This post originally appeared on the Shapeways blog.

Jane Park at the Creative Commons Global Summit 2017 by Sebastiaan ter Burg CC BY 2.0

The relationship between Creative Commons and the 3D design community is deep and complicated. Last month’s Creative Commons Summit in Toronto provided an opportunity to celebrate the depth and … work on the complications.

Creative Commons was originally conceived with traditional copyright-eligible works like photographs, music, and books in mind, assuming that the works licensed by a Creative Commons (CC) license would clearly be eligible for copyright.  The 3D printing design community has integrated CC licenses from its early days, even though copyright does not always apply as cleanly to 3D designs. This organic and somewhat unexpected pairing has lead to a vibrant culture of sharing and collaboration in the 3D design community. It has also raised a number of surprisingly thorny copyright questions.

Fortunately, at least one proposal presented at the Summit would address some of those questions. We’ll outline the proposal in part two of this post, which can be found here.

How We Got Here

Creative Commons has been part of the 3D printing community for years. Thingiverse’s decision to build Creative Commons licenses into the bones of the site helped bring — and sometimes push — countless designers into a sharing community. It also established sharing as an important norm in the 3D design community.

Like 3D printing itself, copyright and 3D printing don’t always align perfectly. Image: Tony Buser CC BY-SA 2.0.

While the ethos of Creative Commons is in close alignment with the beliefs of many 3D designers, the legal realities do not always fit together as cleanly. Creative Commons is a copyright license, but not all 3D printed objects are eligible for copyright protection. That means that a Creative Commons license might not work as expected when it is attached to some 3D printable designs because it might not actually be legally enforceable. Furthermore, conditions that are easy to apply in a digital world (like attribution) can be somewhat harder in the physical realm.

In 2015, Creative Commons held the first formal explorations of the relationship between 3D printing and CC at its Summit in Seoul. That exploration established the foundation for a more detailed discussion last year. With Jane Park and Sarah Pearson guiding the analysis, last year’s discussion helped frame some of the questions that we attempted to answer at this year’s Summit.

3D Printing and Copyright Have a Complicated Relationship

This blog post would be a simple story of two great communities working together except for one challenge: copyright does not apply cleanly in the world of 3D printing. As a result, in the context of 3D printing, licenses based on copyright (such as CC licenses) are not always what they appear. (Pages 4-12 of this white paper explore when copyright does and does not attach to 3D printed files and objects.)

The traffic light on the left creates a legally enforceable obligation to stop at the intersection. The traffic light on the right can only send a social signal to stop doing whatever it is you are doing. Credits: Left image grendelkhan CC BY-SA 2.0. Right image Becky Stern CC BY-SA 2.0. Combined image offered under CC BY-SA 2.0.

Sometimes they exist as legally enforceable licenses. Other times they are merely social signals, requesting that users follow rules that cannot be enforced in court. Oftentimes designers and users are not clear which of those roles apply to any specific model being licensed.

This complicated relationship can create at least two categories of problems if a creator adds a CC license (for example, a CC BY-SA license that requires users to give attribution to the creator and to relicense any adaptations under a similarly open terms) to a model that is not protected by copyright.

Category 1: Damned if you do

First, applying a CC license to a work not protected by copyright shrinks the commons.

By default, a work that is not protected by copyright is in the public domain, available for anyone to do whatever they want with it. No license is required – that’s what the public domain means.

Even if they are not legally enforceable, CC conditions can create barriers to use. Credit: Teresa Alexander-Arab CC BY-ND 2.0.

But some users who want to make use of the public domain model may be prevented from doing so because they do not want to have to comply with the share-alike requirements of the license incorrectly applied to it. Fortunately, since the model is not protected by copyright, that share-alike requirement is not legally enforceable. It is a request masquerading as a demand. Unfortunately, that masquerade may be convincing enough to scare some users away from making completely legitimate uses of the work.

Second, incorrectly using a license can disillusion creators.

This happens when the creator incorrectly believes that the licenses are enforceable for works that are not protected by copyright. A creator could use a CC license to release models online for years. Only after trying to enforce the license would they discover that the condition of attribution baked into that license is unenforceable.

Category 2: Damned if you don’t

Unfortunately, there is also danger in omitting a license when a designer believes that the work is not protected by copyright at all.

If the designer is wrong and the design (or part of the design) is actually protected by copyright, the lack of a CC license will prevent future users from building upon it. This mistake is easier to make than it might appear.  Sometimes only small, easily overlooked, parts of models are protected by copyright. Other times copyright law evolves, extending protection to works that were in the public domain when they were created. That means that a creator could be correct about the copyright status of the work when it is created, but wrong by the time a user comes along looking to use it.

Like I said, complicated.

Summit Goals

While Creative Commons ultimately decides how (if at all) it wants to engage with these complicated questions as an organization, the purpose of the sessions at the Summit was to define factors to consider and possibly propose options. Presentations by re:3D, MakerBot (as home to Thingiverse), Aleph Objects, the NIH 3D Print Exchange, and Creative Commons US helped describe current community expectations and propose possible paths forward.

These presentations, especially the one by CC USA’s Meredith Jacob, helped to flag a number of considerations that the community and CC need to keep in mind when trying to address the concerns that prompted the session.

Licenses First, Social Signals Second

Judges need to be able to enforce CC licenses as legally binding documents. Credit: Dark Dwarf CC BY-ND 2.0

CC licenses serve a legal purpose (as a binding legal agreement) and a social purpose (as a social signal to users about how a creator intends for a work to be used). Both of these purposes are important, although they can sometimes work to undermine each other. The key to the long term viability of Creative Commons is to make sure that the social use does not undermine the enforceability of the legal one.

If CC licenses become mere social signals, the legal foundation of Creative Commons begins to erode. That is because courts could decide that creators did not really mean to make their social signal legally enforceable, or that users cannot reasonably be expected to understand that they entered into a real, legally binding agreement when they used a work that was CC-licensed.

That makes it important to ensure that in most cases CC licenses are used in ways that are legally enforceable — as licenses for copyrights that actually exist. Encouraging people to put CC licenses on every 3D printable thing would result in many CC licenses being used in works that are not eligible for copyright protection. In other words, it would result in many CC licenses being used only as social signals.  Use primarily as a social signal undermines the enforceability of CC licenses because it undermines the argument that CC licenses are intended to be legally enforceable promises.

Growing the Commons vs. Empowering Sharers

You need to be able to find things in the commons in order to use them. Credit: Paul Keller CC BY 2.0

There is a distinction between a legal commons and a findable commons. The legal commons is made up of works in the public domain (i.e. works not protected by copyright) and works that are permissively licensed with Creative Commons licenses. These are all works that are legally available for people to remix, build upon, and improve without risk.

The findable commons is a smaller subset of the legal commons. It includes works that can legally be shared and found by people who want to remix, build upon, and improve them. The mechanical door opener in your basement or the Renaissance painting in your attic may be part of the legal commons because they are not protected by copyright. But they are not part of the findable commons because other people do not know that they exist.

Convincing people to contribute works already in the legal commons to the findable commons is not a legal challenge. It is a social challenge. It involves making potential contributors comfortable with the idea of contributing to a collective pool of works available to everyone.

The Creative Commons licenses manage to grow the legal commons through the terms of the licenses and to grow the findable commons by allowing people to retain some control over their works. This partial control allows someone to ease into the idea of sharing without having to choose between being fully open or fully closed. Someone who is uncomfortable with the idea of unconditionally contributing their work to the commons might feel more comfortable contributing under the condition that any future users give them credit or that their work is not modified.

This can be true even for people creating works that are in the public domain (and therefore the legal commons) from the start. If they do not realize that the CC license cannot be enforced, the CC license terms may still encourage them to contribute their work that is in the legal commons into the findable commons by creating an illusion of control.

This creates a tension. Educating and empowering users so they understand when a CC license is not enforceable (and therefore drawing attention to the illusion) could also make them less reluctant to contribute to the findable commons. The win for user education could create at least a short-term loss for the commons. While user education is likely the higher good, it is important to recognize the potential short-term cost of its expansion.

Education Helps

At the core of all of these questions is the issue of education. There are 3D printable works that are protected by copyright. There are 3D printable works that are not protected by copyright. If designers and users could learn how to easily distinguish between the two and apply licenses in a legally accurate manner everything would be easy and this blog post would be a lot shorter.

Unfortunately, drawing this distinction can be complicated for specialists (and the U.S. Supreme Court keeps changing the rules). That makes it unreasonable to expect nonspecialists to fully understand the scope of copyright protection and unrealistic to think that we can educate our way out of this problem.

That being said, a better understanding of these issues could go a long way. Creative Commons may be well positioned to help create tools, disclaimers, and other mechanisms to help designers, platforms, and users understand what happens to the Creative Commons licenses as they drift further away from their traditional areas of coverage.

Part 2

So many questions and challenges!  Fortunately, part 2 of this blog post discusses a concrete proposal that helps address some of them.

This post originally appeared in Volume 56 of Make Magazine under the headline How to Know if the FDA Wants to Regulate  Your Prototype.  My contract required me to give them 3 months of exclusivity. With that up, I’m posting it here.

It’s all good fun to 3D print a DNA extraction centrifuge, make a homebrew heart rate monitor, or build an Arduino-powered bioreactor. But as you delve deeper into the world of biohacking, you may eventually wonder if (or when) the government will take an interest in what you’re doing.

There are lots of good reasons for government regulation here. When you take a drug, get a device implanted in you, or have a medical test done, it can be comforting to know that someone is ensuring that the drug isn’t poison, the device won’t explode inside you, and the medical test won’t insist that your ears are falling off (assuming that your ears aren’t actually falling off).

The Spirit of ‘76

For all of their benefits, regulations can also prevent good things from happening. Processes can be expensive to comply with and testing can take time. Small-scale participants can have trouble identifying rules relevant to them, let alone comply with them. That makes regulation, like so many things in life, a balance between safety and doing new things.

Unfortunately for DIY biohackers, the last time Congress passed a major medical device law was in 1976. Back then, only large companies had the ability to manufacture medical devices. Congress didn’t imagine that people would be making them at home. It certainly didn’t imagine that the at-home inventors would be able to distribute them to the world over the internet — and possibly do so without any commercial infrastructure.

Nonetheless, the regulatory structure of 1976 remains in force today. Devices are sorted into three tiers based on their intended use. Class I devices are regulated under “general controls,” which are generally light-touch rules designed to handle lower risk devices. Class II devices are subject to special controls because they are potentially more dangerous. Class III devices require premarket approval before being distributed. (We’re just setting the scene, but if you have specific questions about the three-tier system or about your specific device, you should speak with a lawyer.)

General Wellness vs. Medical

For our purposes, the question is not how medical devices are regulated, but rather when your project becomes a medical device that the FDA wants to regulate. The difference is between a “general wellness” device, which isn’t regulated, and a “medical” device, which is. Distinguishing between them involves two major factors.

The first is if the device is geared towards “general wellness.” The more the device is oriented towards general wellness, the less likely it is to be regulated by the FDA. General wellness is a focus on overall health instead of specific diseases. Think about jogging — it’s a healthy lifestyle choice that impacts a range of diseases, heart disease among them. But jogging isn’t a specific treatment for heart disease in the same way that prescription medication is. General wellness devices tend to measure things like fitness, sleep, concentration, heart rates, or physical impact in order to help you live a healthier lifestyle.

The second factor is whether the device poses a low risk to safety. Not surprisingly, if it doesn’t pose a safety risk, the FDA is more likely to classify it as a general wellness device. Conversely, if a device could pose a significant risk — even due to misuse — the FDA is likely to want to take a closer look. Helpfully, the FDA provides four characteristics to look for in a device, any one of which would suggest that the device poses a higher-than-low risk to safety:

• Is the product invasive (does it penetrate the skin)?
• Is the product implanted?
• Does the product use a technology that is itself risky if not regulated (think medical lasers or radioactive elements)?
• Are similar existing products regulated?

That last point is important. If you are working on a device and all of the established commercial devices in the space are regulated, the FDA will probably take a keen interest in your device as well.

What’s the takeaway here? Keep hacking and building new things. But as you start building devices that are geared toward treating specific diseases or that can do real harm if they malfunction, keep in mind that the FDA might be interested. At that point it is probably time to put down this magazine and find yourself a lawyer.

Learn More

The FDA recently published guidance to help distinguish between medical devices and wellness devices.

Anna Wexler takes a deep dive into the regulations surrounding brain stimulation devices currently on the market (there’s also a longer version that’s behind a paywall). Below is a presentation she gave on the topic:

The challenges posed by DIYers entering the modern medical space has not gone unnoticed by the medical establishment. Doctor Jeremy A. Greene outlines the various concerns with DIY medical devices in the New England Journal of Medicine.

The FDA itself walks through how it approaches some of these questions in section II. B. of this workshop paper on neurodiagnostic devices.

The FDA also provides information about how it regulates medical devices here, here, and here.

The National Gallery of Denmark. Image courtesy Jonas Heide Smith.

This post originally appeared on the Shapeways blog.

Today we are excited to announce a special jewelry contest in partnership with the National Gallery of Denmark. The contest gives the Shapeways design community a chance to have their jewelry displayed and sold in Copenhagen.

The National Gallery (known by its Danish initials, SMK) is a leader in the OpenGLAM movement. OpenGLAM promotes open access to cultural works in galleries, libraries, archives, and museums. SMK Open makes sure that works in SMK’s collection that are in the public domain (i.e., no longer protected by copyright) can easily be accessed and built upon by the public without restrictions.

The curators at SMK have selected six paintings in the public domain — including masterpieces by Cranach, Gijsbrechts, and Hammershøi — to serve as the inspiration for this contest. Designers can use these works as jumping-off points to create unique 3D printable jewelry. Since the works are not protected by copyright, designers are free to use whatever parts of the works they wish.

One winner and four runners-up will be displayed at SMK for the month of September 2017. These designs will also be eligible for sale in SMK’s gift shop. A panel of judges, including representatives from SMK and Shapeways, will select the winners.

All you need to do to enter is to design a new piece of jewelry based on one (or more than one) of the works, upload it to a public Shapeways shop, and tag it SMK.

But you had better hurry: The contest ends June 16, 2017.

To enter the contest, study the paintings, and read the complete rules, visit the SMK Collection Jewelry Design Contest page.

This post originally appeared on the Shapeways blog.

This week, Shapeways is proud to join over 800 of our fellow startups and tech companies in support of net neutrality. Our letter to the chairman of the U.S. Federal Communications Commisson, Ajit Pai, reiterates the importance of a fair, open internet to Shapeways and the entire Shapeways community.

This letter is necessary because Pai has indicated interest in rolling back the landmark open internet rules established by the FCC in 2015. Those rules formalized the protections that allowed for the growth of the internet that we know today.

Shapeways has long supported net neutrality because we understand how critical an open internet is to our success and to the success of every Shapeways user. Shapeways started as a small company in the Netherlands based on a technology that few people had heard of. We were in no position to cut deals and make special payments to big internet service providers just to be able to reach our customers. Net neutrality allowed us to grow as our community grew, not as gatekeeper internet service providers would let us grow.

The independent shop owners, makers, and creators that make up the Shapeways community rely on an open internet as well. They reach their fans, customers, and collaborators without having to worry about what the company that connects them to the internet thinks about their activity.

We hope that our letter will remind Pai of the importance of net neutrality and help convince him not to overturn these critical rules. We thank Engine, Techstars, and Y Combinator for helping to organize this letter, our colleagues for joining it, and all of the organizations and individuals who have fought — and will continue to fight — for an open internet. We understand that includes many members of our community, who we will keep you updated as this process continues to evolve.

This post originally appeared in the Shapeways blog.

Today, Shapeways joined with a number of other online platforms to submit a letter to the European Parliament. The letter raised our collective concerns about new online copyright proposals that the Parliament is currently considering. Specifically, we are concerned that a new proposal would erode or eliminate the safe harbors that allow online platforms like Shapeways to serve our users.

This proposal is in Article 13 of the proposed Digital Single Market Directive. As you may recall, online platforms such as Shapeways operate within what is known as a copyright safe harbor. That safe harbor allows us to trust that the content uploaded by our users does not violate anyone else’s copyright interest until and unless we hear from that anyone else. In the USA, this safe harbor is part of the Digital Millennium Copyright Act or DMCA (we’ve been talking about the DMCA in a slightly different context here, and you can learn how the DMCA process works in practice on Shapeways here). In the EU, it is part of the E-Commerce directive.

As originally written, the proposed Article could impose an obligation to create some sort of new copyright filtering technology, report the activity of our users to large rightsholders, and give large rightsholders control over what kinds of new services are created.

Fortunately, the EU policymaking process is a process, which means that the initial proposal is not necessarily the final version of the rule. Since the release of the original proposal, various committees have proposed changes and suggestions to the text.

While some of these proposals are improvements (for example, recognizing that users of online platforms are key stakeholders in the rules that govern online platforms), we are still skeptical that the changes are necessary at all. That is why we conclude our letter by urging policymakers to maintain the integrity of the safe harbors that have allowed so much creativity to flourish.

The Parliament now moves into a deeper discussion phase. We will continue to monitor the discussion, and provide updates as they become available.