More MU rules (2015)

Archived OEMR Non Profit Organization
#1

tmccormi wrote on Wednesday, December 23, 2015:

Transparency and Disclosure Requirements
The 2015 Edition Rule extends the Pricing Transparency requirement to not just the types of costs an EP/EH/CAH would pay, but may pay. It also extends the types of costs beyond just meeting MU objectives, but to implement any functionality within the scope of the certification. The regulation text provides the best definition:
“(A) Additional types of costs that a user may be required to pay to implement or use the Complete EHR or Health IT Module’s capabilities, whether to meet meaningful use objectives and measures or to achieve any other use within the scope of the health IT’s certification.” (170.523(k)(1))
Also, developers are now required to report on “Limitations that a user may encounter”. The regulation text explains it like this:
“(B) Limitations that a user may encounter in the course of implementing and using the Complete EHR or Health IT Module’s capabilities, whether to meet meaningful use objectives and measures or to achieve any other use within the scope of the health IT’s certification.” (170.523(k)(1))
This information must be present on your website and in all marketing materials.
To read ONC’s responses to comments on these regulations, see this section of the Final Rule.
REQUIRED ACTION: Update your website and any marketing material by January 14, 2015, in order to remain compliant with the requirements of certification.
Optionally, you may wish to update the certification information listed on your website and/or marketing material. The 2015 Edition Final Rule reduces the amount of information required to be posted for a 2014 Edition certificate. The new list is attached to this email, “2014 Edition Marketing Reqs.”.

Transparency Attestation
In addition to the marketing requirements, ONC has added a “Transparency Attestation” requirement. You will be required to either:

  1.   Attest to disclose the Pricing and Limitations information (as detailed above) to:

a. Anyone who asks for the information

b. In all quotations, estimates, descriptions of service in connection with the certified product

c. To all customers prior to entering into an agreement related to the certified product

  1.   Decline to attest.

REQUIRED ACTION: InfoGard will inform you of the attestation process in January 2016. You will have until March 14, 2016, complete the attestation. Failure to comply will result in certificate suspension.

Adaptations and Updates
ONC has instituted a new requirement for developers to report adaptations and updates to their ACB.
ONC defines adaptations as: “a software application designed to run on a different medium which includes the exact same capability or capabilities included in the certified Complete EHR or certified EHR Module.” (77 FR 54267, 2014 Edition Final Rule) You will be required to report any adaptations to your ACB for existing 2014 Edition certificates in addition to any new 2015 Edition certificates.
Also, you must report any updates made to the certified product that may have impacted the criteria that are also subject to the Safety-Enhanced Design (SED) criteria, 170.314(g)(3), consisting of:
· 170.314(a)(1) Computerized Provider Order Entry

· 170.314(a)(2) Drug-drug, Drug-allergy Interaction Checks

· 170.314(a)(6) Medication List

· 170.314(a)(7) Medication Allergy List

· 170.314(a)(8) Clinical Decision Support

· §170.314(a)(16) eMAR

· 170.314(a)(18) Optional – Computerized Provider Order Entry – Medications

· 170.314(a)(19) Optional – Computerized Provider Order Entry – Laboratory

· 170.314(a)(20) Optional – Computerized Provider Order Entry – Diagnostic Imaging

· 170.314(b)(3) Electronic Prescribing

· 170.314(b)(4) Clinical Information Reconciliation

· 170.314(b)(9) Optional – Clinical Information Reconciliation and Incorporation

If your product is certified to any of those criteria and you make updates related to that functionality (including bug fixes and patches), those updates must be reported to the ACB quarterly.
You can read ONC’s responses to comment on this regulation here.
REQUIRED ACTION: Starting July 1, 2016, you will be required to report quarterly any adaptations you create and any changes, updates, bug fixes, etc. that you make to your certified product related to the SED criteria. InfoGard will send out an attestation form in March 2016 to be used for this purpose. You must submit an attestation by July 1, even if no changes or adaptations were made, or risk suspension of your certificate.
From that point on, you will be required to submit an attestation every quarter (October, January, April, July…) while your certificate is valid.

Surveillance
ONC’s new surveillance requirements include “in-the-field” surveillance. InfoGard will be required to do testing with at least one user for at least 2% of all certified products. If you are selected for random surveillance, InfoGard will require your assistance setting up the testing session with one of your customers selected by InfoGard.
In addition, if InfoGard finds a non-conformity, you will be required to write and submit a corrective action plan to be approved by InfoGard. This process and all of the surveillance process is fully described in InfoGard’s CY2016 Surveillance Plan. InfoGard has submitted the Plan to ONC for approval and will post it on our website once approved.
No action is required at this time regarding surveillance, but we wanted you to be aware of the changes.

#2

sunsetsystems wrote on Wednesday, December 23, 2015:

Tony, who does this apply to? What about the user who modifies their own instance of OpenEMR and/or contributes updates to the project?

Rod

#3

tmccormi wrote on Wednesday, December 23, 2015:

It applies to anyone using OpenEMR for attestation. They could care less if it’s the user, and vendor or God himself…

Open Source is not a concept that CMS understands at all

#4

sunsetsystems wrote on Wednesday, December 23, 2015:

Will OEMR be doing the quarterly reporting of “adaptations and updates”?

If OpenEMR is selected for “surveillance”, where will the resources come from to act on that?

Rod

#5

aethelwulffe wrote on Wednesday, December 23, 2015:

  1. Tony, who is ACB in our regard? Infogard?
  2. Rod, This year OEMR will (as is absolutely required) to operate as a proper business entity.
    To wit:
    Board meetings, an organizational structure beyond the board and resource management must switch to an operational status more in line with your typical active non-profit.
    As current secretary I will be scheduling a board meeting for shortly after the beginning of the year. This board meeting must address all the issues related to the current organizational structure, including policies and procedures related to performance requirements of the board members and (for now) volunteer employees. Personally, I intend to push for electing/hiring an executive director willing to keep regular OEMR business hours (to whatever limit is available). I propose this to pursue a number of goals:
    a. Have an individual that handles daily business of OEMR with overview from the board, and not a “gang-of-ten” operation that gets nothing done.
    b. Keep an active board working towards fund-raising or otherwise providing resources for the director.
    c. Provide a dependable and formal structure for external redress, periodic reporting, marketing and community resources at a consumer friendly level. This includes product documentation, presentations, and presence in medical IT business relations.
    d. Pursue some seeming improbably exposure goals such as public media exposure and yes, an OpenEMR or at least Open Source medical software conference or expose.

As secretary, I have just been tasked to start doing my job. The next meeting should very much add your question to the agenda. Personally I feel that providing those reports and doing all the associated task should very much be the responsibility of a strong and organized OEMR.org 501©3. An appropriately funded and stable OEMR at that.
I think that there are going to be major changes required in the next decade to…well everything. Either the product goes on after that, or it doesn’t. If it is to survive, much less grow (as a movement if not a particular product) then we are going to have to operate the OEMR organization and the project management in a professional manner and start tending away from the ad-hoc or hobbiest approach.

#6

teryhill wrote on Wednesday, December 23, 2015:

Sounds like a great plan Art.

Terry

#7

tmccormi wrote on Wednesday, December 23, 2015:

Art: ACB for us is InfoGard.
Rod: What Art said. The OEMR will have to make sure we have the funds to
support this kinds of requirements going forward.

Tony McCormick, CTO


Support: 866-735-0897, Direct: 713-574-6709
My Calendar: http://bit.ly/XznvDo
“I am and always will be the optimist. The hoper of far-flung hopes and the
dreamer of improbable dreams.” — The Doctor, Season 6

On Wed, Dec 23, 2015 at 1:56 PM, Terry Hill teryhill@users.sf.net wrote:

Sounds like a great plan Art.

Terry

More MU rules (2015)
https://sourceforge.net/p/openemr/discussion/oemr_501c3/thread/176bce7e/?limit=25#521b

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#8

sunsetsystems wrote on Wednesday, December 23, 2015:

What makes sense to me is an OEMR.org membership composed of dues-paying OpenEMR users who will in turn receive the benefits of MU certification and related obligations of OEMR in the “vendor” role. If you’re not a member then you don’t get the letter that says you’ve received the software.

Wouldn’t that work better than begging for money?

Such expansion of the membership plus a member-elected Board would be integral to the nature of this effort and of being a nonprofit.

Rod

#9

bradymiller wrote on Wednesday, December 23, 2015:

Hi,

My main thoughts are grants (membership dues and begging will not be enough, although the re-branding of MU1 OpenEMR for 1k a pop did bring in a substantial amount of money).

I think most important thing right now is getting OEMR active again and bringing in active board members and going from there. With a healthy OEMR, then community can start pursuing grants.
I would like to join the OEMR board.

-brady
OpenEMR

#10

teryhill wrote on Wednesday, December 23, 2015:

you got my vote

#11

aethelwulffe wrote on Thursday, December 24, 2015:

Terry, I would gladly support your nomination to the board as well as Brady. I know you are a busy person, but think about it.

#12

teryhill wrote on Thursday, December 24, 2015:

You been in the eggnog with the mouse !!!

There are a whole bunch of people out there much more qualified than me

Thanks for the ego boost art now quit Joshun and get on to more important things.

#13

aethelwulffe wrote on Thursday, December 24, 2015:

The…uh…qualifications…uh…are pretty low. I mean…look at me.
You contribute, you are active, and you care. Besides there is probably an EEO requirement somewhere that says we have to include someone from Georgia.

#14

teryhill wrote on Thursday, December 24, 2015:

The company is based in Ga I work for Jim from My recliner in Tennessee.

I will think about it but I don’t know that’s a lot of responcibility and I am just a country boy ask Tony he can tell you.

#15

aethelwulffe wrote on Thursday, December 24, 2015:

Careful…you might offend Dr. Jack Cahn…And I am pretty sure that Tony owns a banjo.
Anyway, there are a large number of excellent board prospects that are active on this forum. One in particular comes to mind…I can’t pronouce his username, but he likes mice that sail.
In any case, being a board member and acting as a community participant are both very important roles and not exclusive of each other in the least. I encourage anyone here that feels inclined to apply themselves, or knows someone (with a lot of money) that is a good prospect for recruitment to please tender a nomination for consideration.