The Accreditation Council for CME's policy on the Internet states: “The accredited provider must be able to document that it owns the copyright for, or has received permissions for use of, or is otherwise permitted to use copyrighted materials within a CME activity on the Internet.”

For many of us working in the field, suddenly issues of copyright and the broader area of Intellectual Property loom as hitherto unexamined areas. Exactly what is intellectual property and how does it affect CME providers?

What Is Intellectual Property?

The world of intellectual property encompasses a wide body of federal and state laws that protect creative property such as writing, music, drawings, paintings, photography, and films. Collectively, these laws are called intellectual property law, which includes (among others) copyright, trademark, and patent laws, each applicable in various situations, and each with its own set of technical rules. When obtaining permission to use creative works, we're concerned primarily with copyright law. However, trademarks, trade secrets, and the rights of publicity and privacy sometimes come into play when permission to use certain types of works is sought.

Most of us already knew that through our faculty and teachers we could cite works created by others in a live educational environment as long as we acknowledged the source of the works. However, with the proliferation of enduring materials — especially on the Internet — everything has changed. Our legal sources tell us that plaintiff attorneys are poised to take legal action against educational organizations for what appears to be flagrant violations of these laws. Not only are we subject to U.S. law but now we are also subject to intellectual property laws of other countries. Several cases brought internationally against clients in the United States have been successfully tried, and penalties exacted.

Questions You Need to Ask

Issues involved with intellectual property and CME are as follows:

• When are permissions necessary and how do you get them?

• Who owns CME material: the CME provider, the originating faculty?

• When is it OK to use graphs or charts from another source in your CME materials?

• How do you document compliance?

• What agreements should be signed by faculty in a CME activity?

• Are there HIPAA implications associated with CME?

• Are there privacy law implications associated with CME?

• What happens when CME providers joint sponsor: Who owns the copyright, and can either co-owner do what they want with the copyrighted material?

• Can there be co-copyright owners?

• Do you know what's posted on your Web site that is in violation of intellectual property law, nationally or internationally?

First Step: Get an Audit

Intellectual property and privacy law audits should be conducted as a matter of course, and maintained in order for the CME provider to remain compliant with all of the intellectual property and privacy law changes that are evolving at such a rapidly increasing pace. A critical point of an intellectual property audit is to protect the ownership rights of the CME provider's authors who contribute the information.

Some providers may have legal counsel on staff. Can those lawyers conduct an audit? We have found a wide variation in knowledge and capability in this very specialized area among general lawyers. Even attorneys at major medical schools may not possess the specialized focus necessary to competently evaluate your risk and recommend new practices for you to implement.

An audit should involve the following review:

• Web site(s) and their contents, domain name registration, and “hyper-linking” agreements with other sites

• Repurposed CME activities on the Internet and other sources of printed and electronic enduring materials

• Internal employee instructions and employment agreements

• Faculty and “work-for-hire” agreements

• Process of obtaining written permissions

• Use of case studies that refer in any way to actual patients

• Types of attendees participating in regularly scheduled conferences — especially mortality and morbidity conferences and tumor boards

• Intellectual property registrations, and timely renewals to maintain trademarks

• European Union compliance

In summary, these intellectual property laws that are now coming of age dramatically change the way CME providers should put together their materials, and display them. Without a secure plan in place a significant violation of any of the changing laws could result in substantial fines for the CME provider, and criminal penalties for the individual responsible for any infraction of these laws, either national or international.

To gain a better understanding of the scope of intellectual property issues, please visit www.passinassociates.com and click on Intellectual Property and CME on the splash page to view two recent presentations at major CME events by CME and intellectual property attorney, Richard Krakowski, JD.

Steven M. Passin is president of the CME consulting firm, Steve Passin & Associates in Newtown, Pa. He has also served as deputy health secretary for California. Contact him at Passin@PassinAssociates.com. Richard Krakowski, JD, is special consulting attorney, intellectual property law, Steve Passin & Associates.