Digital Innovations

Software, apps, databases, data, and creative works—For all your digital innovation needs!

100

2019 DI Disclosures

14

2019 DI Excl Licenses

7

2019 DI Start-ups

629k

2019 DI Revenue

Exclusive License Deals

2019: DI Start-ups

7 of 16 Start-ups Formed were Digital Innovations

DI Total Revenue

DI Licensing Revenue




Duke Startups

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kelahealth logo

kēlaHealth

SmartfaceID

springboard logo

SpringBoard Healthcare Group, LLC

holmusk logo

Holmusk USA, Inc

Unravel Data Systems, Inc

Improved Patient Outcomes (IPO)

DaVinci Education logo color

DaVinci Education

cloud pharma logo

Cloud Pharmceuticals

kēlaHealth is a software-as-service health informatics company founded by a team of surgeons, statisticians, and engineers that uses machine learning for predicting complications during surgery. Through rigorous data analysis, kēlaHealth delivers precision medicine by leveraging data from millions of patients, standardizing surgeon variability, and addressing administrative and regulatory needs for quality compliance in surgical care.

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Large-scale face identification and verification. Automatic face recognition in unconstrained conditions is subject to pose, expression, and illumination variability and is, perhaps, among the most challenging machine vision tasks. Dr. Sapiro and team has developed a unique system and method for large scale face identification and verification.

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Offering Advanced EP Education Solutions

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Holmusk builds digital behavior change programs and predictive algorithms that offer actionable insights for personalized care and population health management.

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Analytical processing of large datasets

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mHealth platform with the focus on improving patient adherence and outcomes

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  Developed in conjunction with Duke University School of Medicine, DaVinci Education (formerly LCMS Plus, Inc.) provides a web-based platform tailored to serve healthcare education, including schools of medicine, dentistry, nursing and pharmacy. DaVinci’s flagship product, Leo™, connects and consolidates many complex data sources that exist inside every health sciences institution. From calendars to curriculum […]

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Cloud-based Drug Design and Development Cloud Pharmaceuticals is committed to improving health and well-being through the computational design and rapid development of new therapies. Our proprietary design process combines artificial intelligence (AI) and cloud computing to search virtual molecular space and design novel drugs. These drugs are excellent candidates for further development and have a […]

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Protecting DI

How can we protect Digital Innovation?

Digital Innovations can be protected under different types of intellectual property laws. For example, in many countries (including the United States), computer programs (i.e., source code, object code, or scripts), screen materials, and databases can be protected under copyright laws. Two major advantages of copyright protection lie in its simplicity and low cost. Obtaining a copyright requires three things:  originality, minimal creativity, and fixation in a tangible medium.  Copyright protection does not depend on any formalities, such as a formal registration or an examination process, such as with a patent.   Importantly, copyright protection begins as soon as a work is created and put into a tangible medium.  For example, in the case of software, copyright protection would begin as soon as the author creates an original code and types it into a computer.  In addition, a copyright owner enjoys a relatively long period of protection that can last for several decades.

Databases may have limited protection under copyright law as a “compilation.” Compilations of data or compilations of pre-existing works (also known as “collective works”), may be copyrightable if the materials are selected, coordinated, or arranged in a way that the resulting work as a whole constitutes a new work.  Importantly, copyright laws specifically require that the copyright in a compilation extends only to the compilation itself (i.e. the database), and not to the underlying materials or data.

The limited protection provided to computer programs and databases through copyrights makes it imperative that software and database owners (with developers) protect their software code and databases (and underlying data) through contract law. Through an enforceable contract (e.g. a license to use the software and database), the end user can be prohibited from extracting data from the database or modifying the software for uses other than those intended by the software/database owner.

Are Digital Innovations patentable?

Copyrights protect the literal expression of a creative work (e.g., a computer program).  They do not, however, protect the underlying inventive idea or discovery (e.g., the processes, methods of using, etc.) underlying the computer program, which could have considerable commercial value. These ideas and discoveries are protectable under patent law.  The patentability of software is a tricky subject as the variations from country to country are less than clear.

1. US:

In the US, patent-eligible subject matter is defined as “any new and useful process, machine, manufacture, or composition of matter.”  Patent ineligible subject matter includes laws of nature, natural phenomena, abstract idea, and other judicial exceptions.   Recent developments in U.S. law have limited the scope of eligibility for software patents because they tend to contain abstract ideas (see, e.g., Alice Corp. v. CLS Bank International, 573 U.S._, 134 S. Ct. 2347). In Alice, the Supreme Court established a two-step process.  First, to be eligible, the Examiner must decide whether the software contains an abstract idea, and if so, whether the elements individually or in combination transform the claim into a patent-eligible invention.  Second, the Examiner must determine whether the patent involves an inventive concept (i.e., the patent must add something significantly more than just an abstract idea.  What does this mean?  The path to obtaining software patents has gotten harder.  Since the Alice case in 2014, there has been a significant decrease in the number of patent applications filed for software or computer programs.

Post-Alice, there have been several cases that elaborate on the issue of software and patent eligibility.  For example, in the case of OIP Technologies v. Amazon (788 F.3d 1359 (2015)), the patent at issue referred to a method of pricing a product for sale that included generating stats concerning prices, estimating the likely outcomes for potential prices, and selecting the price based on the estimated outcome.  The patent was held invalid for ineligible subject matter (i.e., abstract idea) because the process was “…merely conventional computer activities or routing gathering steps.”  In the case Intellectual Ventures v. Capital One (850 F.3d 1332 (2017)), the patent at issue referred a computerized price-optimization method that helps vendors automatically reach better pricing decisions through automatic estimation and measurement of actual demand to select prices by (1) testing each price of many prices by sending a first set if electronic messages over a network to device; (2) gathering within a machine-readable medium, statistics generated during the testing about how potential customers responded to the offers; (3) using a computerized system to read the statistics and to automatically determine an estimated outcome of using each of the prices for the product; (4) selecting a price at which to sell the product based on the outcome determined by the computerized system; and (5) sending a second electronic message over the network that includes determined offers to be presented to potential customers.  The Court held that simply applying an abstract idea to a computer system does not transform the idea into patentable subject matter.

While the patent landscape for software-related patents has certainly gotten more difficult since the Alice decision, it doesn’t mean that software patenting is not possible.  There are certain types of software that, when incorporated in a computer/network or a device or a machine/apparatus for technical purposes functions like control, visualization, monitoring, communications, security etc. may be patent eligible.  Such a situation was found in the case of DDR Holdings, LLC v. Hotels.com, L.P. (773 F.3d 1245 (2014), where the Court held that computer-implemented claims were patent eligible.  The Court described the invention as being directed to generating a composite web page that combines certain visual elements of a host website with content of a third-party merchant.   Specifically, the patent at issue related to an e-commerce outsourcing system that comprised: (a) a data store including a look and feel description associated with a host web page having a link correlated with a commerce object; and (b) a computer processor coupled with the data store and in communication through the internet with the host web page and programmed, upon receiving an indication that the link had been activated by a visitor computer to serve a composite web page to the visitor computer with a look and feel based on the look and description in the data store and with content based on the commerce object associated with the link.  The Court held that the claims were not an abstract idea because they did not merely recite the performance of some business practice known from the pre-internet world along with the requirement to perform it on the internet, but instead specifically utilized the computer technology in order to overcome the problem. The Court further reasoned that the additional features in the claims were “more than a drafting effort designed to monopolize the [abstract idea].”

2. China

On April 1, 2017, the State Intellectual Property Office (SIPO) revised their software patent guidelines.  The revised rules include patent eligibility for computer software and business method patents.   For example, software claims relating to “a machine-readable medium”, “a computer program product”, and “an apparatus comprising a processor configured to execute instructions on a computer-readable medium to perform steps” are now considered patent eligible.  Claims involving business methods are no longer excluded if they contain technical features.

3. Europe

Europe allows the for the patenting of certain kinds of software so long as they meet certain requirements.  The software must have novelty, inventive step, and industrial application.  Under the EPC, a computer program per se is not a patentable invention.  However, should the patent solve a technical problem in a novel and non-obvious manner, then it may be patent eligible.

Hence, the patent eligibility of computer programs is a very complex issue due to which the costs for obtaining and enforcing a patent may be costly. These requirements can be legally and technically complex, and their compliance often requires a legal counsel’s assistance.

Do I have to register with the U.S. Copyright Office in order to be protected?

A work that meets the criteria for a copyright (minimum creativity; originality) is copyright protected the moment it is created and fixed in a tangible form that is perceptible either directly or with the aid of a machine or device.  In general, registration is voluntary and relatively inexpensive (see the following link for more details on registering your copyright:  https://www.copyright.gov/help/faq/faq-register.html). However, in order to bring a lawsuit for infringement of a U.S. work, you will need to have the copyright registered.  Registration offers several advantages, such as the possible recovery of statutory damages and attorney’s fees in successful litigation.

How do I use a copyright notice with my digital innovation?

A copyright notice is an identifier placed on copies of the work to inform the world of copyright ownership.  The copyright notice generally consists of the symbol “Ó” or word “copyright” or “copr,” the name of the copyright owner, and the year of first publication (e.g., Ó2018, Duke University.  All Rights Reserved).  The use of a copyright notice is now optional and is the responsibility of the copyright owner. It does not require advance permission from, or registration with, the Copyright Office.

Are Digital Innovations only protectable under Copyrights and potentially Patent Rights?

There could be other forms of intellectual property rights associated with Digital Innovations beyond copyrights and patent rights (in this case Utility Patents). Digital Innovations such as software and databases are protectable under trade secret law (please see below). Databases in Europe could also be protectable under EU Database Rights laws beyond copyright laws.

Screen Materials like GUI’s may be protectable under Design Patents and in limited circumstances under Trade dress. Spreadsheets may be protectable under data rights that could be enforced through contracts.

Can we protect Digital Innovation as Trade Secrets?

Digital Innovations such software and databases are protectable under trade secret law. A trade secret is any non-public information that is treated as a secret and that provides a person or entity with a competitive advantage. Unlike copyrights, patents and other forms of intellectual property protection, trade secrets do not have an expiration date.

A trade secret may survive for as long as it remains secret. However, unlike private corporations, universities generally do not hold or possess trade secrets given the mission of promoting the free and public dissemination of knowledge. Trade secrets can also conflict with federal funding agencies mandates to broadly disseminate the results, data, and information that arise from the work performed utilizing federal funds. Thus, using trade secret laws to protect digital innovation in universities is not very feasible.

Can we protect Trademarks associated with Digital Innovations?

A trademark grants the owner the exclusive use of a word, name, or symbol (mark) to describe a product and distinguish it from other products in the marketplace. While Trademarks are driven by state law, one can apply to have their mark registered through the USPTO.  The application process involves having your trademark reviewed by an Examiner in the USPTO.  If the Examiner determines the mark is unique, a formal Trademark with will be granted.  The Trademark stays in effect provided the owner continues to use the trademark in commerce and complies with renewal requirements (e.g., pays all required fees).

Trademarks can protect the name of a software company, its products and taglines, and prevent competitors from using similar names. Trademarks protect software brands, but not the software (or code) or database itself (or underlying data). In order to initially claim a trademark, add a superscript “TM” or “SM” after the proposed brand name depending on whether it is a product or service. The name should uniquely describe your company or product(s) and not be confusing with other registered trademarks. It is advised to search the trademark database to ensure that nobody is currently using your mark.

Duke OTC can provide some limited support with trademarks associated with digital innovations that have been disclosed to OTC are currently in the process of being commercialized. For other kinds of trademarks, please contact the Duke Office of Trademark Licensing.

Still have questions?

Contact Dinesh, he can help.

Ownership in DI

Who owns a Digital Innovation that has been developed at Duke?

Inventions and associated Patent Rights in Digital Innovation are governed by Duke’s Intellectual Property Policy. If the Digital Innovation was funded under federal grant money, ownership of patent rights associated with the invention vests with Duke under the Bayh Dole Act.

As regards copyrights and other intellectual property rights (excluding patent rights), notwithstanding the general principles respecting individual ownership expressed in Duke’s copyright policy, ownership of such intellectual property rights arising in certain categories of academic works (i.e., works primarily related to the teaching or research missions of the university) listed below shall vest (as works for hire or the equivalent) in Duke:

  • Works supported by grants or contracts (internal, federal, state, industry etc,) shall be governed according to the terms and conditions of such grants or contracts (which generally assign ownership to Duke) or, in the event such grants or contracts are silent as to intellectual property rights, such intellectual property will be owned by Duke.
  • Works supported by grants, extraordinary allowance or subventions (whether in money or money’s worth, and whether or not supported by outside sources under contract), when designated as such in advance by the University.
  • Databases and similar collections of information which are obtained primarily on behalf of schools or departments rather than individuals, or which involve issues of privacy (as in the case of medical patients or identifiable human subjects) or require approval by the University’s Institutional Review Board.
  • Computer programs, when the programs are primarily created to perform utilitarian tasks.
  • Collaborative works by persons working as members of the Duke community, when numerous individual original contributions are indistinctly merged, as a practical matter, into a new and distinct work fixed in a tangible medium of embodiment, and the individual creators have not entered into an agreement with respect to joint authorship.

What is “work for hire” and who owns the copyright in works developed by an employee?

Duke employees include faculty, staff, researchers, clinicians, post-doctoral fellows, graduate students and undergraduate students who (1) receive a salary from Duke and/or (2) are working under a third party contract (e.g., Federal Funding). Under U.S. copyright law, generally, a copyrightable work (which includes computer programs, databases, screen materials and creative works) created by an employee within the scope of his or her employment is a work made for hire.

The employer for whom the work is made is the “author” of the work for copyright purposes and is also the owner of the work’s copyright. Unless the parties have agreed otherwise in a signed written document, the employer or hiring party owns the copyright of a work made for hire.

Who owns the digital innovation if it was developed under grant funding?

Ownership of intellectual property rights (patent rights, copyrights etc.) associated with Digital Innovations (software, databases, screen materials, creative works etc.) supported by grants or contracts (internal, federal, state, industry etc,) shall be governed according to the terms and conditions of such grants or contracts (which generally assign ownership to Duke) or, in the event such grants or contracts are silent as to intellectual property rights, such intellectual property will be owned by Duke according to Duke IP/Copyright policies or laws/regulations.

For example, when a federal grant (NIH, NSF, DARPA, etc) is received and administered by Duke University and its affiliates, ownership of intellectual property rights including patent rights (under the Bayh Dole Act) and copyrights generally (under OMB Circular A-110) are assigned to the grantee i.e. Duke University.

I am an undergraduate student at Duke developing or planning to develop a digital innovation. Who owns the IP rights in this case?

If you are Duke undergraduate student who is developing a digital innovation and is

  • (i) not being paid a salary by Duke, or
  • (ii) not using substantial Duke resources (beyond standard resources provided to all Duke students like computers or cloud space etc.) or
  • (iii) not using funds awarded/administered by Duke or other Third Party or,
  • (iv) collaborating with Duke employees (faculty, staff and even Duke students employed by Duke) in the Digital Innovation development process,

then you would own all the IP rights associated with your contribution towards developing the digital innovation.

A common example would be an undergraduate student (non-Duke employee) who independently develops a digital innovation in the dorm where he or she resides.

Duke may assert some or all ownership rights to IP associated with a digital innovation if a student is:

  • employed by Duke
  • or is using substantial Duke resources
  • or using Duke or other Third-Party funds
  • or is collaborating with Duke employees.

If you are a student employed by Duke, then Duke could assert ownership to the IP rights associated with the digital innovation unless Duke OTC determines that the development of the digital innovation was outside of your scope of employment at Duke University or did not use Duke funds/substantial resources.

For this, you will need to complete and submit to Duke OTC an invention disclosure form (IDF).  The IDF will be reviewed by Duke OTC to ascertain the facts surrounding the development of the digital innovation.

I would like to hire an independent contractor or collaborate with an outside vendor to develop a digital innovation. Who owns the IP rights in this case?

If you are working with an outside vendor who is not acting as an independent contractor providing consulting services (IT development) for a fee, then please contact Dinesh Divakaran.

An example of such an outside vendor is an IT company wanting to collaborate with you in developing or piloting a product prototype that they have interest in commercializing. Duke OTC may be able to assist you in protecting your IP interests as a Duke inventor/developer and explore joint IP ownership scenarios with such a vendor.

If you are working with an independent contractor (for example a software development consultant) using grant monies or internal funds administered by Duke University, it is critical to work through Duke Procurement and use a “work for hire” contract to engage the vendor services.

Under the “work for hire” contract, the intellectual property rights associated with the Digital Innovation will be owned by Duke University. In the absence of a written “work for hire” contract, it is possible that the vendor may assert ownership rights to the digital innovation which can create immense complications.

I would like to collaborate with another university or private company to develop my digital innovation. Who owns the IP rights in this case?

If you would like to work with another university/non-profit or private company to develop a digital innovation and you are using grant monies or internal funds than it is critical to work through Office of Research Administration (if you are employee of Duke University) or Office of Research Support (if you are employee of Duke Health).

It is advised to use a research contract or sub-contract or collaborative research agreement to collaborate with another university or private company.

The research contract or sub-contract will have terms for joint ownership of IP created under collaborations. Duke OTC can assist in negotiating and executing an Inter-Institutional Agreement (IIA) for management of joint IP with another university. There is also the option to work through Duke Procurement under a “work for hire” agreement where Duke will own the IP associated with the digital innovation developed under the agreement.

Still have questions?

Contact Dinesh, he can help.

DI in Health

Please review the following Roadmap to help you understand the path to Digital Commercialization of Health Products at Duke.

Digital Innovation Roadmap

Download Digital Health Innovations Roadmap PDF

Conflict of Interest Questions to Think About

1. Is there any Duke or individual MD/staff ownership?

2. If any conflict, identify if management plan has been executed.

3. Is there data sensitivity (PHI, credit cards, intellectual property, student information, social security numbers, etc.)?

Research Integrity Office (RIO)

Privacy Questions to Think About

1. Approved Research protocol vs. quality/operational?

  • If state research, review if exempt or retrospective review
  • If quality/operational, identify DIHI grant or DUHS Administrator who sponsors project?

2. What is the origin/source of data?

3. What data elements will be sourced?

4. Evaluate if de-identified or LDS is sufficient

5. Is the plan to move any PHI outside DUHS?

Information Security Questions to Think About

1. Is all sensitive data encrypted in transit?

2. Is the release of data to all external parties authorized and approved by the Institutional Review Board (IRB)?

3. Is Duke involved in the created of (or paying a vendor to create) web or mobile technology?

4. Does the company need access to the Duke network?

Still have questions?

Contact Dinesh, he can help.

Commercialization of DI

HOW CAN WE COMMERCIALIZE DIGITAL INNOVATION THAT HAS BEEN DEVELOPED AT DUKE?

The primary process of commercializing Digital Innovation has always been licensing. Licensing of Digital Innovation has primarily been based on copyrights and contract law, but could also include other forms of IP including patent rights, trademarks, data rights etc. Sometimes licensing of Digital Innovation is based on a combination of IP rights and contract law terms. The different types of Digital Innovation Licenses are software licenses, database licenses, data license, creative works licenses, end-user license etc.

WHAT IS A SOFTWARE LICENSE? A DATABASE LICENSE? A DATA LICENSE? A CREATIVE WORKS LICENSE?

A software license is a legal instrument (usually by way of contract law, with or without printed material) governing the use or redistribution of software under copyrights and contract law. Under United States copyright law, almost all software is copyright protected, in source code as also object code form. A typical software license grants the licensee, permission to use or sometimes modify the software in ways where such a use or modification would otherwise potentially constitute copyright infringement of the software owner’s rights under copyright law. An open source license is also essentially a software license.

A database license is also similarly based on copyrights on the database compilation along with contract law to protect the underlying data. If the software has associated patent rights or trademarks, the software license may include these IP rights also.

A pure data license without associated copyrights on a database compilation could be based on contract law only.

A creative works license is similar to software and database license and based on copyrights and contract law.

HOW DOES DUKE LICENSE DIGITAL INNOVATION?

Duke OTC supports licensing of Digital Innovation based on software, databases and creative works. These licenses could be exclusive proprietary licenses (for example a software startup spinning out of Duke) or non-exclusive proprietary licenses (when licensing to more than one entity) or academic research licenses (when licensing to other academic institutions) or open source/open data licenses (for open licensing) or evaluation licenses (for evaluation purposes only) or end-user licenses (when licensing to end users).

The decision between exclusive or non-exclusive licensing can also be based on Duke’s ownership rights i.e. sole ownership vs joint ownership. Duke OTC also has some limited ability to support “on demand” or cloud-based delivery licensing models for Digital Innovation including Software as a Service (SaaS) and Data as a Service (DaaS) models on a case by case basis.

WHAT ARE DERIVATIVE RIGHTS? WHY ARE DERIVATIVE RIGHTS IMPORTANT IN LICENSING DIGITAL INNOVATION?

The right to create derivative works is one of the exclusive rights of a copyright holder. This modification or adaptation right is often considered one of the most powerful of all the exclusive rights in copyright, because the right to adapt and modify permits the grantee the right to improve or add to a copyrighted work and creates new copyrights that could vest in the developer of the derivative work, subject to the copyright holder’s original rights in the preexisting work.

It is important to consider and protect the original owner’s derivative rights when licensing Digital Innovation. For example, in software, derivative rights could be based on source or object code. This is primarily done by referring to derivative rights in a license contract and appropriately contract law.

Still have questions?

Contact Dinesh, he can help.

Disseminating DI for Research

WHAT ARE MY OBLIGATIONS AS A RESEARCHER/INNOVATOR WITH REGARDS TO DISSEMINATION OF SCIENTIFIC RESULTS IN PROJECTS FUNDED BY FEDERAL AGENCIES LIKE NIH AND NSF?

Data sharing policies related to research projects funded by federal agencies require investigators to share with other academic researchers, at no more than incremental cost and within a reasonable time, the primary data, samples, physical collections and other supporting materials created or gathered in the course of work. Data, in this case, means recorded information, regardless of the form or media on which it may be recorded, and includes:

  • writings,
  • films,
  • sound recordings,
  • pictorial reproductions, drawings, designs, or other graphic representations,
  • procedural manuals,
  • forms,
  • diagrams,
  • workflow charts,
  • equipment descriptions,
  • data files, data processing or computer programs(software),
  • statistical records,
  • and other research data.

Data Management Plans in research grant proposals describe the strategy for providing other academic researchers within the scientific community access to relevant data and supporting materials. This data sharing obligation is within the academic scientific community and does not extend to commercial researchers in private industry.

DO THE DATA SHARING OBLIGATIONS UNDER FEDERAL RESEARCH GRANTS MEAN THAT WE HAVE TO USE OPEN LICENSING (OPEN SOURCE/OPEN DATA) OR THE PUBLIC DOMAIN TO DISSEMINATE SCIENTIFIC RESULTS?

Dissemination or sharing of digital innovation funded under federal research dollars including software, databases/data, creative works and associated documentation to the scientific research community is essential to meeting data sharing obligations of federally sponsored research. This sharing needs to be at no more than incremental cost and within a reasonable time.

Given that digital innovations like software code, databases and creative works funded by federal research can be shared with other researchers electronically, the incremental cost is generally minimal and the dissemination is quick.

Public Domain (dedication to the public domain) or Open Licensing (open source for software, open data for databases/data or creative commons for creative works) are two of the mechanisms available for dissemination of scientific results. There are other mechanisms available for dissemination.

WHAT ARE THE DIFFERENT MECHANISMS AVAILABLE TO DISSEMINATE SCIENTIFIC RESULTS?

The mechanisms available to disseminate scientific results associated with Digital Innovations to the research community include:

  1. Evaluation Licenses/Shareware
  2. Academic Research Licenses
  3. Open Licenses (Open Source/Open Data/Creative Commons)
  4. Public Domain Dedication/Freeware

Public domain deduction or Freeware could adversely impact the technology translation and commercialization potential of digital innovations. It also provides little to no attribution to the developers/authors.

Open Licenses, like open source, in turn, could limit the translation and commercialization potential of digital innovations.

The other mechanisms that generally do not impact the translation or commercialization potential of digital innovations include evaluation licenses (generally used with non-academic entities) and academic research licenses (used with academic entities).

HOW DO I CHOOSE WHICH DISSEMINATION MECHANISM TO USE?

Please contact Duke OTC if you would like to use evaluation licenses or academic research licenses for dissemination. We have template agreements that we can use to help you in the dissemination process. We are also a proponent of responsible open licensing. If you would like to use the public domain or open licensing please be aware that some amount of diligence is generally required.

Determining and asserting ownership rights (sole ownership or joint ownership or absence of ownership) in the digital innovation would be the first step. Based on the ownership, determining the extent of exploitation rights or distribution rights for potential dissemination (third-party proprietary code, open source code, associated licenses, compatibility of associated licenses etc.) could the next step in selecting the public domain or an open licensing mechanism.

Still need help or advice in choosing an appropriate open licensing mechanism?

Contact Dinesh, he can help.

Open Source & Open Data

WHAT IS OPEN SOURCE SOFTWARE? IS IT THE SAME AS FREE SOFTWARE?

Open-source software is a type of computer software whose source code is released under an open source license in which the copyright holder grants users the rights to study, change, and distribute the software to anyone and for any purpose.

Open source licenses are software licenses that comply with the Open Source Definition — in brief, they allow software to be freely used, modified, and shared. The Open Source Initiative’s (OSI) definition of open source is recognized by governments internationally as the standard or de facto definition.

Free software and open source software are two terms for the same thing: software released under licenses that guarantee users a certain specific set of freedoms provided users comply with the terms of the license.

CAN I RESTRICT HOW PEOPLE USE AN OPEN SOURCE LICENSED PROGRAM? CAN I USE AN APPROVED OPEN SOURCE LICENSE AND FURTHER RESTRICT IT FOR ACADEMIC USE ONLY? CAN OPEN SOURCE SOFTWARE BE USED FOR COMMERCIAL PURPOSES?

No. The freedom to use the open sourced software program for any purpose, including commercial, is part of the Open Source Definition. Open source licenses do not discriminate against fields of endeavor whether commercial or academic. As such, we cannot use an approved open source license and then put additional restrictions restricting it for academic use.

WHAT ARE THE TYPES OF OPEN SOURCE LICENSES? WHAT IS A COPYLEFT LICENSE? HOW IS IT DIFFERENT FROM A PERMISSIVE LICENSE?

There are two main types of open source licenses: copyleft licenses and permissive licenses.

Copyleft refers to open source licenses that allow users to create derivative works but require the users to use the same license as the original work to distribute the new work including the derivatives.

For example, if you develop some source code and release it under a copyleft license, and then someone else modifies that software and distributes their modified version, then this modified version must also be licensed under the same copyleft license (or an upward compatible copyleft license) — including any new code written specifically to go into the modified version. Both the original and the new work are effectively open source; the copyleft license is “viral” or “sharealike” in nature and simply ensures that requirement to open source is perpetuated to all downstream derivatives.

Most copyleft licenses are open source, but not all open source licenses are copyleft. When an open source license is not copyleft, that means software released under that license can be used as part of programs distributed under other licenses, including proprietary (non-open source) licenses. Such licenses are usually called either non-copyleft or permissive licenses.

A permissive license is simply a non-copyleft open source license — one that guarantees the freedoms to use, modify, and redistribute, but that permits proprietary derivative works which do not need to be open sourced.

WHEN SHOULD I OPEN SOURCE SOFTWARE? WHAT IF THE SOFTWARE HAS COMMERCIAL POTENTIAL? WHAT OPEN SOURCE LICENSE SHOULD I USE?

If the digital innovators feel that the software they developed has commercial potential now or could be commercialized in the future, innovators are advised to submit an invention disclosure on the software and consult with Duke OTC prior to open sourcing the software.

Dissemination or sharing of digital innovation funded under federal research dollars including software, to the scientific research community is essential to meeting data sharing obligations of federally sponsored research. Open source licensing is one of the mechanisms available to meet these obligations and Duke OTC can help select an open source license or other mechanisms like academic research licenses to meet our data sharing obligations.

In selecting an open source license, diligence is required. To start it is absolutely critical to determining the copyright ownership of the code i.e. does Duke own all the copyrights in the code or is ownership shared with other like other universities, companies or individuals.

Copyright ownership could influence the selection of an open source license. It is also important to determine if all the code was developed at Duke by Duke employees from scratch or does the code contain some third-party code including open source code or dependencies. Presence of third-party code, especially proprietary code, may restrict the ability to open source software. Presence of third-party open source code, especially third-party open source code subject to copyleft licenses, can be a complex issue and could influence the selection of open source licenses due to license compatibility issues between different open source licenses.

WHAT OPEN SOURCE LICENSES DOES DUKE OTC RECOMMEND?

If digital innovators feel that the software they developed has or could have commercial potential, they are advised to submit an invention disclosure on the software and consult with Duke OTC for advice on open sourcing the software.

For Duke owned software innovations (i.e. software not containing any third-party code or dependencies) with limited commercial potential or research software tools, Duke OTC generally recommends the use of copyleft or permissive licenses which do not have patent license grant clauses. The copyleft licenses that Duke OTC supports for use with source code owned by Duke University are:

Duke OTC does not recommend the use of copyleft licenses that contain implicit patent license grants like the later versions of GNU General Public Licenses like GNU General Public License, Version 3 (GPL 3.0) or GNU Library General Public License, Version 3.1 (LGPL 3.1). However, if innovators need to use these license, Duke OTC could consider requests to release copyright ownership to the innovators so that they can use these open source licenses under their personal copyrights. Please contact Duke OTC for further details.

The popular permissive licenses that Duke OTC recommends are:

Due to patent grant language in the Apache License 2.0, Duke OTC supports the use of Apache License 2.0 on a case by case basis. Please contact Duke OTC for further details.

CAN OPEN SOURCE SOFTWARE BE COMMERCIALIZED OR MONETIZED?

Open Source Software can be commercialized and monetized. One can sell services based on the code (i.e., sell your time), sell warranties and other assurances, sell customization and maintenance work, license the trademark, etc. There are several business models for commercializing/monetizing open source software. If one is the owner of the original copyrights in open source software, one could also dual license the code under proprietary non-exclusive licenses.

Please contact Duke OTC if you would like to explore commercialization of Duke owned open source software.

WHAT IS OPEN DATA?

Open data is the idea that some data should be freely available to everyone to use and republish as they wish, without restrictions from copyright, patents or other mechanisms of control. The goals of the open data movement are similar to the open source movement with software.

WHEN SHOULD I USE OPEN DATA? WHAT IF THE DATA HAS COMMERCIAL POTENTIAL? WHAT OPEN DATA LICENSE SHOULD I USE?

If the digital innovators feel that the database/data they developed has commercial potential now or could be commercialized in the future, innovators are advised to submit an invention disclosure on the software and consult with Duke OTC prior to open licensing the database/data.

Dissemination or sharing of digital innovation funded under federal research dollars including databases/data, to the scientific research community is essential to meeting data sharing obligations of federally sponsored research. Open data licensing is one of the mechanisms available to meet these obligations and Duke OTC can help select an open data license or other mechanisms like academic data use or data sharing agreements to meet our data sharing obligations.

In selecting an open data license, diligence is required including determining ownership of data, use of third-party data etc.

If your database contains Patent Health Information (PHI), please contact IRB at the University or Compliance at the Health System for meeting data protection obligations including HIPAA.

WHAT OPEN DATA LICENSES DOES DUKE OTC RECOMMEND?

If digital innovators feel that the database/data they developed or collected has or could have commercial potential, they are advised to submit an invention disclosure on the database/data and consult with Duke OTC for advice on open licensing the data. For Duke owned databases (i.e. databases not containing any third-party data or linked data) with limited commercial potential or research databases, Duke OTC generally recommends the use of Creative Commons licenses.

Creative Commons licenses should not be used with software but can be used with databases since a database is copyrightable (with regards to the compilation). If digital innovators would like to disseminate data to the scientific community but retain commercialization options for the future, they would be advised to use a non-commercial version of the creative commons licenses like CC-BY-NC-SA 4.0 which would also require creators of derivative works to use the same license. They could further restrict derivative rights completely by using CC-BY-NC-ND 4.0.

WHAT IF I WANT TO USE OPEN DATA COMMONS LICENSES? WHAT IF I WANT TO DEDICATE THE DATABASE/DATA TO THE PUBLIC DOMAIN?

Open data commons licenses like Open Data Commons Open Database License (ODbL) and Open Data Commons Attribution License can also be used to disseminate data which require attribution.

However, please note that these licenses give full commercialization rights to the users. Please contact Duke OTC is you would like to dedicate the database/data to the public domain or use public domain licenses like CCO or PDDL.

Please also note that dedication to public domain or use of public domain licenses may not provide attribution.

Still have questions?

Contact Dinesh, he can help.

Creative Works

How can creative works be protected?

Creative works can be protected under copyrights. Creative works other than digital innovations like software, screen materials, websites and databases that can be copyrighted include:

  • literary works including manuals, books, etc.
  • scientific and technical papers
  • online writing, such as a blog or series of articles
  • musical works and sound recordings, including lyrics
  • movies and other audiovisual works
  • pictorial works (includes maps and architectural plans), graphics, sculpture
  • pantomimes and choreographic works (if they have been recorded)

Publication is not necessary for copyrighting a creative work, but your creative work must somehow be preserved in some form or be able to be reproduced, to be copyrighted.

What type of creative works cannot be protected?

Creative works that are not fixed in some tangible form of expression cannot be copyrighted. These include:

  • Ideas, procedures, methods, systems, processes, concepts, principles, discoveries, or devises, as distinguished from a description, explanation, or illustration.
  • Titles, names, short phrases, and slogans. (You may be able to trademark or service mark these.)
  • A speech or lecture that isn’t recorded or written out.
  • Familiar symbols or designs, mere variations of typographic ornamentation, lettering or coloring
  • Mere listings of ingredients or contents (but a recipe with instructions can be copyrighted)
  • “Common Property” works that have no original authorship, for example, standard calendars, tape measures and rules, height/weight charts, lists or tables taken from public documents or other common sources.
  • Works that are in the public domain, for which the copyright has expired.

Who owns a creative work that has been developed at Duke?

As regards copyrights and other intellectual property rights (excluding patent rights), notwithstanding the general principles respecting individual ownership expressed in Duke’s copyright policy, ownership of such intellectual property rights arising in certain categories of academic works  including creative works (i.e., works primarily related to the teaching or research missions of the university) listed below shall vest (as works for hire or the equivalent) in Duke:

  • Works supported by grants or contracts (internal, federal, state, industry etc,) shall be governed according to the terms and conditions of such grants or contracts (which generally assign ownership to Duke) or, in the event such grants or contracts are silent as to intellectual property rights, such intellectual property will be owned by Duke.
  • Works supported by grants, extraordinary allowance or subventions (whether in money or money’s worth, and whether or not supported by outside sources under contract), when designated as such in advance by the University.
  • Databases and similar collections of information which are obtained primarily on behalf of schools or departments rather than individuals, or which involve issues of privacy (as in the case of medical patients or identifiable human subjects) or require approval by the University’s Institutional Review Board.
  • Computer programs, when the programs are primarily created to perform utilitarian tasks.
  • Works by persons working as members of the Duke community, when numerous individual original contributions are indistinctly merged, as a practical matter, into a new and distinct work fixed in a tangible medium of embodiment, and the individual creators have not entered into an agreement with respect to joint authorship.

Do I have to register my creative work with the U.S. Copyright Office in order to be protected?

Works are under copyright protection the moment they are created and fixed in a tangible form that it is perceptible either directly or with the aid of a machine or device. In general, registration is voluntary and relatively inexpensive. Copyright exists from the moment the work is created. You will have to register, however, if you wish to bring a lawsuit for infringement of a U.S. work. Registered works may be eligible for statutory damages and attorney’s fees in successful litigation.

How do I use a copyright notice with my digital innovation?

In copyright law, a copyright notice is a notice of statutorily prescribed form that informs users of the underlying claim to copyright ownership in a published work. When a creative work is developed to be published, shared or licensed under the authority of the copyright owner, a notice of copyright may be placed on the work. The use of the notice is the responsibility of the copyright owner and does not require permission from, or registration with, the U.S. Copyright Office.

Use of the notice informs the public that a creative work is protected by copyright, identifies the copyright owner, and shows the year of first. US law no longer requires the use of a copyright notice, although placing it on a work does confer certain benefits to the copyright holder. The Copyright Office has issued regulations concerning the position of the notice and methods of affixation. Generally, the copyright notice should be placed in such a way that it gives reasonable notice of the claim of copyright. The notice should be permanently legible to an ordinary user of the work under normal conditions of use and should not be concealed from view upon reasonable examination.

For example, Copyright notices for Duke owned creative works can be added as given below:

Copyright 2018. Duke University. All Rights Reserved.

Copyright 2015 – 2018. Duke University. All Rights Reserved.

How can I disseminate my creative work openly?

Creative Commons licenses can be used to disseminate creative works openly. If authors would like to disseminate a creative work but retain commercialization options for the future and restrict users rights to create derivatives, they would be advised to use a non-commercial version of the creative commons licenses like CC-BY-NC-ND 4.0.

Can I commercialize or monetize my creative work?

Yes. If the creative work is owned by Duke University, Duke OTC can assist with commercialization efforts. Even if you used a Creative Commons license to disseminate your creative work, as long as you used a non-commercial version of the creative commons license, commercial licenses can still be used to monetize the work.

Still have questions?

Contact Dinesh, he can help.

Digital Innovations Team

If you are a Duke University or Duke Health employee, paid student, researcher, or faculty member, Duke OTC’s Digital Innovations team can help you address any questions regarding digital innovations.

Dinesh Divakaran
Dinesh Divakaran, Director, Digital Innovations
David Chang
David Chang Villacreses,
Assistant Director, Digital Innovations

Data Licensing Policy

Duke University and Duke University Health System
Licensing Principles and Income Sharing of Data from Human Sources Policy

I. Preamble and Objectives

The mission of Duke University (the “University”) includes the promotion of research and the expansion of knowledge. The mission of Duke University Health System (“DUHS”)1 is the provision of high-quality health care and innovation to build healthy communities. The purposes of the University and DUHS (collectively “Duke”) may be furthered by licensing certain data to third parties for use or study. Through such licensing arrangements, Duke believes data can be used to benefit society at large. This dissemination of data will be consistent with Duke’s efforts to promote open science.

Duke believes that it can best serve its aims and promote the relevance of its research endeavors by adopting this policy to set forth two sets of standards:

A. The principles governing the nature of licensing transactions of data derived from human sources that Duke will pursue with third parties (Section II, below); and

B. The principles for sharing a portion of the income realized from these data licensing transactions with those persons who have made significant intellectual contributions to the creation of the licensed data derived from human sources (Section III, below).2

1 For the purposes of this Policy, “DUHS” includes DUHS’ affiliates—Duke PRMO, LLC, Duke Integrated Network, Inc., and Duke University Affiliated Physicians.
2 At institutions of higher education, sharing revenue long has been regarded as a means to incentivize the creation by faculty of intellectual property, ownership of which rests in the institution itself. Prior to the adoption of this policy, however, Duke had not provided for any similar mechanism for sharing income with persons who contributed significantly to the creation of valuable data. Duke is adopting this policy, in part, to codify Duke’s approaches to opportunities to share data derived from human sources through licensing transactions and other collaborations, whether income-producing or not, as well as to incentivize persons to create data of significance and importance.

II. Principles for Data Sharing and Licensing Transactions

In deciding whether to share or to out-license data derived from human sources, Duke will adhere to the following principles:

A. Promote Duke’s academic policy of encouraging scientific research and scholarship
and improving medical care;

B. Serve the public interest by ensuring the likelihood that data, or innovations that may be developed from them, will be made readily available to the public for research and development, including for commercial uses, through a selected commercial or noncommercial partner;

C. Make available, through public posting or private distribution, information to individuals whose data are collected so that those persons can become reasonably aware of how their data may be used for research and development purposes;

D. Presume generally and preferably, subject to exceptions in the discretion of the Responsible Officials, that data should be de-identified or configured as a limited data set, in accordance with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule; that data should be non-exclusively licensed; and that licensees should be required to obtain Duke’s prior approval to sublicense to or share data with other parties; and that data cannot be shared in a way that would transfer
ownership; and

E. Receive fair market value for data shared through licensing transactions, thus providing tangible reward to members of the Duke community who create or enhance data to support Duke’s mission.

The Responsible Officials shall seek input from the President of the University in considering whether entering into a data licensing transaction is in the best interests of the University and DUHS if the transaction involves data that, in the judgment of either Responsible Official, could,

(i) be opposed to the fundamental values of Duke,
(ii) involve a particularly large data set that may implicate privacy and/or unusually important ethical considerations, or
(iii) stigmatize discrete and insular protected class groups or populations.

III. Principles for Income Sharing

A. Data Enhancers

Duke holds many forms of data, not all of which will give rise to income sharing under this policy when licensed for use by, or shared with, third parties. To be eligible for income sharing under this policy, a Covered Person as defined in Implementation Procedures, must have contributed individually identifiable creativity, ingenuity, and intellectual effort to the data collection or curation that gave the data their licensable value; a Covered Person who meets this standard shall be considered a “Data Enhancer.” Duke will not rely solely upon the representation of a Covered Person who asserts that he or she is a Data Enhancer or is a sole Data Enhancer. Duke instead will conduct its own diligence as to whether the person meets this policy’s standard to be considered a Data Enhancer and, if so, whether other Duke community members also meet the standard.

Duke anticipates that there will be certain frequently occurring scenarios in which there will be no Covered Person who meets the definition of a Data Enhancer, such that Net Revenue (as defined below) will not be shared under this policy. Some of these include:

i. Data created, collected and/or stored in the standard operations of Duke, including, for example, the routine delivery of clinical care.

ii. Data to which ingenuity and creativity have been applied, but the Duke role or job position specifically requires the application of such qualities to the daily work of the Duke faculty and staff member.

Additionally, if Data are included or contemplated as part of a broader intellectual property license, income sharing will run through the Policy on Inventions, Patents and Technology Transfer and no additional income share will be given under this policy.

B. Net Revenue

For all data licensing transactions, Duke seeks to obtain fair market value for its data.

The “Net Revenue” from any data licensing transaction will be calculated by subtracting, from the total monetary revenue received, (i) the direct costs of providing the data to the licensee, if not reimbursed by the licensee and (ii) 10% of the total revenue received, the latter of which is intended to recapture Duke’s costs in the original collection and storage of the data.

In the sole discretion of the Responsible Officials, as defined in Implementation Procedures, Duke instead may elect to calculate Net Revenue by deducting, from total monetary revenue received, any ascertainable actual costs from gathering, configuring, storing or otherwise creating the licensable value of the data.3

3 Such costs may include, for example, any Duke cost-sharing under outside grant funding or Duke special dispensations or dedicated funds made available for the collection or analysis of the data.

C. Apportionment of Net Revenue

When no Data Enhancer is identified, the Responsible Officials will apportion the Net Revenue from a data licensing transaction, whether the data is created solely by the University, solely by DUHS or jointly, among the involved Duke entities on an equitable basis, which most often will be an equal basis.

If a Data Enhancer is identified, Duke intends to share Net Revenue as set forth below:

30% – Data Enhancer(s)
35% – DU
35% – DUHS

Implementation Procedure

I. Scope

This policy establishes Duke’s position with respect to sharing income generated through data licensing transactions. However, this policy does not alter or amend the ownership interests that Duke or other persons have in data under other Duke policies, including the Duke University Policy on Intellectual Policy Rights and the Policy on Research Records: Sharing, Retention and Ownership. This policy does not alter or amend Duke’s policy for income sharing for inventions covered under the Policy on Inventions, Patents, and Technology Transfer. Accordingly, as provided in Section V, Duke data that are licensed in connection with certain out-licensed IP, such as
patents or algorithms, will not give rise to any additional revenue sharing under this policy.

II. Applicability

This policy shall apply to the Duke University and its Schools of Medicine and Nursing and to all of DUHS.

This policy applies to employees who are defined for purposes of this policy as all faculty, staff, and other persons receiving compensation from the University or DUHS for services rendered, as well as all research personnel, students and graduate assistants, whether compensated or not, who work on any research project under Duke control, and medical staff, whether compensated or not, who deliver clinical care in the context of DUHS (collectively “Covered Persons”).

This policy applies solely to data from human sources, including but not limited to DUHS patient records and data whose creation and use fall under the jurisdiction of research ethics committees (for example, the DUHS IRB and campus IRB). Human biospecimens, insofar as they retain any associated phenotypic data, are covered by this policy. This policy’s principles for determining data licensing transactions and for sharing income from such transactions do not apply to data that is not derived from human sources.

This policy is not intended to apply to the sharing of data derived from human sources if:

(i) those data are exchanged among Duke faculty and students solely for academic purposes,
(ii) those data shared through agreements negotiated by the Office of Research Contracts,
(iii) those data shared through Health Information Exchanges (NCHIE, NCHA, Federal eHealth Exchange, etc.); and
(iv) Data licensed through procurement arrangements in which a vendor providing a
good or service to Duke requires a license to the data as a condition of providing this good or service (e.g., IT operational contracts).4

4 Data sharing and/or data use rights granted beyond the specific good or service being provided on behalf of Duke are not excluded from this policy.

III. Administrative Responsibility

This policy will be jointly administered by (i) the Chancellor for Health Affairs at Duke University, President and Chief Executive Office of DUHS and (ii) the University Vice President for Research (the “Responsible Officials”). The Responsible Officials shall have all authority for making decisions under this policy, both with respect to entering into data licensing transactions and for sharing income when a Data Enhancer (as defined below) is identified.

In their sole discretion, the Responsible Officials may delegate administrative responsibilities to other offices, officers, committees or other bodies.

IV. Agreements

The policy as amended from time to time shall be deemed to be a condition of initial or continuing employment of every Duke employee and a condition of enrollment and attendance of every student who works on any research project under Duke control and a condition of participating in the medical staff, whether compensated or not, delivering clinical care in the context of DUHS. All data licensing activities occurring after the effective date of this policy shall be subject to this policy.

V. Appeals

Any party may appeal a decision under this policy to the President of the University or the President’s designee(s). Within ten business days after the President’s decision, any person aggrieved by the application of this policy may proceed as of right to binding arbitration before a single arbitrator pursuant to the commercial arbitration rules of the American Arbitration Association. Each party shall bear its own costs in connection with the proceedings; but in the event an Arbitrator finds that a party has proceeded in bad faith, the Arbitrator may award costs and expenses (including attorneys’ fees) to the other party.

VI. Termination or Revision of Policy

This policy may be changed or discontinued at any time by action of the Board of Trustees. Such changes or discontinuance shall not affect rights accrued prior to the date of such action.

Data Licensing Policy FAQs

1. What types of data are covered under this policy?

 This policy applies solely to data from human sources and biospecimens to the extent they retain associated phenotypic data. This includes, but is not limited to, DUHS patient records/clinical information and data whose creation and use fall under the jurisdiction of research ethics committees (for example, the DUHS IRB and campus IRB).  This policy does not apply to data that is not derived from human sources.

2. Does this policy cover all Duke Units?

Yes, the Policy includes Duke University, its Schools of Medicine and Nursing, and DUHS, which includes DUHS’ affiliates such as the Duke PRMO, LLC, the Duke Integrated Network, Inc., and the Duke University Affiliated Physicians (Duke Primary Care).

3. What is a “Covered Person?”

All faculty, staff, and other persons receiving compensation from the University or DUHS for services rendered, as well as all research personnel, students and graduate assistants, whether compensated or not, who work on any research project under Duke control, and medical staff, whether compensated or not, who deliver clinical care in the context of DUHS are covered by this Policy and are, therefore “Covered Persons.”

4. How does the policy relate to other existing Policies regarding IP, revenue sharing, etc.?

This policy does not alter or amend the ownership interests that Duke or other persons have in data under other applicable policies, including the Duke University Policy on Intellectual Property Rights and the Policy on Research Records: Sharing, Retention, and Ownership. Nor does this policy alter or amend Duke’s policy for income sharing for inventions covered under the Policy on Inventions, Patents, and Technology Transfer.

5. What if the human source data is identifiable?

Identifiable human source data should not be shared or licensed outside of Duke without first reviewing the request with ORC. All licensed human source data must be de-identified, specifically, removal of the 18 identifiers, in accordance with the Health Insurance Portability and Accountability Act (HIPAA) Safe Harbor (DUHS De-Identified Protected Health Information Policy) or configured as a limited data set in accordance with HIPAA (DUHS Uses and Disclosures Involving Limited Data Sets Policy).

6. Do I own the human source data collected by my laboratory?

Pursuant to Duke’s Policy on Research Records: Sharing, Retention, and Ownership, the primary owner of all research records is the University. Research records include, by way of example but not limitation, material contained in research notes, laboratory notebooks, and in other media such as computer disks and instrument printouts.

Significant research materials or products generated by any research are also part of the research record.

7. Who is a “Data Enhancer?”

A Duke employee who contributes individually identifiable creativity, ingenuity, and intellectual effort to the data collection or curation that gives the data its licensable value. However, if your daily job requires the application of these qualities you may not be a Data Enhancer.

8. What about the clinician/faculty member who were PI’s on the clinical trial?

Generally, clinicians or faculty members who collect clinical trial data in the routine delivery of clinical care or as part of their daily job responsibilities will not be considered a Data Enhancer, unless the individual makes a significant creative and intellectual contribution to the data that gives it its licensable value.

For example, if the clinical trial is Investigator-initiated and is determined to include individually identifiable creativity, ingenuity and intellectual effort to the data collection or curation (beyond the protocol) that gives the data its licensable value; a Covered Person who meets this standard would be considered a Data Enhancer.

9.  Who decides who is a Data Enhancer?

The Data Licensing Committee will conduct its own diligence as to whether an individual will be considered a Data Enhancer and, if so, whether other Duke community members also meet the standard. This diligence may include interviewing individuals involved in the collection and compilation of the data.

10. What are examples where there would not be a Data Enhancer?

Data created, collected and/or stored in the standard operations of Duke, including, for example, the routine delivery of clinical care; or, Data to which ingenuity and creativity have been applied, but the Duke role or job position specifically requires the application of such qualities to the daily work of the Duke faculty and staff member.

11. What if human source data is included in a license agreement that also includes patents, for example, regulatory data from an IND, data in support of the patent application, etc.

Income resulting from licenses where data are included or contemplated as part of an intellectual property license will be shared according to the Policy on Inventions, Patents, and Technology Transfer and no additional income share will be given under this policy.

12. Can Duke sell human source data?

No, Duke does not sell human source data. In certain circumstances, Duke may license human data to third parties. Human source data licensed in this matter must either be de-identified or configured as a limited data set and may be licensed pursuant to a HIPAA permitted purpose.

13. Who makes the decision on licensing human source data? What if I do not want to license human source data from my repository, laboratory, or clinical study to a for-profit third party?

Generally, faculty contact the Office of Translation & Commercialization directly to begin the process of licensing human data. If you have human source data that has licensable value, however, the University may decide to license that human data without your approval, after review of your concerns with the Data Licensing Committee.

14.  Who makes the decision on what to charge a third party for the human source data?

Generally, the Office of Translation & Commercialization, in consultation with the Data Licensing Committee, will determine the financial terms of the data licensing agreement. These may be determined using benchmarks from prior agreements, determination of the costs for reproducing such data, and other inputs.

15.  What if I want to share human source data with a colleague at Duke or at another academic or non-profit institution?

Sharing of human source data among colleagues at Duke in accordance with Duke policies is permitted and encouraged. Clinical data, including EHR data, must be maintained within approved Duke Health computing environment. Please contact Duke Health ACE with any questions or requests for access to clinical data.

Sharing of human source data outside of Duke with academic colleagues for research purposes is also encouraged, but should be managed under Duke Health and HIPAA compliance procedures. Generally, an appropriate agreement will be negotiated by the Office of Research Contracts.

16. What if the human source data are to be used by a vendor developing products to be used by Duke?

Typically, these agreements are managed by DU procurement. If you have questions, please contact Dean Freck in the University Procurement Office.

17. What if I want to release human source data to a public database for future non-Duke and Duke research purposes (Research) or clinical purposes including, but not limited to, establishing quality metrics and/or benchmarking patient outcomes and clinical effectiveness (i.e. quality improvement)(Clinical Registries)? 

Please contact the following:

18. Can human source data be licensed to a company in which I hold equity?

Potentially yes, but the license would need to be reviewed by the Data Licensing Committee. Duke’s Office of Scientific Integrity (DOSI) is represented on the Data Licensing Committee. DOSI would address potential conflict of interest concerns, including creation of any applicable conflict of interest management plan.

19. Can human source data be licensed to a company sponsoring research in my laboratory?

Yes, either under the terms of your sponsored research agreement negotiated by a SOM central administration office (most likely Office of Research Contracts) or under a license negotiated by the Office of Translation & Commercialization. However, it is unlikely you would be considered a Data Enhancer in this situation.

20. Can human source data be licensed exclusively to a company?

Duke’s strong preference is that human source data is de-identified or configured as limited data set, as such terms are defined by HIPAA, and licensed non-exclusively and without the right to sublicense or to provide the data to another third party. The Data Licensing Committee will review special circumstances and determine exemption.

21. Who shares in the revenues from licensing of human source data?

If a Data Enhancer is identified, Net Revenue shall be shared as follows: 30% to the Data Enhancer; and remaining apportioned among Duke entities.

If there is no Data Enhancer, Net Revenue is apportioned among Duke entities.

22. What if I don’t agree with the decisions about my being a Data Enhancer or the revenue sharing distribution?

If an individual does not agree with a decision pursuant to this Data Licensing policy, the individual may request to attend the Data Licensing Committee to discuss the decision. The individual may subsequently review the decision with the Chancellor for Health Affairs and/or University Vice President of Research.  If the individual does not agree with the reviews, such individual may appeal a decision to the President of the University or the President’s designee(s). Within ten business days after the President’s decision, any person aggrieved by the application of this policy may proceed as of right to binding arbitration before a single arbitrator pursuant to the commercial arbitration rules of the American Arbitration Association. Each party shall bear its own costs in connection with the proceedings; but in the event, an Arbitrator finds that a party has proceeded in bad faith, the Arbitrator may award costs and expenses (including attorneys’ fees) to the other party.

23.  What if a sponsor is paying for collection of the human source data under either a clinical trial agreement or other sponsored research agreement?

In cases where a sponsor is paying for the collection of human data, it is unlikely you would be considered a Data Enhancer. Those agreements would be handled by the Office of Research Contracts. Contact: Susan Hayden, J.D., Office of Research Contracts

For additional questions, please contact docr.help@dm.duke.edu.