Quality Manual ISO/IEC Mandatory Disclosure Attestation

Transcription

1 This document explains the mandatory disclosure attestation required for product certification in the ONC Health IT Certification Program. The health IT developer must provide the disclosure language they will use for their product-version. The Drummond Group LLC ONC-ACB must have this information prior to issuing a certification. This document includes requirements for the disclosure attestation letter, as well as Drummond guidelines and examples for reference. Per ONC regulations, the disclosure attestation letter submitted will be attached to your Test Reports Summary which will be made public on Drummond Group s website. It is the language you plan on using for marketing materials and on your website. Document Created by: DRUMMOND GROUP LLC PHONE: Page 1 of 9

2 Overview of ONC Regulation This section is an overview of the requirements. For a complete explanation of the disclosure requirements, refer to the ONC 2015 Edition Final Rule found here: Regulation (k)(1)(iii) states that an EHR Module developer must conspicuously include, in plain language, the following on its website and in all marketing materials, communications statements, and other assertions related to the Complete EHR or EHR Module s certification: (A) Any additional types of costs that an EP, EH, or CAH would pay to implement the Complete EHR s or EHR Module s capabilities in order to attempt to meet meaningful use objectives and measures. (B) Limitations that a user may encounter in the course of implementing and using the Complete EHR of 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. In the Final Rule, ONC clarified that these types of costs are in addition to those costs that an EP, EH, or CAH would pay to purchase the EHR technology capabilities for which certification is required. The costs or fees may be imposed by the developer or third party to purchase, license, implement, maintain, upgrade, use, or otherwise enable and support the use of capabilities to which health IT is certified. These may be one-time or recurring costs, or both. Drummond must ensure that EHR technology developers disclose, with particularity, the types of additional costs, but does not require that the actual dollar amounts of such costs be disclosed. Limitations are, by contract or otherwise, limits on the use of any capability to which technology is certified for any purpose within the scope of the technology s certification. These limitations include, but are not limited to, technical or practical limitations of technology or its capabilities that could prevent or impair the successful implementation, configuration, customization, maintenance, support, or use of any capabilities to which the technology is certified. Limitations that could prevent or limit the use, exchange, or portability of any data generated in the course of using a certified capability must also be disclosed. *Note: EHR technology self-developers are excluded from this requirement ( (k)(1)(iii). Reference Self-Developer Exclusion in the additional information below. Additional Information Changes to the Disclosure Language An organization may change their disclosure language at any time to reflect new business policies or decisions. However, the new language must be sent to DG in the form of the attestation disclosure letter described in this document. There are no additional costs for updating disclosure language. Page 2 of 9

3 Self-Developer Exclusion Per the ONC ruling, EHR technology self-developers can be excluded from this requirement ( (k)(1)(iii). To obtain this exemption, EHR technology self-developers must submit this attestation that they are an EHR technology self-developer and their EHR technology will not be marketed or made commercially available for sale to health care providers. Reference the Disclosure Attestation Letter Instructions to include the necessary language for all attestations. Non-compliance Consequences Per the Final Rule, the ONC-ACB is responsible for ensuring compliance and determining appropriate consequences if EHR technology developers fail to disclose the information specified in (k)(1), including inaccurate or missing disclosure information. Organizations will be regularly surveyed to confirm they are properly reporting their disclosures in conjunction with their certification status. Organizations failing to conspicuously include the disclosure details on their web site and in all marketing materials, communications statements, and other assertions related to the Complete EHR or EHR Module s certification may have their product s certification status revoked. Page 3 of 9

4 Rules and Guidance on Disclosures Language The specifics of the disclosures language are left to each certifying organization, but the following rules and guidelines for ensuring transparency compliance are used by DG ONC-ACB (key words from RFC 2119). The attributed service, functionality or software MUST be referenced in human readable text and not solely in reference to the ONC criteria. For example, online portal service rather than e.1. However, the ONC criteria MAY be included for clarity. In situations where the same types of cost apply to different services, each part MAY be listed in a sentence clearly identifying the cost attributes. For example, a one-time fee is required to establish interfaces for reporting to immunization registries, cancer registries, and public health agencies. Use these questions to help guide you when writing your disclosure letter. ADDITONAL COSTS: What costs/fees are not included in the initial purchase of this software? Are these costs/fees fixed, one-time, recurring, ongoing, monthly, transaction based, annual, etc.? What software must be purchased that is not included in the initial purchase of this software? What kinds of services, functionality or software is attributed to this cost? Are there are any limitations of workstations or licenses where the software is deployed, volume of transactions or usage or associated bandwidth limitations? CONTRACTUAL OBLIGATIONS: Does a provider have to sign a contract when purchasing your product? If so, what are the terms for contractual obligation? (i.e. 1-year contract) TECHINCAL OR PRACTICAL LIMITATIONS: Are there any additional services a provider must purchase that are not included in the initial purchase? Page 4 of 9

5 Is it necessary to engage with a third party in order to use your product? To your knowledge, is there an agreement that providers must enter into with this third party? If there is a third party involved, are there any limitations to which third party the provider chooses in order to use your software? Any limitation that would inhibit a provider from using your product must be stated. ITEMS THAT DO NOT NEED TO BE INCLUDED: Software and services which are included in the normal purchase price of the EHR technology capabilities SHOULD NOT be included. For example, the purchase price includes ongoing support for full use of online patient portal for any customer. Additional software or services which an EP, EH or CAH MAY elect to obtain but which are not within the scope of the health IT s certification. For example, a separate PMS software to enable billing but not essential to meet Meaningful Use objectives and measures or to achieve any other use within the scope of the health IT s certification.. Page 5 of 9

6 Disclosure Attestation Letter Instructions Prior to issuing a certification, Drummond Group LLC (DG) must receive an attestation letter dated and signed by an authorized representative who has the legal authority to represent the company in such matters on formal company letter head stating the following: 1. The name of your organization and the product name and version seeking certification. 2. The exact disclosure language you will use for this certified product version. Please follow the rules and guidelines for this language described in this document. If this language is an update to a previously submitted disclosure attestation, please note this and the approximate date on which this new disclosure information will be in effect and displayed on your marketing materials. 3. If a self-developer of EHR technology claiming exclusion from mandatory disclosure requirements, submit this attestation that you are an EHR technology self-developer and your EHR technology will not be marketed or made commercially available for sale to health care providers. The below language from #4-6 must be included in this letter. EVERY ATTESTATION LETTER MUST INCLUDE LANGUAGE FROM 4-6: 4. Your agreement to notify DG of any and all future changes to your disclosure language for this certified product-version. 5. Your understanding and agreement that the ONC Health IT Certification Program Final Rule statement gives DG, as an ONC-ACB, the sole responsibility for ensuring compliance and determining appropriate consequences if EHR technology developers fail to disclose accurate information. 6. Your understanding and agreement that you will provide to DG copies of or be given access to any and all websites, marketing materials, communication statements, and other assertions made by your organization regarding the ONC certification status of your product in a reasonable time to ensure the disclosure information is being accurately disclosed. Document must be signed, scanned and sent to Melissa Martin, MelissaM@drummondgroup.com. The DG EHR Certification Body requires this attestation document before granting a certification on a product-version. Page 6 of 9

7 Examples of Mandatory Disclosures Some examples of certified products and attributed costs are given below. Examples 1, 2, 3, and 4 are pulled from the ONC Final Rule. Example #1 EHR technology is certified to the 314.e.1 view, download, and transmit to a 3 rd party certification criterion. However, EP must pay an ongoing monthly service fee to the EHR technology developer for it to host/administer this capability in order for the EP to meet the correlated MU objective and measure, the existence of this potential ongoing cost would need to be disclosed by the EHR technology developer. Example of Disclosure Language: This certified product-version may require ongoing monthly costs to support online patient service ( e.1). Example #2 An EHR Module is certified to the immunization registry transmission ( f.2), public health electronic lab reporting certification ( f.4) and transmission to cancer registries ( f.6) criteria. However, for the purposes of achieving MU, an EP, EH or CAH may be expected to pay a separate one-time fee for customizing the transmission interface development and configuration necessary for a state reporting agency. In addition the EHR technology developer charges a one-time fee to integrate its certified EHR technology with a hospital s other certified EHR Modules or a health information exchange organization. Example of Disclosure Language: This certified product-version may require one-time costs to establish interfaces for reporting to immunization registries, cancer registries, and public health agencies ( f.2, f.4, f.6). Support for integration of this certified product-version with other ONC certified systems may require additional one-time costs. Example #3 A Health IT Module is certified to 2014 Edition transitional of care certification criterion at (b)(1). The developer of the Health IT Module charges a yearly subscription fee for the use of the capability. In making the capability available, the developer bundles it with its own HISP. Because the developer is not a member of any trust network, users can only exchange transitions of care summaries with other users of the developer s own HISP and with users of third-party HISPs with which the developer has negotiated or is willing to negotiate a trust agreement. The developer also changes a transaction fee for each transitions of care summary sent of received via a third-party HISP (the transaction fee does not apply for transition of care summaries exchange among users of the developer s own HISP). Example of Disclosure Language: This certified product-version may require an annual subscription fee. For transitions of care summaries (b)(1) outside the product s HISP network, this certified product-version may require fees per transaction. Page 7 of 9

8 Example #4 EHR technology is certified to (b)(6) for Data Export to create a set of export summaries in real time base on a relative time and date. While the user can create a set of export summaries in real time based on relative time and date, this type of mass export is only allowed every 24 hours to reduce performance stress on the system. Example of Disclosure Language: This certified product-version is certified to Data Export criteria (B)(6) and can generate a set of export summaries in real time. However, the ability to utilize the mass export functionality for Data Export is only allowed every 24 hours to ensure optimal system performance. Page 8 of 9

9 {COMPANY LETTERHEAD} ATTN: Drummond Group, LLC North Hwy. 183 Suite B Austin, TX [Date] [Name of Organization] [Product Name-With-Version] For public release and exact language used for our website and marketing distributions: {Disclosure LANGUAGE: See instructions and examples} Additional Costs Contractual Obligations Technical or Practical Limitations This certified product-version may require (_additional costs ), ( obligations ), and ( technical and practical limitations ).. contractual We agree to notify Drummond Group of any and all future changes to our transparency and disclosures language for this certified product-version. We understand and agree that the ONC Health IT Certification Program Final Rule statement gives Drummond Group, as an ONC-ACB, the sole responsibility for ensuring compliance and determining appropriate consequences if EHR technology developers fail to divulge accurate transparency and disclosures information. We understand and agree that we will provide to Drummond Group copies of or give access to any and all websites, marketing materials, communication statements, and other assertions made by your organization regarding the ONC certification status of this product in a reasonable time to ensure the transparency and disclosures information is being accurately disclosed. [Signature Block of Authorized Senior Company Representative] [Name of Authorized Senior Company Representative] [Title of Company Representative] [Company Contact Information] Page 9 of 9