ONC was recently asked whether the regulatory requirements for EHR certification and meaningful use, especially some of the more patient-focused requirements, like the view, download, and transmit to a 3^rd party meaningful use objective, could implicate patents.

We want to share with you our thoughts on patents and meaningful use, and identify the proactive steps ONC is taking to understand their implications and share that understanding with the community.

Application of Patents to Health IT

The U.S. Patent and Trademark Office (USPTO) issues three types of patents: utility, design, and plant patents.  In the area of health IT, only utility patents, which include “process” or “method” patents that outline a way for performing a function or achieving an outcome, will be significantly relevant.  Patents are written with “claims,” which define the scope of the property right of the patent owner.  Generally, one must practice each and every step in a claim to infringe the claim.

Because an infringement analysis is detailed and will be fact specific, we encourage stakeholders with questions or concerns to consult a patent attorney or other patent professional.  The question of what you should do in light of any relevant patent will also likely require consultation with a patent professional.  For providers, the first step may be to review any contracts related to the use of the software that could infringe a patent.  A contract between a vendor and provider may specifically address who, when, and to what extent a party is responsible for any potential patent infringement claims, and may include an indemnification clause that would protect the provider from infringement claims.  Further, whether to obtain a license or challenge a patent (e.g., in court or through the USPTO’s reexamination process) is also something that should be carefully considered in consultation with appropriate counsel.

Patents and Meaningful Use

The overarching goal of meaningful use objectives and supporting EHR certification requirements is to improve patient care and safety.  This is achieved by promoting enhanced care coordination, medication reconciliation, improved usability of EHR technology, and patient engagement through secure channels that protect a patient’s privacy, among other things.  Adopted EHR certification criteria recite requirements with respect to data and standards to support the achievement of meaningful use objectives with interoperable EHR technology at the highest possible level, such that requirements could be implemented in many distinct ways.  The conscientious avoidance of prescriptive language for the meaningful use objectives and EHR certification criteria will therefore minimize the likelihood that any one patented method or process will cover the implementation.

 “View, Download and Transmit to a 3^rd Party”

The “view, download, and transmit to a 3^rd party” meaningful use objective is intended to facilitate patients’ access to their health information online.  Online access permits patients to review and follow provider care instructions, review their health information for errors, and easily share their health information with other providers.  These capabilities are critically important to improve patient care and safety.

The “view, download, and transmit to a 3^rd party” certification criterion adopted at 45 CFR 170.314(e)(1) includes capabilities that EHR technology must demonstrate in order to be certified.  In general, the EHR certification criterion requires technology to enable patients to view, download, and transmit their health information according to standards that promote the interoperability, security, and exchange of health information.

We believe the functionality in the view, download, and transmit to a 3^rd party EHR certification criterion could be accomplished in many ways and does not limit providers in their use of EHR technology and attempts to achieve meaningful use.  For example, patients could be provided the opportunity to view, download, and transmit their health information through provider portals that are tethered to an EHR, personal health records (PHRs), a combination of the two, or even other means.  With any of these options, we could foresee vendors uniquely designing portals or PHRs to implement the requirements of the certification criterion as well as including other capabilities that go beyond EHR certification requirements.

ONC’s Action Plan

ONC intends to work more closely with the USPTO to ensure they are aware of and have access to prior art in the health IT space, as this impacts whether a patent is approved and the validity of patents.  We also intend to seek comment on whether future regulatory requirements could implicate patents and other intellectual property rights.

We Want to Hear From You

We have established a mailbox for public input on patents and other intellectual property as they relate to certified EHR technology (ONC.Policy@hhs.gov).  If you have thoughts on this topic, particularly as they relate to our current regulatory requirements, we’d love to hear from you!  We caution, however, that we are not in a position to opine on the validity of a specific patent or its applicability to a specific product or situation.  As matters of general interest arise, whether through comments received or otherwise, we intend to inform stakeholders through appropriate channels.

For More Information

For information on patents, the patent application process, and to search patents, please visit: http://www.uspto.gov/patents/index.jsp

For more information on patents and to review useful links, please visit: http://www.aipla.org/about/iplaw/Pages/default.aspx and http://www.aipla.org/resources/Pages/Related-Links.aspx*

*The Department of Health and Human Services and the U.S. Government do not endorse any product, service, or general policies of any non-Federal entity nor are they responsible for the content of any individual organization’s web pages or materials found at or through this link.