The purpose of this regulation is to set up the apparatus to certify and test EHR and EHR modules for meaningful use.  Initially, organizations will be certified by ONC to be temporary certifiers and testers (ONC-ATCB).  They will be responsible to both certify and test EHR and EHR modules.  The intent is to have ONC-ATCB up and running by the fall in order to have EHRs ready by 2011 and focus on Stage 1 Meaningful Use.  (N.B.  The public has 30 days to comment on this regulation).

ONC then intends to establish permanent organizations.  ONC will certify organizations to accredit certifying organizations.  The accrediting organizations are known as ONC-AA and the certifying organizations are know as ONC-ACB.  ONC-ACB will only certify EHR and Modules not test them.  Testing will done by separate organizations.  (Testing refers to actually demonstrating compliance while certifying includes reviewing test results.) The testing organizations will be accredited through the NIST NVLAP program.  ONC-ACB also will have surveillance responsibility and focus on Stage 2 and 3 of meaningful use.  Comment on this portion of the proposal is 60 days.

Criteria for certification has not been set up (mainly because meaningful use is being finalized) and ONC is asking for public comment.  Generally speaking, ONC-ATCB and ONC-ACB will conform with ISO/IEC Guide 65:1996 and ISO/IEC 17025:2005 (ISO 17025). ONC-AA would conform  to ISO/IEC 17011:2004. 

The idea of minimum standards also was discussed and ONC requested comment.  Meaningful Use will have minimum standards.  ONC will have to determine at what point an upward deviation from that standard constitutes a new requirement for certification.  Also, the idea of certifying modules also was discussed and required comment.  ONC realizes that some EHR modules will not have to meet every meaningful use standard and should not be required to be certified if not relevant.

Two final points:  I was glad that ONC is having the private sector taking responsibility for certification.  This decision allows for more ”on the ground” feedback.  Second, in the regulatory impact section an interesting point was made.  ONC believes that total EHR systems will be provided by a handful of vendors while start-ups will hand modules.

I will use this post to quote the recommendations that the FCC makes to expand healthcare through broadband. 

Create Appropriate Incentives for Health IT Utilization

1. Congress and the Secretary of HHS should consider developing a strategy that documents the proven value of e-care technologies, proposed reimbursement reforms that incent their meaningful use and charts a path for their widespread adoption.
   1. HHS should identify e-care applications whose use could be immediately incented through outcomes-based reimbursement.
   2. When testing new payment models, HHS should explicitly include e-care applications and evaluate their impact on the models.  Where proven and scalable, these alternative payment models would provide an additional solution for incenting e-care.
   3. For nascent e-care applications, HHD should support further pilots and tsting that review their suitability for reimbursement.
   4. As outcomes-based payment reform is developed, CMS should seek to proactively reimburse for e-care technologies under current payment models.

Modernize Regulation to Enable Health IT Adoption

1. Congress, states and the Centers for Medicare and Medicaid (CMS) should consider reducing regulatory barriers that inhibit adoption of health IT solutions.
2. The FCC and the Food and Drug Administration (FDA) should clarify regulatory requirements and the approval process for converged communications and health care devices.

Unlocking the Value of Data

1. The Office of National Coordinator (ONC) should establish common standards and protocols for sharing administrative, research and clinical data, and provide incentives for their use.
2. Congress should consider providing consumers access to-and control over-all their digital healthcare data in machine-readable formats in a timely manner and at a reasonable cost.

Many of the components such as quality improvements are to what we have found in the Stimulus and the Healthcare Reform.  I highly recommend that anyone interested in the Health IT field read at least the health section of the report.

In the current legislation, there was plenty of discussion about concepts which Health IT can enhance such as quality and performance, reporting and data collection.  Specifically, in HR 4872, there was a call for Medical Home pilots (Section 1302) and the creation of a Telehealth Advisory Board (Sec 1302).  For actual Health IT, the HR 4872, asked for a study by HHS in 2 years to determine how insurers were encouraging meaningful use as well as the promotion electronic health records (Sec 157).  The reconciliation bill also called for healthcare administrative actions to be done electronically.  The electronic process would utilize x12 standards.  A plan for implementation must be developed in 6 months with implementation in 2 years (Sec 1173A).

In HR 3590, Centers for Medicare and Medicaid must have a plan in 9 months to upgrade data and computer systems (10330).  The bill also calls for a physician quality comparison website called Compare (10331).

Second, I realize I had wanted to continue my 45 CFR 170: EHR Certification.  However, there were 2 recent developments that came up.  The FCC presented its broadband plan and facilitating health IT and telemedicine is one of its goals. (http://www.broadband.gov/).  Also, as I write Congress is debating healthcare reform.  While the point of this blog is not healthcare reform per se, should the bill pass, I will evaluate healthcare reforms impact on Health IT.

So over the next few weeks, I will be discussing: 45 CFR 170, the Broadband Plan and possibly the healthcare reform bill.

In this post, I will discuss the temporary certification process.  The core of this process lies with ONC, whicu will certify the organizations to temporarily test and certify EHRs.  These organizations would be known as ONC-Authorized Testing and Certification Bodies (ONC-ATCB).  To become an ONC-ATCB, an organization through its apllication to ONC, must demonstrate its competency and ability to test and certify EHRs and EHR modules.  While ONC would accept applications at anytime, the temporary certification would end when the permanent process comes into being.

In my next post, I will provide an overview of the permanent requirements and in subsequent posts, I will delve into more details.

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Speaking of which, ONC has come up with a regulation on the certification process of EHRs for meaningful use (http://healthit.hhs.gov/portal/server.pt?open=512&mode=2&objID=1745).  I will be reviewing and discussing it over the next several weeks.

Finally, President Obama has called for a federal task force to coordinate EHRs among federal agencies (http://www.whitehouse.gov/omb/assets/memoranda_2010/m10-10.pdf).  I actually think this is a good idea and should have been done last year.  Let the federal government come up with internal standards and implementation plans for Health IT.  Industry could adopt those standards if it wished to do business with the government.  This would be far easier than top-down regulation on the private sector.

Both can be read at www.pinarus.com under thought leadership.

http://www.pressofatlanticcity.com/opinion/letters/article_3da38514-1733-5c18-9731-324a4d51fb91.html

Delaware may be become ground zero for IT jobs.  With this Health IT initiative, the demand for IT in revamping the financial sector and the proximity to DC, expect Delaware to see some job growth.