Margaret Talbot has written an excellent New Yorker essay entitled, “The Rogue Experimenters,” which documents the growth of the D.I.Y.-bio movement. This refers to the organic, bottom-up, citizen science movement, or “leaderless do-ocracy” of tinkerers, as she notes. I highly recommend you check it out.

As I noted in my new book on Evasive Entrepreneurs and the Future of Governance, “DIY health services and medical devices are on the rise thanks to the combined power of open-source software, 3D printers, cloud computing, and digital platforms that allow information sharing between individuals with specific health needs. Average citizens are using these new technologies to modify their bodies and abilities, often beyond the confines of the law.”

Talbot discusses many of the same examples I discuss in my book, including:

• the Four Thieves Vinegar collective, which devised instructions for building its own version of the EpiPen;
• e-nable, an international collective of thirty thousand volunteers, designs and 3-D-prints prosthetic hands and arms (and which has, more recently, distributed more than fifty thousand face shields in more than twenty-five countries.);
• GenSpace and other community biohacking labs; and
• Open Insulin and Open Artificial Pancreas System.

I like the way Talbot compares these movements to the hacker and start-up culture of the Digital Revolution:

The D.I.Y.-bio movement, which emerged in the early two-thousands, seems almost evolutionarily adapted to its historical moment,” she argues. “It echoes aspects of startup culture, especially the early days of personal computing, with its garage-based origin stories. First came the hardware, then the software; now even the wetware of life can be created in people’s homes. D.I.Y. bio reflects popular skepticism about professional authority and gatekeeping, but it is not skeptical about learning or expertise.

She also quotes others on this point, like John Wilbanks, a health technologist at the research nonprofit Sage Bionetworks:

when new biotech companies fail, they tend to sell off their equipment for a discount, and community labs and biohackers scoop it up. Wilbanks told me, “D.I.Y. bio is very similar to the home-brew, hacker-club culture of the late seventies in Silicon Valley. If you’ve not gone on eBay to shop for a DNA sequencer that they can ship to you in twenty-four hours, check it out—there’s a massive secondary market.”

Perhaps the most interesting thing about this bottom-up citizen-science movement is that it run the political gamut. It includes “anarcho-libertarians” to those “steeped in social-justice activism,” Talbot says. But they are all generally unified by a commitment to the widespread dissemination of scientific knowledge and transparency in health-related matters. “D.I.Y. biologists often have a greater commitment than their professional counterparts do to making their work open to scrutiny—and available for free on the Internet,” Talbot notes.

“The D.I.Y.-bio ecosystem includes a lot of do-gooders, and many of them have been galvanized by the covid-19 crisis,” she also observes. Quite right. I discussed that fact in the launch essay for my book, “Evasive Entrepreneurialism and Technological Civil Disobedience in the Midst of a Pandemic.” I documented dozens of examples of various individuals and organizations rising up to meet the challenges posed by the pandemic. “Eventually, people take notice of how regulators and their rules encumber entrepreneurial activities, and they act to evade them when public welfare is undermined,” I argued. “Working around the system becomes inevitable when the permission society becomes so completely dysfunctional and counterproductive.” DIY health innovation has gone mainstream out of necessity.

Importantly, Talbot notes that when it comes to what counts as success for DIY health and biohacking, sometimes good enough is, well, good enough. On this point, she quotes Jon Schull, an e-nable (non-commercial 3D-printed prosthetics) co-founder, who says, “it doesn’t matter that e-nable hands aren’t state-of-the-art. The job of professional prostheses-makers, he said, is “to produce something really good, and if it’s merely better than nothing it’s not good enough”—but, in some circumstances, something is better than nothing.”

That is a crucial point understanding why this movement is so important: Working together in a spontaneous, bottom-up fashion, citizen scientists and tinkerers can act quickly to fill pressing public health needs. Of course, that is exactly what makes these same innovations potentially risky and has some people wondering about the wisdom of such efforts—and the potential need for more regulation.

I wish Talbott would have spent a bit more time diving into these ethical and legal questions. I really struggled with them when writing about all this stuff in my new book on evasive entrepreneurialism and technological civil disobedience. She does briefly discuss how some FDA regs might affect DIY bio movement, including efforts like Open Insulin.  “Even if Open Insulin begins producing a consistent product, it will have to overcome all kinds of regulatory obstacles to demonstrate safety and purity before taking it to market,” she notes. “Manufacturers of pharmacy-grade medications must provide the F.D.A. with reams of evidence that they can produce the substances with complete consistency, in sterile environments. Proving this level of proficiency can cost millions of dollars.” But Talbot does not spend much more time exploring what might happen next on this front if DIY efforts continue to expand.

“But what should the law say about people… who are creating their own specialized medical devices in an open-source, noncommercial fashion?” I ask in my new book.

I outlined three potential future scenarios for the movement:

1. DIY technologies go mainstream and become more commercialized.
2. biohacking remains decentralized but becomes more mainstream and professional without becoming fully commercial.
3. biohacking turn even more rogue or underground in nature as a form of guerrilla innovation that sometimes borders on neo-anarchism.

Regardless of the outcome, the ethical and regulatory issues will persist and grow as technological capabilities continue to grow more sophisticated, decentralized, and inexpensive. I argue in the book that it would be foolish for policymakers to think they can (or should) bottle up this movement altogether:

biohacking and decentralized medicine will expand for a simple reason: People care deeply about improving their health and abilities. They will take advantage of new technological capabilities that let them do so—especially when those capabilities are significantly cheaper than other options. To reiterate, that does not make these technologies safe or smart, but it does mean we will need a new approach to governance as evasive entrepreneurialism expands in this arena.

And then I continue on to note how improved risk education and awareness efforts might be one solution to the growing DIY bio movement.

Anyway, for more discussion on this, see pages 79-87 of my new book. I’ve also listed a few other essays down below that you might find interesting, including several penned by my former colleague Jordan Reimschisel.

Additional Reading:

• Andrea O’Sullivan & Adam Thierer, “3D Printers, Evasive Entrepreneurs and the Future of Tech Regulation,” The Bridge, August 1, 2018, https://www.mercatus.org/bridge/commentary/3d-printers-evasive-entrepreneurs-and-future-tech-regulation
• Jordan Reimschisel, “Biohackerspaces,” Medium, June 29, 2017, https://medium.com/@jordanreimschisel/biohackerspaces-b0cbde63c492
• Jordan Reimschisel, “Technology Could Enable Personal Medicine Whether We Like It Or Not,” Medium, August 10, 2017, https://medium.com/@jordanreimschisel/technology-could-enable-personal-medicine-whether-we-like-it-or-not-ce6e19b826fe
• Jordan Reimschisel, “Evolving Oversight of Digital Health,” Medium, June 21, 2018, https://medium.com/@jordanreimschisel/evolving-oversight-of-digital-health-d65199913503
• Adam D. Thierer and Adam Marcus, “Guns, Limbs, and Toys: What Future for 3D Printing?” Minnesota Journal of Law, Science & Technology, Vol. 17, No. 2, (2016), p. 805-854, http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2795562

Adam Thierer & I have just released a detailed examination (PDF) of brewing efforts to expand the Children’s Online Privacy Protection Act of 1998 to cover adolescents and potentially all social networking sites—an approach we call “COPPA 2.0.”

As Adam explained on Larry Magid’s CNET podcast, COPPA mandates certain online privacy protections for children under 13, most importantly that websites obtain the “verifiable consent” of a child’s parent before collecting personal information about that child or giving that child access to interactive functionality that might allow the child to share their personal information with others. The law was intended primarily to “enhance parental involvement in a child’s online activities” as a means of protecting the online privacy and safety of children.

Yet advocates of expanding COPPA—or “COPPA 2.0″—see COPPA’s verifiable parental consent framework as a means for imposing broad regulatory mandates in the name of online child safety and concerns about social networking, cyber-harassment, etc. Two COPPA 2.0 bills are currently pending in New Jersey and Illinois. The accelerated review of COPPA to be conducted by the FTC next year (five years ahead of schedule) is likely to bring to Washington serious talk of expanding COPPA—even though Congress clearly rejected covering adolescents age 13-16 when COPPA was first proposed back in 1998.

We’ll discuss some of the key points of our paper in a series of blog posts, but here are the top nine reasons for rejecting COPPA 2.0, in that such an approach would:

• Burden the free speech rights of adults by imposing age verification mandates on many sites used by adults, thus restricting anonymous speech and essentially converging—in terms of practical consequences—with the unconstitutional Children’s Online Protection Act (COPA), another 1998 law sometimes confused with COPPA;
• Burden the free speech rights of adolescents to speak freely on—or gather information from—legal and socially beneficial websites;
• Hamper routine and socially beneficial communication between adolescents and adults;
• Reduce, rather than enhance, the privacy of adolescents, parents and other adults because of the massive volume of personal information that would have to be collected about users for authentication purposes (likely including credit card data);

• Would likely be the subject of massive fraud or evasion since it is not always possible to definitively verify the parent-child relationship, or because the system could be “gamed” in other ways by determined adolescents;
• Do nothing to prevent offshore sites and services from operating outside these rules;
• Present major practical challenges for law enforcement officials in the face of such evasion by both domestic users and offshore sites;
• Could destroy opportunities for new or smaller website operators to break into the market and offer competing services and innovations, thus contributing to consolidation of online content and services by erecting barriers to entry; and
• Violate the Commerce Clause of the U.S. Constitution, since Internet activity clearly represents interstate commerce that states have no authority to regulate.