Opportunities for Engaging Long-Term and Post-Acute Care Providers in Health Information Exchange Activities: Exchanging Interoperable Patient Assessment Information. Intellectual Property Issues and Government Contracts and Grants

12/01/2011

Rules concerning rights to works created under government grants or contracts are not black-and-white.27 Competing rights of the contracting agency and the grant or contract recipient need to be weighed. Generally, for work created under contract to or grant by the U.S. government, the award recipient may copyright any work subject to copyright, but the U.S. government reserves the right to use the work for government business, and to authorize others to do so. If the grant or contract recipient is to retain exclusive IP rights, that is most appropriately spelled out in the terms of the contract or grant.28 This does not appear to be the case, at least in the initial stages of development, of the instruments under review in this report. Copyright claimants to all or portions of the MDS/RAI and the IRF-PAI have asserted that their work is copyrightable. They emphasize the award recipient's rights but minimize the broad rights given to the Federal Government.29 Since the Functional Independence Measure was developed as the result of a grant from the U.S. Department of Education, contractors for the IRF-PAI base their copyrights on OMB Circular no. A-110, which allows non-profit organizations that are recipients of grants or cooperative agreements, to copyright content created under the grant or agreement.

The text from OMB Circular no. A-110 reads:

36. Intangible property.

(a) The recipient may copyright any work that is subject to copyright and was developed, or for which ownership was purchased, under an award. The federal awarding agency(ies) reserve a royalty-free, nonexclusive and irrevocable right to reproduce, publish, or otherwise use the work for federal purposes, and to authorize others to do so.

(b) Recipients are subject to applicable regulations governing patents and inventions, including government-wide regulations issued by the Department of Commerce at 37 CFR part 401, "Rights to Inventions Made by Nonprofit Organizations and Small Business Firms Under Government Grants, Contracts and Cooperative Agreements."

(c) The Federal Government has the right to:

(1) obtain, reproduce, publish or otherwise use the data first produced under an award; and

(2) authorize others to receive, reproduce, publish, or otherwise use such data for federal purposes.30

IP rights to works created under contract with federal government agencies are guided by the data rights sections of the Federal Acquisition Regulations (FARs).31 Under the rights in general provisions, unless provided otherwise in the contract, the government has unlimited rights to all data first produced under contract with civilian agencies of the Federal Government. Contractors can claim copyright in published articles, symposia proceedings, or the like, based on or containing content produced under the contract, but ordinarily must obtain permission from the contracting officer before asserting further rights to work produced through the contract. In cases where the contractor asserts rights to works produced under contract, the government customarily includes a contract clause granting the government agency a license to reproduce, prepare derivative works, distribute, perform and display the copyrighted work:

48 CFR §52.227-14 (c) Copyright--

(1) Data first produced in the performance of this contract.

The prior, express written permission of the Contracting Officer is required to establish claim to copyright subsisting in all other data first produced in the performance of this contract. When claim to copyright is made, the Contractor shall affix the applicable copyright notices of 17 U.S.C. 401 or 402 and acknowledgment of government sponsorship (including contract number) to the data when such data are delivered to the government, as well as when the data are published or deposited for registration as a published work in the U.S. Copyright Office. For data other than computer software the Contractor grants to the government, and others acting on its behalf, a paid-up, nonexclusive, irrevocable worldwide license in such copyrighted data to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, by or on behalf of the government.

(2) Data not first produced in the performance of this contract. The contractor shall not, without prior written permission of the Contracting Officer, incorporate in data delivered under this contract any data not first produced in the performance of this contract and which contains the copyright notice of 17 U.S.C. 401 or 402, unless the contractor identifies such data and grants to the government, or acquires on its behalf, a license of the same scope as set forth in subparagraph (c)(1) of this clause…

The FAR special works contract clausegives the government the right to control the release and use of data delivered under contract and in all data first produced under contract. The government also has the right to limit the release of the data and can circumscribe the right to establish copyright.32 As with the general rights in data clause, under the special works clause the contractor, with permission from the government, can incorporate previously copyrighted works into the data being delivered if the government gets the same scope of rights that it would get otherwise.

Agreements entered into in the past between the federal agencies and the award recipients who created the data sets upon which the assessment instruments are based, indicate that both the agencies and the developers took a narrow view of what appear to be the government’s rights to the works created under contract or grant, either by mandating how CMS can use the work, or by placing requirements on how and where ownership claims must be displayed. Although not addressing assessment instruments, one analyst wrote concerning copyrights and federally-funded research:

It also appears that the Federal Government does not protect their [sic] reserved rights, much less diligently exercise them on behalf of the public. OMB Circular A-110and its related CFR provisions represent a significant source of latent federal authority that could be used to enhance access to STM [Scientific, Technical and Medical] works.33

An understanding of the terms of the contracts under which the assessment instruments were developed is vital to determining whether special provisions may have been included in the contracts, statements of work, or other written agreements regarding IP issues. Without access to the language of the contracts, in particular the FAR provisions concerning rights in the data produced through the contracts, it is difficult to determine whether this narrowing of the government's general rights in works created under contract was intentional and written into the contract, approved through written agreement with the contracting officer, or simply asserted beyond the provisions of the contracts.

The push towards interoperable health information systems may give rise to additional IP issues. In December 2007, the Department of HHS informed the public by means of a Federal Register notice of the adoption of the CHI Patient Assessment standards (as well as standards for Multimedia and Allergy) and announced that the “Federal Government will require all future federal health information acquisitions to be based on CHI standards…”.34 As CMS moves towards implementing new assessment instruments (e.g., the CARE instrument) it does so with the recognition that new assessments will have to be implemented using the HIT requirements for exchanging and reusing standardized federally required patient/client assessments. CMS included a requirement that the instrument comply with CHI standards in its contract to develop the CARE instrument.35 Applying CHI standards to federally required patient assessments will support interoperability of health information if this standardized information can be exchanged and re-used across settings. However, as previously noted, IP claims often constrain the ability to freely disseminate standardized patient assessment content.

The following pages will outline the history and development of the three PAC assessment instruments currently mandated by CMS for reimbursement purposes, and will describe known IP issues. The summaries will address what the instruments are and what they are used for. Regulatory background concerning how and why the instruments were created and mandated for use will be reviewed, as well as how and by whom the instruments came to be created, and how and by whom the instruments have since been developed. Where known, the report will cover how IP issues that have previously arisen have been addressed. Understanding how federally-required patient assessments were developed in the past and the resultant IP claims may provide policy makers and others with information to support the development and standardization of patient assessment instruments for free and widespread use in an increasingly interoperable healthcare environment.

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