Medical Device Standards FAQ
All answers were provided by Christopher Lonegro, an attorney with Baker Donelson’s Intellectual Property Group.
Broadly speaking Intellectual property (IP) refers to creations of the mind, such as inventions; literary and artistic works; and names and symbols used in trade. IP is protected either by keeping it secret—which limits its benefit to both the creator and the public at large—or by legal means such as patents, copyrights and trademarks. Patents and copyrights enable public disclosure of inventions and creative works without the risk that their creators will lose the benefit of their efforts. Trademarks, on the other hand, are meant to benefit the public by protecting the names and symbols used to identify the sources of the goods and services they consume. A common thread between the three is the goal of balancing the interests of the IP holder and the public to foster innovation and creativity. The members of AAMI's technical committees and working groups put their minds together to produce standards, technical information reports and recommended practices for the medical device industry. As the product of their collective intellect, all of the work produced by committees and working groups is intellectual property that AAMI invests time and financial resources in creating and distributing for the benefit of the entire industry. These costs are significant and without the protections provided by intellectual property law, AAMI would not be able to marshal the resources needed to undertake and continue the work of developing new standards, practical support and guidance. The strength of the protections given to AAMI's intellectual property is important to the strength of the organization as a whole.
All of the standards, technical information reports, and recommended practices produced through the efforts of AAMI's technical committees and working groups are intellectual property that is protected by the copyright laws of the U.S. and other countries around the world. The same is true for standards and related materials developed by other organizations and offered to AAMI members through license agreements between AAMI and those other organizations. AAMI maintains similar copyright ownership of all the practical information, support, and guidance developed by AAMI and offered to assist AAMI members. These may be in the form of books, periodicals and newsletters or courses, conferences, and continuing education—in both physical and electronic forms. In short, virtually all of the resources offered to AAMI members are products of the mind—i.e., intellectual property—and need to be protected to ensure their longevity and availability. AAMI's intellectual property represents much of the value that AAMI offers to its members and to the greater medical device industry.
It is permissible and encouraged for AAMI members and non-members alike to reference the name of an AAMI standard or program in a lecture or article. While the content expressed in a standard or program is generally protected by copyright, their names and titles typically are not. Names and titles are how people identify the things they are talking or writing about and to prevent someone from using the name of something to identify it would make public conversation about or reference to that thing exceedingly difficult.
While names and titles are not protected by copyright, the content of AAMI materials typically is. This protection applies equally to copying a chapter, quoting a paragraph or reproducing a figure or table. But copyright law does allow for limited use of copyright protected works without the permission of the author in certain circumstances under what is termed the "fair use doctrine." Unfortunately there is no clear-cut rule as to what is or is not a fair use and the concept is among the most misapplied legal terms. Many reams of paper have been consumed by lawyers arguing over what is or is not a fair use. Typically fair use is found for socially important purposes such as comment, criticism, news reporting, teaching, and research, but each case is decided on an individual basis. Factors considered to determine fair use include the purpose of the use; the nature of the copyrighted work; the amount and substantiality of the portion used; and the effect of the use on the potential market value of the work as a whole. AAMI relies on income from sales of standards and related materials and programs to support its standards development program and so cannot permit uses that may divert or diminish that income. For that reason members and non-members alike may not reprint an entire standard or substantially all of the relevant provisions of a standard or other material without AAMI’s express written permission. Additionally, AAMI's intellectual property policy acknowledges an individual's right to use a portion of an AAMI work so long as the use is not for a commercial or for-profit purposes; does not imply an endorsement by AAMI of any products, services or expertise; and includes a reference to the source document identifying AAMI as the copyright holder. A national standard adopted by AAMI may also be submitted to a regulatory body solely for the purposes of meeting specific regulatory requirements and/or for the internal use of the regulatory body. When in doubt as to whether a use would be considered a fair use, it is recommended to consult with legal counsel, or to avoid the uncertainty altogether and request permission.
The purpose of the use does matter, but remember that there are no hard and fast rules as to whether a desired use of copyright protected AAMI materials would be considered a fair use under the law. Broadly speaking, nonprofit educational and noncommercial uses are more likely to be considered fair uses but this does not mean that all nonprofit education and noncommercial uses are fair uses. Nor does it mean that all commercial uses are not fair. Instead the determination is made by balancing the purpose of the use against the other factors above. The permission granted to individuals under the AAMI intellectual property policy to quote, print, or otherwise use or communicate portions of a standard is also limited with respect to commercial use. AAMI grants permission only for non-commercial uses so quoting portions of a standard in promotional materials for a company is not a permitted use. Even permitted non-commercial uses are limited in certain ways. For example, as noted above a permitted use cannot state or imply that AAMI endorses a product or service or that AAMI represents that a product or service meets or exceeds an AAMI standard. Additional guidance on permitted use of AAMI standards is available on the AAMI website and members are encouraged to contact AAMI if there is any doubt about an intended use.
No. An individual or company purchasing a single copy of a standard—whether in paper or electronic form−is not permitted to copy and distribute the standard to others even within the same organization. Making paper photocopies quite obviously falls within this prohibition, but placing an electronic document onto a computer network where multiple users can access it at the same time has the same effect and is similarly prohibited. If multiple individuals within an organization need to access the standard simultaneously, then the organization should buy a copy for each user or should contact AAMI about broader use rights for the entire organization.
AAMI's name and logo are trademarks used to identify it in the marketplace as the trusted source of the information that it provides. As with the names and titles of copyright protected works, an organization's name is the way that people identify it when they are talking or writing about it. Using an organization's name in this way is termed a nominative use in the parlance of trademark law and is always permissible. However, unlike its name, it is not necessary to use AAMI's logo to identify the organization when writing or talking about it. Unauthorized use of the AAMI logo raises the risk of suggesting an unintended endorsement or affiliation between AAMI and the user and is not a permissible nominative use. Anyone wishing to use the AAMI logo for any reason should seek AAMI's permission prior to doing so.
It's never fun to contemplate all of the really bad things that can happen as a result of violating—or infringing—someone else's intellectual property. This is why AAMI takes great care to respect the IP rights of others and why members should do the same. As with so many things in law, the particular consequences for any given infringement are determined on a case-by-case basis. Typically, an infringer will be ordered to stop the infringing activity, may be required to pay monetary damages, and may also be required to destroy any products or materials utilizing the infringing intellectual property. Copyright infringement carries the added risk of statutory damages of up to $150,000 per infringement and the potential for an infringer to be responsible for an IP rights-holder's attorney fees. Perhaps equally bad is the damage that infringement can do to business relationships and the trust between industry partners.
First check with your organization to determine if any copying is permitted by a license agreement with AAMI. Absent such a license, any electronic copies posted to a networked computer system should be removed with the exception of the one or several individual electronic copies that the organization has purchased rights to. Any individually purchased copies can be maintained on a private, access-controlled networked computer systems, but controls such as file passwords and file rights management should be placed on the electronic document to ensure that new copies are not made by others and that the number and identity of individuals accessing the document is in keeping with the rights purchased by the organization. By the same token, paper copies of standards distributed throughout an organization in excess of the number purchased should be collected and destroyed. It is suggested that authorized copies be put in the possession of identified custodians within the organization to ensure appropriate use and access. If paper or electronic copies have been passed on to individuals outside of your organization, then those people should be contacted and asked to return or destroy their copies and to likewise notify anyone to whom they may have provided copies. It is also requested that you let AAMI know of third-party recipients who have received copies and who may want or need to purchase a copy of their own. One last thing that organizations should consider doing if they that find that many members are sharing or duplicating a limited number of purchased copies, is purchasing a broader license that would permit the type of use they seemingly need.