Data Licensing

What Qualifies as Data?

Data at U-M can be generated in many ways in the course of research, among others.  

Here are some examples: 

• Information about a person’s response to new therapeutic drugs
• A database of scanned images of materials exposed to radiation 
• Readings from a series of water level meters throughout a watershed. 
• Results from an externally administered questionnaire about attitudes towards social issues. 

Whether data qualifies as human data under applicable laws or regulations is an important threshold issue in assessing the best path for data access.

Data Stewardship

Pursuant to applicable U-M guidelines, research data generated by people employed by U-M and using U-M resources is a U-M asset. The U-M guidelines can be found here: FAQ: Guidelines for Access to and Use of Research Data

In some cases, sponsored research agreements or other contracts may place requirements on the use of data. In consultation with the researcher, Innovation Partnerships can work to develop a commercialization and access plan for valuable data sets to address appropriate research community participation and economic interests.

Regulatory Landscape

The flexibility with which data may be licensed also depends on the extent that it is regulated. Potentially applicable laws and regulations include HIPAA, the Common Rule, FERPA, GDPR, and many others. In order to assess applicable regulations, the following information is relevant: 

• What is the source of the data?
• What types of identifiers are included in the data?
• Where was the data collected and where will it be used?
• Are there any permissions required from the people who provided the data? 
• Is the data export controlled?

Data Sharing at U-M

Typically, human data for research purposes is shared in the following ways: 

• Directly or indirectly identifiable clinical data is shared via an appropriate compliance office
• Research data and de-identified clinical data is shared via the Office of Research and Sponsored Projects (ORSP)

When individual participant or patient level data from Michigan Medicine is transferred, it may be reviewed by the Medical School Human Data and Biospecimens Release Committee pursuant to applicable policy. 

For anonymous Human Data and all other Non-human Data, data is shared in the following ways:

• If the data is being shared via NDA to research or industry partners, you will work with the Office of Research and Sponsored Programs (ORSP) or Innovation Partnerships 
• If the data is being shared via a license, you can get help from Innovation Partnerships or ORSP 
• If the data is being shared publicly using, for example, the Creative Commons license, you can work with Deep Blue Data, the individual Units or on your own.

Models For Success

There are a number of factors to think about when considering making data available to for-profit companies.  

• Value: Sometimes the value of the data stands by itself. Other times, the data is most valuable when combined with other data sources. Additionally, it may be part of a broader offering. For example, access to data is often granted as part of a consortium membership where members receive licenses to applicable patent rights and gain access to students and faculty. 
• Access: There are a number of decisions about how to control access to data in order to preserve research freedom or to abide by contractual or legal obligations. For example, you may want to require login or in person access to the data. 
• Costs: Making data available in a usable form is not without curation and hosting costs. Recovering those costs may be an important reason to consider licensing data to for-profit companies. 

Working with the team at Innovation Partnerships, we can come up with the right model that fits your requirements.

Data Licensing Process

Please file a disclosure with Innovation Partnerships in the following circumstances: 

• If you intend to charge a fee
• If you intend to allow the recipient to use the data beyond a particular research project
• If you believe your data could have value to a company in developing or delivering a product or service to address a need in the world.

The process to receive support from Innovation Partnerships for data is similar to that of other innovations: 

1. Contact Innovation Partnerships and submit a disclosure to the office.
   Submit Your Innovation
2. We will review U-M’s rights in the data, identify the “inventors” under U-M policy, and confirm U-M’s freedom to transfer the data under any funding or regulatory restrictions.
3. Obtain approval from relevant central internal review bodies (if any).
4. Working together with you, we will define the goals of making the data available, assess valuation/pricing, and formulate a supporting plan including how to make the data available. 
5. Execute external licensing plan: Identify and contact potential licensees, negotiate and close licenses, and transfer the data. 

Frequently Asked Questions

Do researchers own their data? 

Data created by U-M employees is governed by University guidelines as described here: FAQ: Guidelines for Access to and Use of Research Data

What are the issues of sharing data with collaborators at other institutions? 

If your data is regulated, data sharing will be controlled via a central campus office. If it is unregulated, your Unit may control dissemination or, if it is confidential or valuable, it may be shared via NDA.

I am moving to another institution; can I take my data with me?

Usually yes, although there is likely the need to have a contract in place between the two institutions which may restrict the use to a specific project or time period. 

Can I make data available for commercial entities? Does that violate my ethical duties or open access duties?

Some federal awards require depositing data into repositories. Provided other regulatory, contractual, and university requirements are met, industry licensing can be harmonized with open access or government duties especially in cases where there is tiered pricing. 

Does granting an exclusive license to data to a company prevent me from using the data for research? 

No, U-M, as a general rule, retains the right to use any licensed IP or data for academic research.