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ePrescription

March 18th, 2010

 

ePrescription is an important element in improving the quality of patient care and as such it is also part of requirements for CCHIT qualifications and MIPPA incentive payment.

 
The data interchange standards for ePrescriptions are maintained by NCPDP (National Council for Prescription Drug Programs) for the pharmacy services sector of the healthcare industry. 
 
There are few companies offering transmission networks for electronic connection between Physicians and Pharmacies nationwide.  They mostly use and enable communication between HL7 and NCPDP SCRIPT Standards.
 
 Among the leaders are SureScripts, RxHub and ProxyMed, with SureScripts currently dominating the market with about 90% market share.
 
Following is the list of Companies providing solutions or gateway for Prescription transmissions: 
 

 

 

 

 

General, Market, Technology, Vendors

Product Review: eClinicalWorks

December 2nd, 2009

 As part of my continuous EHR product review I recently evaluated AllScript, NextGen and eClinicalWorks. 

 
This post is covering eClinicalWorks. (See my previous post on NextGen)
 
To summarize among the three, I like eClinical the best. It is technically solid, and 
provides a fully integrated platform, including PM, EMR and Billing.
 
 
However I think the User Interfaces are not as intuitive as they could be. I hope
the product manager will put some effort in optimizing the user experience. 
That would motivate eClinical users in utilizing all the power under the hood. 
 
 
The system provides customizable templates per spatiality and provides a good 
Clinical Decision Support System (CDSS).
 
The company started with smaller physician groups before targeting hospitals 
and larger clinics. As such the product design is well suited for small offices.
 
In larger environments the community module allows patient records to 
be shared between physicians (e.g. referrals).
 
My favorite feature is eCliniForms, which allows to scan in or create office forms 
in the system (such as consent or hospital admission forms).
eCliniForms can be used to input data and integrate directly with patients’ chart.
 
Following you can see a demo of eCliniForms:
 

 
 
 
In terms of pricing eClinicalWorks has 3 offerings:
 
- Traditional client server (you purchase the software license outright and data lives on a server in your office).  The pricing is around $10,000 for the first physician, $5,000 for each subsequent provider. An annual support & maintenance license fee of 18% could apply, translating to about $200/month.
 
- Hosted model or ASP (monthly fee, data lives on a server at the vendor’s facility).  The pricing is around $500/month for the first provider, with discounts for subsequent providers.
 
- Lease or Subscription (monthly fee, data lives on your server in your office). $400/month for the first provider. It goes down around 10% per additional doc on the contract.
 
The above fees are for the combined EHR-PM product.  More details can be found on their website:
They charge an additional $250/month for billing and scheduling and $25/month for e-prescribing. Training is between $500 to $750 per day plus travel expenses at $250/day.
 
 
Here is a Flash Demo of the product:
 
 
They recently partnered with Sam Club to sell eClinical EMR, in a packaged deal along with Dell computers to cover both software and hardware. More info here: http://www.samsclub.com/health/
 
eClinicalWorks is opening an office in Pleasanton California before end of the year.
 
 

 

General, Market, Technology, Vendors

Product Review: NextGen

November 25th, 2009

Just recently I evaluated 3 EHR systems (AllScript, NextGen and eClinical) and will gradually dump my notes into individual reports for each one.

 
NextGen (by Quality Systems (NASDAQ:  QSII)) provides an all-in-one solution, including PM, EMR and Billing.
 
 
 
Among the three, NextGen has the best user interface. It is intuitive and easy to use. 
The visual aid helps physicians to point and click their way through an entire exam.
 
 
   
   
 
NextGen EMR is completely integrated system and supports different specialties. It has a large selection of pre-built templates to help automate the workflow.  
 
Having said that, the product philosophy is that you will like the pre-built templates as they are. Adjustments are possible but that is relatively hard and would require engineering support. 
 
For example on HPI screen symptoms are listed as check-boxes in comparison to decision-tree-style selection lists that are used by many other vendors.
 
This is presented by NextGen sales as a competitive differentiator that removes the restrictions of sequential questioning needed in decision-tree pick lists.
 
 
NextGen EMR integrates with NextMD, which is the company’s patient-provider portal that facilitates effective electronic interactions between the patient and the practice.
 
 
The NextGen product is written in Visual Basic and Visual C++ and uses MS SQL database and Active Domain.  This implies an open architecture for custom developed extensions, such as integration adaptors and complex reports. NextGen has its own integrated word processing for creating/customizing letters and communication materials. The company is currently working on optional interface with Microsoft office.
 

General, Market, Technology, Vendors ,

Product Review: PracticeFusion

November 8th, 2009
I have been recently exposed to PracticeFusion, a three years old player in EMR market. They offer a fully hosted (SaaS) PM and EMR system at no charge! (more about it below) 
 
The product is very easy to setup and use.  The user interface is self-explanatory and intuitive. Each top category of functionality has a short video tutorial that helps getting started.
 
Adding Patients, scheduling visits and dealing with charts is very simple. 
The only thing I didn’t like must was document handling, which is not as easy to work with, specially if you are dealing with lots of scanned materials. 
 
 
They have partnered with Digital Island to offer conversion of paper charts into electronic charts. 
 
As for billing, they offer own integrated billing system that charges about 6% of receipts that are received and deposited. Alternatively they offer secure email system for working with existing internal and external billers. I am not sure how well this will work!
 
 
The Web interface takes advantage of Flex 3, Adobe’s rich Internet application interface and the system backend is cloud-based and ensure scalability.
 
However as many other SaaS solutions there are few points to keep in mind:
 
Switching to another solution provider is going to be a nightmare. There is no easy way to get the data (which you own!) and move it to other hosted solution. 
So basically you are stuck with one SaaS provider as soon as you start.
 
Furthermore there is a question on what happens when Internet goes down; how would you access schedules and patients’ records during that time?
 
And finally, there is always challenge of integration in SaaS environment, in this case,
for example, integration with medical devices and instruments.
 
 
In terms of functionality E-Prescription is the most important missing piece, which seems to be a priority items on their roadmap. 
 
 
As for business model PracticeFusion plans to make money on free software by connecting advertisers with doctors while they are working on the system. Apparently they have already signed up advertisers such as Johnson & Johnson, AstraZeneca LP and Ortho-McNeil-Janssen Pharmaceuticals, Inc.
 
Given how difficult it is for a drug salesperson to get a doctor’s attention, the CEO, Ryan Howard, is convinced this business model will work.
 
For Physicians who don’t like to see ADs on their screen, an AD-free version of the solution is available at $100/month/provider.
 
For more info here is an interview with Ryan: 
 
 
In August 2009 Practice Fusion received an investment from SaleForce.com 
The investment is reportedly between $5 to $10 million. 
As a side note, to me this was an excellent strategic move by SalesForce, which is heavily focused in promoting its cloud platform.

 

 

General, Market, Technology, Vendors ,

The EMR war is still going on ..

November 2nd, 2009

 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.
 
 

General, Market, Technology, Vendors ,

Clinical Document Architecture (CDA) explained

October 28th, 2009

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:

 

General, Technology ,

What does HL7 enablement means?

October 23rd, 2009
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.
 

General, Technology , , ,

HIPAA and 21CFR11 overlaps

October 12th, 2009

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.
 
 

General, Technology , ,

Hybrid system for consent form and other signed records

October 9th, 2009
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 ,

What is CCHIT certification that everybody is talking about?

October 2nd, 2009

The Certification Commission for Health Information Technology (CCHIT) is a nonprofit organization with the public mission of accelerating the adoption of health IT.

Founded in 2004, the organization is certifying electronic health records (EHR) systems since 2006.

CCHIT has numerous certification programs, some developed under contract with HHS/ONC and others developed in response to requests from stakeholders throughout the industry.

The EHR certification criteria were developed through a voluntary, consensus-based process engaging diverse stakeholders, and the Certification Commission was officially recognized by the Federal government as a certifying body.

As of mid 2009 about 200 EHR products have been certified, representing over 75% of the marketplace.

The Certification Commission for Health Information Technology is a nonprofit organization with the public mission of accelerating the adoption of health IT.

Founded in 2004, the organization is certifying electronic health records (EHR) systems since 2006.

CCHIT has numerous certification programs, some developed under contract with HHS/ONC and others developed in response to requests from stakeholders throughout the industry.

The EHR certification criteria were developed through a voluntary, consensus-based process engaging diverse stakeholders, and the Certification Commission was officially recognized by the Federal government as a certifying body.

As of mid 2009 about 200 EHR products have been certified, representing over 75% of the marketplace.

CCHIT inspects every product in three areas:

Functionality-the ability to create and manage electronic records for all of a physician practice’s patients, as well as automate the flow of work in the office.

Interoperability-the ability to receive and send electronic data between an EHR and outside sources of information such as labs, pharmacies, and other EHRs in physician offices and hospitals.

Security-the ability to keep patient information safe and private.

Functionality

Simply stated, for 08 CCHIT requires ambulatory EHR products to provide every function that a physician needs today to manage every patient’s care efficiently, safely, and with high quality, electronically — instead of on paper.

There are approximately 350 functionality criteria. The broad areas covered are:

Organizing patient data – demographics, clinical documentation and notes, medical history

Compiling lists – problems, medication, allergies, adverse reactions

Receiving and displaying information – test results, consents, authorizations, clinical documents from outside the practice

Creating orders – ordering medication or diagnostic tests; managing order sets, orders, referrals; generating and recording patient-specific instructions

Supporting decisions – presenting alerts and reminders for disease management, preventive services, wellness; checking for drug interactions and guiding appropriate responses; supporting standard care plans, guidelines and protocols; updating decision support guidelines

Authorized sharing – managing practitioner/patient relations, enforcing confidentiality, enabling concurrent use among multiple practitioners and healthcare personnel

Managing workflow – assigning and routing clinical tasks, managing the taking of medication and immunizations, communicating with a pharmacy

Administrative and billing support – using rules to assist with financial and administrative coding; verifying eligibility and determining insurance coverage

While there are several dozen new Functionality criteria proposed for addition for 09 (beginning July 1, 2009), many are simply clarifications and refinements of existing criteria. There is no justification for delaying investment in EHRs for want of functionality in certified products.

Interoperability

In the Interoperability domain, for 08 certification CCHIT requires ambulatory EHR products to use approved standards to send and receive all forms or clinical data that are practical to exchange today, as well as demonstrate ability to support emerging areas of data exchange.

There are approximately two dozen Interoperability criteria. The broad areas required are:

Laboratory results – comply 100% with federally-approved standards to receive and store lab results, differentiate between a preliminary and final result, process corrected results, and include information on test accuracy. A basic capability to view x-ray images is also required.

Electronic prescribing – comply 100% with federally-approved standards to send a new prescription, approve a refill, check that a medication is on the approved formulary, check patient eligibility, and obtain medication history from the pharmacy.

Exchange summary documents – demonstrate first-stage compliance with federally-approved standards to receive and display a patient summary from an outside system, and send a patient summary to an external system.

Although the standards for exchanging summary documents have been federally-approved, the Health Information Exchanges (HIE) that will actually route these messages between providers are only available in a few areas of the country. Thus, this is considered an emerging area, and CCHIT’s requirements are designed to ensure that EHRs keep up to date as these capabilities are developed. For 09, second-stage compliance will be required, demonstrating that the EHR can use “XDS” transactions, plus support either of two standard approaches for coordinating patient identification between the EHR and another system.

It would be extremely unwise to delay health IT investment in hopes of waiting for Interoperability to perfected first. The lab results, electronic prescriptions, and summary documents that can be exchanged now represent the most important clinical transactions, and they can help increase quality and safety while reducing waste and errors. Without EHRs in place, the impetus to develop Interoperability would be drastically reduced, and the only result could be a permanent standoff in the development of both.

Security

Simply stated, for 08 CCHIT requires ambulatory EHR products to provide state-of-the-art technical capabilities needed to keep patient information safe and secure.

There are approximately 50 Security criteria. To be certified, an EHR must meet 100% of them. The broad areas covered are:

Authentication of users (proving identity)

Controlling access based on the user role or the context of a care situation.

Auditing every access and use of records

Encryption of any data sent out of the system.

Protection against viruses and other malware

Backup of data to prevent loss in case of computer failure or disaster

Security is another area, like Functionality, that is considered mature. Updates for 09 are minimal and there is no justification for delaying health IT investment to wait for additional criteria.

Summary

All of CCHIT’s work is done with full transparency and broad public input. We are pleased to respond to all requests from policymakers for information.

With trusted health IT certification already fully operational, healthcare policymakers need not be concerned with the details of how to qualify health IT products and can focus instead on designing policies and incentives to encourage adoption, bringing the benefits of a 21st century healthcare system to all Americans.

Source: http://www.cchit.org

Technology