ent chair for each com­mit­tee, of course.

Nov 282006
 

I have the good for­tune to work with Pat Pat­ter­son at Sun and one of the things we dis­cussed quite a lot shortly before I went on mater­nity leave was how to make it easi­er for people to use Liber­ty pro­to­cols for their iden­tity needs. One of the com­plaints I’ve heard is that there isn’t enough sample code in the world show­ing how to use and imple­ment SAML. Given that Sun’s Access Man­ager does imple­ment SAML, along with vari­ous oth­er Liber­ty Alli­ance stand­ards, it seemed like it should be pos­sible to put togeth­er some sample code that uses Access Man­ager. And, given that Access Man­ager is now open source as part of OpenSSO, it made sense to cre­ate another open source pro­ject. But, this pro­ject should use lan­guages oth­er than Java, to give the LAMP (or MARS) developers and imple­ment­ors some code that they can use, tweak, and fur­ther develop. And put back into the pro­ject of course <grin>. I came up with a bunch of use­less names, and Pat came up with Light­bulb (goes with LAMP). Then as I waddled off into mater­nity leave, Pat did the pro­gram­ming and came up with a way to imple­ment a SAML 2.0 ser­vice pro­vider in pure PHP, without even need­ing the OpenSSO or Access Man­ager code. 

Pat’s giv­ing a webin­ar on this tomor­row morn­ing Paci­fic time; you need to register for it first.

We’re hop­ing that oth­er people will con­trib­ute rel­ev­ant code, in any lan­guage, for people to use when they want to imple­ment or integ­rate SAML cap­ab­il­it­ies into their sys­tems, wheth­er they’re blog­ging sys­tems, wikis, or any­thing else where iden­tity man­age­ment is use­ful. The pro­ject is loc­ated here; it’s easy to join, add a sub-project, and com­mit some code. Or just browse and see what’s there and what’s use­ful. Have fun!

Oct 162006
 

We’re plan­ning on trav­el­ling to Aus­tralia for a vaca­tion, and since the baby will shortly need a new car seat any­way, I was hop­ing to get one that matches Cana­dian and Aus­trali­an stand­ards. Britax makes car seats in each coun­try but when I called them they said the Cana­dian car seats did not meet Aus­trali­an require­ments (hard to believe they can be all that dif­fer­ent, I assume she meant that the car seat isn’t cer­ti­fied in both coun­tries).

Does any­one know of a car seat that can be used for a big infant under the age of 1 (in Canada, that means rear-facing) in both coun­tries? Or have sug­ges­tions? When we’re in Aus­tralia we’ll mostly be with friends rather than driv­ing rent­als, hence the desire to take our own car seat.

This is one place where true inter­na­tion­al stand­ards would be help­ful… I won­der why every coun­try needs its own?