Regulatory

Health in the Fast Lane: FDA’s Effort to Streamline Digital Health Technology Approval

October 7, 2017
FDA, Health, Regulatory, Uncategorized

Alex Eschenroeder, MJLST Staffer

The U.S. Food and Drug Administration (FDA) is testing out a fast-track approval program to see if it can accommodate the pace of innovation in the technology industry and encourage more ventures into the digital health technology space. Dr. Scott Gottlieb M.D., Commissioner of the FDA, announced the fast-track pilot program—officially named the “Pre-Cert for Software Pilot Program” (Program)—on July 27, 2017. Last week, the FDA announced the names of the nine companies it selected out of more than 100 applicants to participate in the Program. Companies that made it onto the participant list include tech giants such as Apple and Samsung, as well as Verily Life Sciences—a subsidiary of Alphabet, Inc. The FDA also listed smaller startups, indicating that it intends to learn from entities at various stages of development.

The FDA idea that attracted applicants from across the technology industry to the Program is roughly analogous to the TSA Pre-Check Program. With TSA Pre-Check certification, travelers at airports get exclusive access to less intensive pre-boarding security procedures because they submitted to an official background check (among other requirements) well before their trip. Here, the FDA Program completes extensive vetting of participating technology companies well before they bring a specific digital health technology product to market. As Dr. Gottlieb explained in the July Program announcement, “Our new, voluntary pilot program will enable us to develop a tailored approach toward this technology by looking first at the . . . developer, rather than primarily at the product (as we currently do for traditional medical products).” If the FDA determines through its review that a company meets necessary quality standards, it can pre-certify the company. A pre-certified company would then need to submit less information to the FDA “than is currently required before marketing a new digital health tool.” The FDA even proposed the possibility of a pre-certified company skipping pre-market review for certain products, as long as the company immediately started collecting post-market data for FDA to confirm safety and effectiveness.

While “digital health technology” does not have a simple definition, a recently announced Apple initiative illustrates what the term can mean and how the FDA Program could encourage its innovation. Specifically, Apple recently announced plans to undertake a Heart Study in collaboration with Stanford Medicine. Through this study, researchers will use “data from Apple Watch to identify irregular heart rhythms, including those from potentially serious heart conditions like atrial fibrillation.” Positive research results could encourage Apple, which “wants the Watch to be able to detect common heart conditions such as atrial fibrillation”, to move further into FDA regulated territory. Indeed, Apple has been working with the FDA, aside from the Program, to organize the Heart Study. This is a critical development, as Apple has intentionally limited Watch sensors to “fitness trackers and heart rate monitors” to avoid FDA regulation to date. If Apple receives pre-certification through the Program, it could issue updates to a sophisticated heart monitoring app or issue an entirely different diagnostic app with little or no FDA pre-market review. This dynamic would encourage Apple, and companies like it, to innovate in digital health technology and create increasingly sophisticated tools to protect consumer health.

The Future of AI in Self-Driving Vehicles

September 11, 2017
Autonomous Vehicles, Public Safety, Regulatory

Kevin Boyle, MJLST Staffer

Last week, artificial intelligence (AI) made a big splash in the news after Russian President Vladimir Putin and billionaire tech giant Elon Musk both commented on the subject. Putin stated that whoever becomes the leader in artificial intelligence (AI) will become “the ruler of the world.” Elon Musk followed up Putin’s comments by declaring that competition for AI superiority between nations will most likely be the cause of World War III. These bold predictions grabbed the headlines; but in the same week, Lyft announced a new partnership with a company that produces AI for self-driving cars and the House passed the SELF DRIVE Act. The Lyft deal and the House bill are positive signs for investors of the autonomous vehicle industries; however, the legal landscape remains uncertain. As Putin and Musk have predicted, AI is certain to have a major impact on our future, but current legal hurdles exist before AI’s applications in self-driving vehicles can reach its potential.

One of the legal hurdles that currently exists is the varying laws between state and federal authorities. For example, Companies such as Google and Ford would like to introduce cars with no pedals or steering wheels that are operated entirely by AI. However, most states still require that a human driver be able to take “active physical control” of the car to manually override the autonomous vehicle. This requires a steering wheel and brakes, which would make those cars illegal to operate. At the federal level, the FAA requires that commercial drones be flown by certified operators, not computers or AI. Requiring operators instead of AI to steer drones for deliveries severely limits the potential of this innovative technology. Furthermore, international treaties, including the Geneva Convention, need to be addressed before we see fully autonomous cars.

The bipartisan SELF DRIVE Act recently passed by the House attempts to address most of the issues created by the patchwork of local, state, and federal regulations so that AI in self-driving cars can reach its potential. The House bill proposed clear guidelines for car manufacture guidelines, clarified the role of the NHTSA in regulating automated driving systems, and detailed cybersecurity requirements for automated vehicles. The Senate, however, is drafting its own bill for the SELF DRIVE Act. This week, the Senate Commerce, Science, and Transportation Committee will convene a hearing on automated safety technology in self-driving vehicles and the potential impacts on the economy. The committee will hear testimony from car manufacturers, public interest groups, and labor unions. Some of these groups will inevitably lobby against this bill and self-driving technology for fear of the potentially devastating impact on jobs in some industries. But ideally, the Senate bill will stick to the fundamentals from the House bill, which focuses on prioritizing safety, strengthening cybersecurity, and promoting the continued innovation of AI in autonomous vehicles.

Several legal obstacles still exist that are preventing the implementation of AI in automated vehicles. Congress’ SELF DRIVE Act has the potential to be a step in the right direction. The Senate needs to maintain the basic elements of the bill passed in the House to help advance the use of the innovative AI technology in self-driving cars. Unlike Musk, Mark Zuckerberg has taken a stance similar to those in the auto industry, and believes AI will bring about countless “improvements in the quality of our lives,” especially in the application of AI in self-driving vehicles.

Say Goodbye to Net Neutrality: Why FCC Protection of the Open Internet Is Over

May 3, 2017
Internet, Regulatory

Kristin McGaver, MJLST Guest Blogger

[Editor’s Note: Ms. McGaver’s blog topic serves as a nice preview for two articles being published in this Spring’s Issue 18.2, one on the FCC generally by researchers Brent Skorup and Joe Kane, and one on the Open Internet Order more specifically by MJLST Staffer Paul Gaus.]

Net neutrality is a complex issue at the forefront of many current online regulation debates. In these debates, it is often unclear what the concept of “net neutrality” actually entails, what parties and actors it affects, and how many different approaches to its regulation exist. Nevertheless, Ajit Pai—newly appointed chairman of the United States Federal Communications Commission (“FCC”)—thinks, “the issue is pretty simple.” Pai is openly opposed to net neutrality and has publicly expressed his intent not to enforce current FCC regulations pertaining to the issue with his recently acquired position of power. This is troubling to many net neutrality supporters. Open Internet advocates are rightfully concerned that Pai will hinder recent success for the advancement and protection of net neutrality achieved under former President Obama, resulting in the FCC’s 2015 “Protecting and Promoting the Open Internet” Regulation. With Pai at the FCC helm, net neutrality policy in the United States (“US”) is noticeably in flux. Thus, even though official policies protecting net neutrality exist on the books, the circumstances surrounding their enforcement and longevity leave much gray area to be explored, chiseled out, and set into stone.

Net neutrality is the idea that all Internet traffic should be treated equally. Yet, since 2003 when Tim Wu coined the term, scholars and commentators cannot agree on a standard definition since that very definition is at the base of a multi-layered over-arching debate. In the US, the most recent FCC articulation of net neutrality is defined by three principles—“no blocking, no throttling and no paid prioriti[z]ation.” These principles mean that ISPs should not be allowed to charge companies or websites higher rates for speedier connections or charge the user higher amounts for specific services. The new “bright-line” rules forbid ISPs from restricting access, tampering with Internet traffic, or favoring certain kinds of traffic via the use of “fast lanes.” Markedly, one thing the 2015 Regulation did not completely forbid is “zero-rating” or “the practice of allowing customers to consume content from certain platforms without it counting towards their data plan cap”—a practice many see as violating net neutrality. Even with this and other exceptions, the 2015 Regulation’s passing was not met without resistance: Republican Senator Ted Cruz from Texas tweeted that the 2015 Regulation was “Obamacare for the Internet.”

Additionally, net neutrality supporters and the FCC majority did not have long to bask in their success after the 2015 Regulation’s approval. The United States Telecom Association and Alamo Broadband quickly challenged it in a lawsuit. Because the new regulation re-classified ISPs as common carriers and therefore subject to the FCC’s authority, Telecom claimed that the FCC was overreaching, harming businesses, and impeding innovation in the field. Fortunately for the FCC, the United States Court of Appeals for the District of Columbia upheld the 2015 Regulation in a 2–to–1 decision.

Yet, the waves are far from settling for the FCC and net neutrality supporters in the US. Following the D.C. Circuit’s 2016 decision, American company AT&T and other members of the cable and telecom industry signaled an intent to continue the challenge, potentially all the way to the Supreme Court. More importantly, the lead dissenter to the 2015 Regulation is now chairman of the FCC. In his first few months as Chairman, Ajit Pai declined to comment on whether the FCC plans to enforce the 2015 Regulation. Pai’s “no comment” does not look promising for net neutrality or for those hoping the US will maintain its intent to protect the open Internet as was articulated in the 2015 Regulation.

Although the 2015 Regulation remains on the books, the likelihood that it is carefully enforced, or really enforced at all, is pretty low. This leaves a total lack of accountability for breaching ISPs. Achieving a policy that is not entirely spineless is admittedly complicated in the context of an Internet that is constantly evolving and a market that is increasingly dominated by just a few ISPs. But, effective policies are not impossible, as evidenced by success in the European Union and several of their member states in setting policies that protect and promote net neutrality. It is clear from these examples that effective net neutrality regulation in the online context requires setting, maintaining, and enforcing official articulations of policy. However, with a clear signal from the FCC chairman to back away from the enforcement of a set policy, it will be as if no regulation exists at all.

What’s in That? the Dilemma of Artificial Flavor, Natural Flavor & Artificial Color

April 30, 2017
FDA, Food and Agriculture, Regulatory

Zach Berger, MJLST Executive Editor

By law, most food is required to display nutritional information; if a product bears nutrient content or health messages, it must comply with specific requirements. However, as questioned by J.C. Horvath in volume 13 of MJLST, do these requirements really help consumers? For example, how often do you see “contains artificial flavor” or something similar listed on your groceries? The use of the non-descriptive descriptor phrases such as “artificial flavor,” “natural flavor,” and ‘artificial color” are common on food labels, yet do not help the average consumer. These phrases can substitute for over 3900 different food additives. The difference between artificial and natural flavors is much more technical than meaningful as both contain chemicals. The distinction comes from the source of the chemicals. In reality, there is little difference between the two, as both are made in a laboratory by a trained professional, a “flavorist,” who blends appropriate chemicals together in the right proportions.

The Food and Drug Administration (FDA) does regulate these additives, but once a substance is Generally Recognized as Safe (GRAS) it may be added to anything without further testing for any unexpected chemical interactions with other ingredients. Examples of ingredients that fall under GRAS[1] range from beef tallow, lard, and gelatin to ambergris a “waxy substance generated in the digestive system of and regurgitated by sperm whales” and Lcystine, “a dough conditioner often derived from duck feathers or human hair.” Basically, these non-descriptive descriptors don’t tell the consumer anything useful, so companies allowed to use these stand-ins?

The Food industry is generally reluctant about releasing all of its ingredients in order to prevent competitors from easily replicating their product. However, “the information that would actually be useful to consumers tends to be categorical information. Things such as whether or not the product conflicts with dietary restrictions or contains artificial hormones or genetically engineered products. The goal of food labeling is clarity for the consumer and the use of the non-descriptive descriptor phrases are anything but clear; for the average consumer, they may as well not even be on the packaging. To make labeling more informative, Horvath recommended “FDA-mandated universal allergen warnings and front-of-pack labels to better educate consumers.” Whatever the solution is, it is time to end the use of non-descriptive descriptors.

[1] 21 C.F.R. 182.1–.99

What’s in That? the Dilemma of Artificial Flavor, Natural Flavor & Artificial Color

April 30, 2017
FDA, Food and Agriculture, Regulatory

Zach Berger, MJLST Executive Editor

[1] 21 C.F.R. 182.1–.99

Autonomous Weapon Systems: Legal Responsibility for the Terminator

April 19, 2017
International Law, Regulatory, Weapon Law

Ethan Konschuh, MJLST Staffer

While technological progress has been the hallmark of the twenty-first century, the rise has been especially drastic in weapons technology. As combatants in armed conflicts rely more and more heavily on automated systems pursuing such goals as safety, efficiency, and effectiveness on the battlefield, international law governing the use of force in armed conflicts is under threat of becoming outdated.

International law governing the application of force in conflicts is premised on notions of control. Humans have traditionally been the masters of their weapons: “A sword never kills anybody; it is a tool in a killer’s hand.” However, as automation in weapons increases, this relationship is becoming tenuous- so much so that some believe that there is not enough control to levy responsibility on anyone for the consequences of the use of these weapons. These actors are calling for a preemptive ban on this technology to avoid the possibility of the offloading of moral responsibility for war crimes. Others, however, believe that there are frameworks available that can prevent this gap in responsibility, and allow for the realization of the aforementioned benefits of using autonomous machines on the battlefield.

There are three general categories of policies proposed regarding the regulation of using these machines. One has been proposed by Human Rights Watch (HRW), International Committee for Robot Arms Control (ICRAC), the International Committee of the Red Cross (ICRC), and other NGO’s and humanitarian organizations have called for a preemptive ban on all autonomous weapons technology, believing that human input should be a pre-requisite for any targeting or attacking decision. The second regulatory regime has been espoused by, among others, the United Kingdom and Norther Ireland, who claim that there would be no military utility in employing autonomous weapon systems and agree they will never use them, effectively agreeing to a ban. However, the way that they define autonomous weapon systems belies their conviction. The definition put forth by these actors defines autonomous weapon systems in a way that effectively regulates nothing:

“The UK understands [an autonomous weapon system] to be one which is capable of understanding, interpreting and applying higher level intent and direction based on a precise understanding and appreciation of what a commander intends to do and why. From this understanding, as well as a sophisticated perception of its environment and the context in which it is operation, such a system would decide to take – or abort – appropriate actions to bring about a desired end state, without human oversight, although a human may still be present.”

This definition sets the threshold of autonomy so high that there is no technology that currently exists, or will likely ever exist, that would within its purview. The third policy framework was put forth by the United States Department of Defense. This policy regulates fully autonomous weapon systems (no human action connected to targeting or attacking decisions), semi-autonomous weapon systems (weapon depends on humans to determine the type and category of targets to be engaged), and human-supervised autonomous weapon systems (weapon can target and attack, but a human can intervene if necessary). This policy bans all fully autonomous weapon systems, but allows for weapons that can target and attack as long as there is human supervision, with the ability to intervene if necessary.

The debate surrounding how to regulate this type of weapons technology is continually gaining traction up in the face of advances approaching the threshold of autonomy. I believe the U.S. policy is the best available policy to prevent the responsibility gap while preserving the benefits of using automated weapons technology, but others disagree. Whichever policy is ultimately chosen, hopefully an international agreement is reached before it is too late, and your favorite sci-fi movies become all too realistic.

Why Equity-Based Crowdfunding Is Not Flourishing? — A Comparison Between the US and the UK

April 12, 2017
Financial Law, Internet, Regulatory, Securities Law

Tianxiang Zhou, MJLST Editor

While donation-based crowdfunding (giving money to enterprises or organizations they want to support) is flourishing on online platforms in the US, the equity-based crowdfunding (funding startup enterprises or organizations in return for equity) under the JOBS Act is still staggering as the requirements are proving impractical for most entrepreneurs.

Donation-based crowdfunding is dominating the major crowdfunding websites like Indiegogo, Kickstarter, etc. In March, 2017, Facebook announced that it will introduce a crowdfunding feature that will help users back causes such as education, medical needs, pet medical, crisis relief, personal emergencies and funerals. However, this new crowdfunding feature from Facebook has nothing to do with equity-based crowdfunding; it is only used for donation-based crowdfunding. As for the platforms specialized in crowdfunding, equity-based crowdfunding projects are difficult to find. If you visit Kickstarter or Indiegogo, most of the crowdfunding projects that appear on the webpages are donation-based crowdfunding project. As of April 2, 2017, there are only four active crowdfunding opportunities appearing on the Indiegogo website that are available for investors. The website stated that “more than 200 (equity-based) projects funded in the past.” (The writer cannot find an equity-based crowdfunding opportunity on Kickstarter or a section to search equity-based crowdfunding opportunities.)

The reason why equity-based crowdfunding is not flourishing is easily apparent. As one article points out, the statutory requirements for Crowdfunding under the JOBS Act “effectively weigh it down to the point of making the crowdfunding exemption utterly useless.” The problems associated with obtaining funding for small businesses that the JOBS Act aims to resolve are still there with crowdfunding: for example, the crowdfunding must be done through a registered broker-dealer and the issuer have to file various disclosure statement including financial statement and annual reports. For smaller businesses, the costs to prepare such reports could be heavily burdensome for the business at their early stage.

Compared to crowdfunding requirements in the US, the UK rules are much easier for issuers to comply with. Financial Conduct Authority (FCA) introduced a set of regulations for the peer-to-peer sector in 2014. Before this, the P2P sector did not fall under any regulatory regime. After 2014, the UK government requires platforms to be licensed or to have regulated activities managed by authorized parties. If an investor is deemed a “non-sophisticated” investor constraints are placed on how much they are permitted to invest, in that they must not invest more than 10% of their net investable assets in investments sold via what are called investment-based crowdfunding platforms. Though the rules require communication of the offers and the language and clarity of description used to describe these offers and the awareness of the risk associated with them, much fewer disclosure obligations are required for the issuers such as the filing requirements of annual reports and financial statement.

As a result, the crowdfunding market in the UK is characterized as “less by exchanges that resemble charity, gift giving, and retail, and more by those of financial market exchange” compared with the US. On the UK-based crowdfunding website Crowdcude, there are 14 opening opportunities for investors as of April 2, 17, and there were 494 projects funded. In comparison, the US-based crowdfunding giant Indiegogo’s statement that “more than 200 projects funded in the past” is not very impressive considering the difference between the sizes of the UK’s economy and the US’ economy.

While entrepreneurs in the US are facing many obstacles in funding through equity-based crowdfunding, the UK crowdfunding websites are now providing more equity-based opportunities to the investors, and sometimes even more effective than government-lead programs. The Crowd Data Center publicized a report stating that seed crowdfunding in the UK is more effective in delivering 40% more funding in 2016 than the UK government funded Startup Loans scheme.

As for the concern that the equity-based fraud funding involves too much risk for “unsophisticated investors,” articles pointed out that in countries like UK and Australia where lightly regulated equity crowdfunding platforms welcomed all investors, there is “hardly any instances of fraud.” While the equity-crowdfunding JOBS Act has not failed to prove its efficiency, state laws are devising more options for the issuers with restrictions of SEC Rule 147. (see more from 1000 Days Late & $1 Million Short: The Rise and Rise of Intrastate Equity Crowdfunding). At the same time, the FCA stated that it will also revisit the rules on crowdfunding. It would be interesting to see how the crowdfunding rules will evolve in the future.

MJLST for Kids: How the ESSA Promotes K-12 Edtech

April 9, 2017
Administrative Law, Education, Regulatory

Nolan Hudalla, MJLST Staffer

The Minnesota Journal of Law, Science, and Technology is frequently at the forefront of current technological advances. The journal’s publications often address the emerging systems and devices that are changing society, as well as the legal constructs that can be employed to optimize technology’s use. But the next generation is not yet old enough to read MJLST and understand its implications. So how are today’s young students empowered to learn about and keep pace with technology that is advancing so quickly? Additionally, how is such cutting-edge technology being provided to teachers to help them maximize student potential?

Federal funding for K-12 education is largely provided by the Every Student Succeeds Act (“ESSA”). The ESSA is a major education reform bill that was passed with bipartisan support in December 2015. It is the immediate successor to the highly controversial No Child Left Behind Act (“NCLB”), and there is great anticipation for the ESSA to finally take full effect in the 2017-2018 school year. In fact, Lamar Alexander, chairman of the Senate Health, Education, Labor and Pensions Committee, recently remarked that the new law “will unleash a flood of innovation and student achievement across America.” One specific way that the ESSA is trying to “unleash innovation” is through educational technology (“edtech”).

There are two primary ESSA-provided mechanisms that will impact K-12 edtech. First, Title IV of the ESSA authorizes the Student Support and Academic Enrichment Grant program. The program empowers states and districts to pursue their own edtech initiatives. Second, Title I – the nation’s largest source of federal funding to K-12 education – now makes it easier for schools to use existing funds for edtech than it was under the NCLB.

The Title IV grant program authorizes $1.65 billion dollars for states to dedicate to local priorities. Such priorities could include, for example, counseling, Advanced Placement classes, and edtech. Nearly $900 million of the grant program is permitted to go toward innovative edtech strategies, demonstrating Congress’s commitment to advancing technology in schools. In fact, this authorization is approximately 4 percent of the ESSA’s total funding provision.

Title I of the ESSA gives states and localities greater flexibility and control over the benchmarks that must be met to receive the Title’s funding. The NCLB was heavily criticized because it set rigorous federally-determined standards, with harsh penalties for districts and schools that could not meet those standards. The ESSA allows school districts to now have a say in what they must do to meet the Title I requirements. For example, a state could demonstrate that they are making satisfactory progress in their school districts, and thus qualify for Title I funding, in part by providing a district-chosen level of edtech programs each year.

In addition, Title I now permits states to reserve certain Title I funding for specific learning activities such as edtech. In particular, 3 percent of their Title I funds can go toward “Direct Student Services,” which could include individualized edtech curriculum in districts that particularly require improvement. The ESSA also provides funds for an Education Innovation and Research program that can be similarly leveraged.

Through the ESSA, the federal government has provided the opportunities and tools to significantly advance edtech. The bill authorizes a lot of money for the states to put toward advancing education initiatives through both grants and Title I funding provisions. However, it remains up to the states and localities to implement the necessary tools to fully take advantage of the new opportunities created by Congress.

The Excitement and Danger of Autonomous Vehicles

March 21, 2017
Autonomous Vehicles, Litigation, Regulatory

Tyler Hartney, MJLST Staffer

“Roads? Where we’re going we don’t need roads.”

Ok. Sorry Doc. Brown, but vehicular technology is not quite to where Back to the Future thought it would be in 2017; but, there are a substantial amount of companies making investments into autonomous vehicles. Ford invested $1 billion to acquire an artificial intelligence startup company that had been founded by engineers previously employed by Google and Uber with the intent to develop self-driving vehicles. Tesla already has an autopilot feature in all of its vehicles. Tesla includes a warning on its website that the use of the Self-Driving functionality maybe limited depending on regulations that vary by jurisdiction.

To grasp an understanding of what many of the experts are saying in this field, one must be familiar with the six levels of autonomy:

No autonomy
Driver assistance level – most functions still controlled by human driver
At least one driver assistance system – cruise control or lane monitoring
Critical safety features – shifts emergency safety features such as accident awareness from vehicle to human
Fully autonomous – designed for the vehicle to perform all critical safety features and monitor road and traffic conditions
Human like autonomy – fully capable of autonomy even in extreme environments such as off-road driving

The societal benefits could be vast. With level 4 autonomy on household vehicles, parents and siblings need not worry about driving the kids to soccer practice because the car is fully capable of doing it for them. Additionally, the ridesharing economy, which has grown incredibly fast over the past few years, would likely see a drastic shift away from human drivers. Companies have already begun to make vehicles for the purpose of clean energy ride sharing using autonomous vehicles such as Ollie. Ollie is an electric and 3D printed bus that can be summoned by those in need of a ride in a similar fashion to Uber.

While this self-driving vehicle technology is exciting, are we really there yet? Last June, a fatal car accident occurred involving a Tesla using its autopilot function. The driver in this case had previously touted his car saving him from an accident; he was very confident in the ability of his vehicle. It was later reported by a witness that there was a portable DVD player in the car that was found playing Harry Potter at the time of the accident. If this witness is correct, the driver of the vehicle violated the Tesla disclaimer that reads the autopilot feature “is an assist feature that requires you to keep your hands on the steering wheel at all times.” Some experts argue these manufacturers have to be more upfront about the limitations of their autopilot feature and how drivers should be cautious in the use of this advanced technology. It is no question that the driver of the Tesla (if you can call him that?) was reckless in the use of this technology. But what about the liability of the vehicle manufacturer?

The deceased’s family hired a product defect litigation law firm to conduct an investigation in conjunction with the federal government’s investigation. The goal of these investigations was to determine if Tesla is at fault for the vehicle’s autopilot feature failing to stop. Recently, news broke that the government investigation concluded that no recall must be made for the Tesla vehicles nor did the government levy any fines to the automaker. The government reported that the autopilot feature was not defective at the time of the crash because it was built to protect the driver from rear-end collisions (the man’s car rear-ended a truck) and also gave notice to consumers that the driver must remain fully attentive to the operation of the vehicle.

Legally, it appears that plaintiffs won’t likely have much luck in suits against Tesla in cases like this. The company requires purchasers to sign a contract stating the autopilot function is not to be considered self-driving and that they are aware they will have to remain attentive and keep their hands on the wheel at all times. However, Tesla operates on an interesting structure where purchasers buy directly from the manufacturer which may give them more of the ability to engage in these types of contracts with their consumers. Other automobile manufacturers may have a more difficult time maneuvering around liability for accidents that occur when the vehicle is driving itself. Car companies are going to have to ensure they provide repeated reminders to consumers that, until technology is tested and confidence in the feature is significantly higher, that the autopilot features are in the beta-testing mode and driver attention and intervention is still required.

The Rise and Fall of a Scholarly Crowdfunding Article

March 10, 2017
Economics, Financial Law, Regulatory

Tim Joyce, Editor-in-Chief, MJLST Vol. 18

Print publication of science and tech articles is a weird thing. On the one hand, a savvy articles selection team will prioritize articles on the most pressing and innovative advancements in the field. On the other, though—and precisely because these articles are so current—a draft piece can be partially outdated even before the publisher’s pressing start rolling. So it is that a little piece on investment crowdfunding, conceived in September 2015, meticulously researched throughout the 2015–16 academic year, and selected in April 2016, for publication in January 2017, can transform from forward-looking thinkpiece to historically-dated comparison piece.

My recent article with MJLST, 1000 Days Late & $1 Million Short: The Rise and Rise of Intrastate Equity Crowdfunding, compares the newly-activated federal Regulation Crowdfunding to Minnesota’s intrastate investment crowdfunding model MNvest. When the piece was originally conceived both of these laws were not yet active; in fact, it was not yet clear that the SEC would ever release final rules for what would become Regulation Crowdfunding. When the issue was ultimately sent to the printers, each of the laws had been active for at least 6 months. Like I said, weird.

This post is intended to update the curious reader on current happenings with investment crowdfunding on both a federal and a state level.

On the federal level, Regulation Crowdfunding rules have been final since October 2015 and active since May 2016. Nearly 200 offerings later, analysts and scholars are already starting to crunch the numbers. [Full disclosure: I am one of those academics. Our paper (co-author Zach Robins of Winthrop & Weinstine) will be presented at the Mitchell-Hamline Law Review Symposium next month, if you’re interested.] Similar to rewards-based crowdfunding models like Indiegogo and Kickstarter, there appear to be some things a crowdfunding issuer can do to increase the likelihood of success of their offering. Here are some examples.

First, a clear business plan is essential to attracting investors. After all, the “crowd” is made of lots of folks without sophisticated investing experience; so you have to find a creative way to hook them without violating securities disclosure restrictions. This isn’t always as easy said than done, and some portal operators have already gotten in serious trouble for violating their obligations to ensure offering accuracy.

Second, and perhaps a bit counterintuitive, the most successful Regulation Crowdfunding issuers actually have slightly higher minimum investments than you would expect. There is no dollar floor to the investment under the rules of Reg CF, but a small minimum opens the door to a potentially unwieldy cap table. In addition, a high minimum investment decreases the number of available spots for investors in the targeted offering amount; there is a very real “exclusivity” effect. To illustrate: it takes 10,000 investors at $10/per to get to $100,000 offering, but you could raise the same $100,000 with only 100 investors at $1,000/per. Issuers get to choose which investors they take on in oversubscription situations, and it can’t hurt to create a little buzz as investors “compete” for limited spots in the offering.

Finally, communicating the business plan using a strong video is a must—industry analysts report that campaigns using any video at raised significantly more money that those without (on the order of 11:1 times more money!). If that video is of good enough quality, according to those same analysts, your offering does even better. Of course, video quality only matters if your network is sufficiently large to reach enough potential investors. For issuers hoping to raise $50,000, that generally means connecting with more than 3,000 people.

There are plenty more nuggets of wisdom to glean from the first 8 months of federal investment crowdfunding offerings, and this post only scratches the surface. For more, see our forthcoming paper in Mitchell-Hamline Law Review’s symposium issue later this year.

As for MNvest, unfortunately, while the law has been technically available for Minnesota crowdfunders since June 2016, it took until the end of the year for the Department of Commerce to approve any portals. So only a handful of issuers and portals are currently active in the space. True to form, for federal crowdfunding offerings at least, craft breweries are making a strong showing (read: in Minnesota, 4 of the first 4 MNvest issuers are breweries!). Hopefully we’ll see more of them as the vehicle becomes more well-known.

One thing that should further aid MNvest issuers is that the SEC recently released final rules that will make it easier and safer for intrastate issuers to use the internet to advertise. Before the rules update, issuers were bound by advertising and solicitation restrictions drafted in the 1970s (that is, before the interwebs). As crowdfunding, almost by definition, requires the use of the internet to reach a crowd, these updates should streamline and loosen up the fundraising process. The new final rules create a new exemption (Rule 147A); state legislatures that based their intrastate laws on old Rule 147 will need to update their laws accordingly first.

Investment crowdfunding laws of the intrastate and federal varieties hold promise for many issuers. And, while there is not yet a perfect model or a one-size-fits-all strategy for fundraising, it is clear that investors and issuers alike are excited by the promise this investment vehicle holds.

Who knows—perhaps in another 18 months the way we crowdfund will have experienced as much change again, to make this piece as quickly “historical” as my earlier article!

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