EHR to Bridge the Two Parallel Worlds

November 6th, 2009
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These days I am spending some time on Process Improvements at Life Sciences and Pharma Companies. While doing so I noticed how much the Healthcare reform is going to help Life Sciences industry, indirectly.

 
Historically Life Sciences and Healthcare industry have been two strange and detached worlds.
But EHR related activities and standardizations, such as HL7, are creating more and more touch points for bringing these two parallel worlds together. 
 
The interoperability between EMR and CTM systems, and resulting interactions between Site Investigator and Primary Physician during Clinical Study are some of the obvious benefits.
 
On the technical side, I see CDA and CDISC to gradually converge on data structure, while utilizing XSLT for transformation at the end points to integrate clinical research data and health care data.
 
 

 

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The EMR war is still going on ..

November 2nd, 2009
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 The EMR war is going on and will intensify in the coming years. Vendors are becoming more and more aggressive and innovative to gain and keep their market share in the rapidly growing EHR market. This competition will ultimately benefit EMR users with better products in the long run. But in the short term it will eventually make the buying decisions harder.

 
Among recent products updates is one from Praxis.
Praxis just announced a new EMR system that learns from the physician using it.
According to the company EMR templates reduce Physicians freedom of expression, as they are nothing more than a boilerplate developed by a third party or expert for inputting clinical data. The inflexibility of templates causes a series of problems during everyday use.
 
Praxis upcoming version 5 is using Neural Networks to overcome this inflexibility by letting the software adopt to Physician instead of expecting the other way around. 
 
Being fanatic about Artificial Neural Networks (ANN) I would like to see them succeed! 
If you are interested in learning more about Artificial Neural Networks read on my other site.
 
 

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NextGen revenue increased by 22%

October 30th, 2009
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Quality Systems, the company behind NextGen product, just announced a 13% jump in profit and 22% increase in revenue.

 
The announcement said sales have recovered as health care providers have become more comfortable with the details of the American Recovery and Reinvestment Act of 2009, the federal government’s stimulus plan passed by Congress earlier this year.
 
As Steven Plochocki (CEO) put it:  "there seems to be a heightened comfort level in purchasing decisions relating to electronic health records systems.
 

General, Market, Vendors

Clinical Document Architecture (CDA) explained

October 28th, 2009
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Clinical Document Architecture (CDA) is an XML-based standard used for clinical document exchange within Health Level Seven framework. 

 
CDA has three levels of document definition, distinguished by the degree of granularity of the markup. Level One providing the least structure and Levels Two and Three providing increasing granularity.
 
Level One consists of Header, Body and HL7 Datatypes
 
Level Two includes Domain specializations 
 
Level Three includes full document semantics aimed to meet the machine processing requirement
 
 
HL7 Datatypes are defined for:
 
- Character strings and display data
- Codes and identifiers 
- Quantities
 
And Coded CDA components or elements are based on (SNOMED) and have the two-letter ending "cd". 
 

Here is an sample CDA level three:

 

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What does HL7 enablement means?

October 23rd, 2009
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HL7 is about moving data, in form of messages, between software systems within clinical environment. In other words it is a messaging standard that enables clinical/medical applications to exchange data. 
 
Information sent using the HL7 is packaged as a collection of one or more messages, each of which transmits one record or item of health-related information. Examples include patient information, patient visit data. laboratory record and billing information.
 
HL7 standard specifies both exchange mechanism as well as message format and data structure.
 
The HL7 transport mechanism relies on an Event-Driven protocol, typically based on MLP or MLLP (Minimal Lower Layer Protocol) over a TCP/IP socket connection. (See Apache Camel project for an open source implementation of MLLP protocol)
 
MLLP act as a wrapper around HL7 messages to introduce a notion of atomicity over TCP/IP (which is a "stream-oriented" connection).
 
The HL7 requires every application that accepts a message to send an Acknowledgment message back to the sending application. The sending application is expected to keep on sending a message until it has received an Acknowledgment message (referred to as ACK).
An acknowledgment message consists of two parts:
1) An MSH segment, which contains information about the sending and receiving applications and a MessageID
2) An MSA segment, which indicates whether the message was accepted or rejected
The acknowledgment message should not be sent until the data in the HL7 message has been read and consumed.
 
 
The protocol relies on "open system architecture", meaning that anybody can interface with the system using appropriate protocols, independent of the vendor
 
 
Each HL7 message is made up one or more segments, which are the building blocks of HL7 messages. And each segment consists of one or more Fields.
Segments group related information together, for example the PID segment contains information patient information such as ID numbers, name, address and date of birth.
 
In the following HL7 example message, you can see that each HL7 segment is located on it’s own line.
 
Example: (MSH, PID, OBR, OBX)
 
MSH|^~\&|GHH LAB|ELAB-3|GHH OE|BLDG4|200202150930||ORU^R01|CNTRL-3456|P|2.4
PID|||555-44-4444||EVERYWOMAN^EVE^E^^^^L|JONES|19620320|F|||153 FERNWOOD DR.^^STATESVILLE^OH^35292||(206)3345232|(206)752-121||||AC555444444||67-A4335^OH^20030520
OBR|1|845439^GHH OE|1045813^GHH LAB|15545^GLUCOSE|||200202150730|||||||||555-55-5555^PRIMARY^PATRICIA P^^^^MD^^|||||||||F||||||444-44-4444^HIPPOCRATES^HOWARD H^^^^MD
OBX|1|SN|1554-5^GLUCOSE^POST 12H CFST:MCNC:PT:SER/PLAS:QN||^182|mg/dl|70_105|H|||F
 
 
The latest release of HL7 (V3) mandates both Human and machine-readable data structure. As such the documents are structured in a format referred to CDA, or "Clinical Document Architecture", based on XML.  (See my other articles on CDA topic)
 
CDA documents are not birth-to-death aggregate records, but a means for packaging information for transmission. They can include text, images, sounds and other multimedia content.
 
CDA documents are typically a MIME encoded payload within an HL7 message.
 

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$210 per compromised medical record

October 20th, 2009
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 I was surprised to see the average cost of a data breach exceeded $210 per compromised record, creating an opportunity for computer crime rings to traffic in stolen medical records, according to a study sponsored by LogLogic.

 
The study shows patients may be surrendering their privacy as the $2.5 trillion medical industry pushes to accelerate the pace of digitizing health information records, prompted by federal stimulus funding.
 
 
According to the report the new HIPAA rules will help improving 
the protection of medial records. (see my post on new HIPAA rules)
 

 

General, Market ,

Cerner partners with CDW on EMR

October 19th, 2009
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Cerner  just announced a partnership with CDW Healthcare to beginning Nov. 1 offer "one-stop" purchase of it’s ambulatory e-health record systems, along with hardware, technical assistance, and deployment services to small and mid-sized doctor offices.  This is the first time Kansas City, Mo.-based Cerner has agreed to offer its complete suite of ambulatory solutions through a national channel partner, according to InformationWeek.

 
This seems to be a strategy move in view of the rising demand and I expect other EMR vendors to pursue similar distribution models to accelerate market penetration.
 

General, Vendors

HIPAA and 21CFR11 overlaps

October 12th, 2009
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Both HIPAA and 21 CFR Part 11 are concern with safeguarding Data. While 21CFR11 applies to Life Sciences Organizations (LSO), HIPAA applies to Healthcare Providers (HCP) and other "covered entities", such as insurance companies.

 
21 CFR Part 11 sets out the procedural and system requirements for controlling and auditing electronic records and signatures. It requires employing procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records.
 
Similarly HIPAA security rules are described as followed:
 
Physical Safeguards
Facility access controls
Work station use
Work station security
Device & Media controls
 
Technical Safeguards
Access control
Audit control
Integrity controls
Person or entity authentication
Transmission security
 
Administrative Safeguards
Security and access management
Secure incident handling
and implement policies and procedures to prevent, detect, contain and
correct security violations.
 
 
There are obvious requirement overlaps around
 
- Operational policies and SOPs 
- System and Record Access Control
- Audit trail
- Record keeping and retention
 
It just makes sense to start consolidating these requirements into one set. 
This has to happen sooner or later as we start sharing standardized medical records between healthcare providers and Pharmaceutical companies for Clinical Trials or Adverse Events reporting.
 
 

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Hybrid system for consent form and other signed records

October 9th, 2009
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Officially Part11 does not require that electronic records be signed using electronic signatures.
So electronic records may be signed with handwritten signatures that are applied to electronic records or handwritten signatures that are applied to a piece of paper that is link to the record.
The FDA is planned to publish guidance on how to achieve this link in the future, but for now it is suggested that you include in the paper as much information as possible to accurately identify the unique electronic record. As minimum that should include file name, byte size, creation date and a hash or checksum value such as
CRC (Cyclic Redundancy CheckOfficially Part11 does not require that electronic records be signed using electronic signatures.
So electronic records may be signed with handwritten signatures that are applied to electronic records or handwritten signatures that are applied to a piece of paper that is link to the record.
The FDA is planned to publish guidance on how to achieve this link in the future, but for now it is suggested that you include in the paper as much information as possible to accurately identify the unique electronic record. As minimum that should include file name, byte size, creation date and a hash or checksum value such as
CRC (Cyclic Redundancy Check).
Part11 does not require that electronic records be signed using electronic signatures.
So electronic records may be signed with handwritten signatures that are applied to electronic records or handwritten signatures that are applied to a piece of paper that is link to the record (referred to as hybrid).
The FDA is planned to publish guidance on how to achieve this link in the future, but for now it is suggested that you include in the paper as much information as possible to accurately identify the unique electronic record. As minimum that should include file name, byte size, creation date and a hash or checksum value such as CRC (Cyclic Redundancy Check).

Technology ,

Wells Fargo Initiates Coverage on Allscripts-Misys

October 5th, 2009
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According to Wells analyst AllScripts (MDRX) has a growth potential of 30% yr/yr over the next 5 years. That would translate to a stock valuation of $25-26 per share.

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