Blog Post

The Use Of 3D Printing In Medicine

By: Samantha Dente

The next great frontier in medical advancements is the use of 3D printing. Although the use of 3D printing in medicine is still in its beginning stages, there are already huge implications from its use.

Most recently in September, a cancer patient received a 3D printed titanium sternum and partial rib cage to replace the bones he had lost during cancer treatment.[1] Compared to traditional flat plate implants, which tend to loosen over time and thus require follow up invasive procedures for maintenance or replacement, the success of the surgery marks a breakthrough in the medical community.[2] In addition to the more durable material, another benefit of 3D printed implants is that the implant can be made to resemble the patient’s actual anatomy with the aid of CT scans.[3]

In August, another breakthrough occurred when the FDA approved a 3D printed prescription pill for consumer use to treat epilepsy.[4] The 3D technology allows pills to be made more porous which allows them to dissolve faster and thus act quicker.[5] Before that, in 2013, a two-year-old girl born without a trachea received a 3D printed windpipe built with her own stem cells. [6]

One of the biggest areas of concern is how the use of 3D printing will change research and development (R&D) for medical device manufacturers and pharmaceutical companies.[7] One of the foreseeable functions 3D printing is the ability to print tissues and organs for drug testing, which would in turn eliminate the need for animal testing or synthetic models which are less accurate.[8] Currently, the average R&D cost for a new drug is approximately $4 billion and the failure rate of drugs in clinical trials is 90% due to differing animal and human responses to testing.[9] By lowering the risk of trial failure, this would lead to a reduction of cost and clinical trial failures.

In 2013, the U.S. funded the “Body on a Chip” project, and just this year the first organ chips are coming to market.[10] In an effort to curb the issues with R&D described above, the project encouraged universities to essentially 3D print organs through the following process: prints of sample tissue meant to mimic human organs are placed on a microchip and connected with a blood substitute to keep cells alive. [11] This allows doctors to more accurately test specific treatments and monitor their effectiveness.[12] The military has shown interest in this project in the hopes of one day developing treatments for nuclear and biological incidents and has funded about $39 million into projects at Harvard and MIT.[13]

Although there was concern over FDA roadblocks, it has surprisingly expressed openness to the use 3D printing in R&D.[14]

It has been about thirty years since 3D printing technology was first introduced, and the biotechnology community is finally harnessing its true power and potential.[15] It has been predicted that patients eventually may be able to print their own medicines at home, which would in turn lead to a transition in how medications are prescribed.[16] It may seem like science fiction, but it is a possibility that could become a reality sooner than we think.

 

[1] Kelly Hodgkins, Cancer Patient Undergoes World’s First 3D Printed Sternum Replacement Surgery, Digital Trends (Sep. 11, 2015), http://www.digitaltrends.com/cool-tech/sternum-ribs-3d-print-implant/.

[2] Id.

[3] Id.

[4] Dominic Basulto, Why It Matters That the FDA Just Approved The First 3D Printed Drug, The Washington Post (Aug. 11, 2015), https://www.washingtonpost.com/news/innovations/wp/2015/08/11/why-it-matters-that-the-fda-just-approved-the-first-3d-printed-drug/.

[5] Id.

[6] Zuzanna Fiminska, 3D Printing Set To Revolutionize Pharma, Eye For Pharma (July 15, 2014), http://social.eyeforpharma.com/clinical/3d-printing-set-revolutionize-pharma.

[7] Id.

[8] Id.

[9] Id.

[10] Towards a Body-On-A-Chip, The Economist (Jun 13, 2015), http://www.economist.com/news/science-and-technology/21654013-first-organ-chips-are-coming-market-and-regulators-permitting-will-speed.

[11] Fiminska, supra note 6.

[12] Id.

[13] Towards a Body-On-A-Chip, supra note 10.

[14] Basulto, supra note 4.

[15] Bethany Gross, Evaluation of 3D Printing and Its Potential Impact on Biotechnology and Chemical Sciences, Analytical Chemistry (Jan. 16, 2014), http://pubs.acs.org/doi/pdf/10.1021/ac403397r.

[16] Basulto, supra note 4.

The Right to Privacy: Walking on Thin Ice

By: Jeffrey Cullen

The recent proposition by Britain’s MI5 Security Service raises the question whether measures to prevent potential terrorist plots are more important than guaranteeing the privacy of citizens’ communication on the Internet. The constant upgrades in technologies have caused difficulty in law enforcement’s ability to identify and eliminate potential terrorist threats. According to MI5’s Chief, Andrew Parker, there have been six attempted terrorist attacks in Britain in the past year, raising Britain’s terrorism threat level to “severe”.[1]

Parker has called for increased surveillance support from United States tech companies.[2] Parker commented these companies have an ethical responsibility to provide more help in monitoring communications that are suspect to be terroristic.[3] “MI5 and others need to be able to navigate the Internet to find terrorist communication, we need to be able to use data sets to be able to join the dots to be able to find and stop the terrorists who mean us harm before they are able to bring plots to fruition.”[4] The rapid change and growth in technology has made navigating and finding communications increasingly difficult.

Some major Internet companies have made encrypted messaging available to their users.[5] Encrypted messaging allows users to communicate with each other without surveillance from the provider of the service. The service provider’s inability to see these communications also means the government is unable to view them. People posing potential threats have been able to exploit encrypted communications, allowing them to hide their plans from authorities.[6] Parker commented, “The way we work these days has changed as technology has advanced. Our success depends on us and our partner agencies having sufficient up-to-date capabilities, used within a clear framework of law against those who threaten this country.”[7] Parker reassured the purpose for the increased surveillance is not to survey citizens’ private lives, but solely to identify terrorist threats.[8] However, this proposal calls into question the extent to which surveillance has already gone and how much further it may go.

Those in opposition to increased surveillance are skeptical due to Edward Snowden’s revelations of the United States and Britain “conducting mass monitoring of communications.”[9] Further, phone and Internet executives voiced their concerns of customers’ trust and the violation of civil liberties.[10] However, Parker emphasized increased surveillance is required. “[I]f we lose that ability, if parts of the radar go dark and terrorists are confident that they are beyond the reach of MI5 and GCHQ, acting with proper legal warrant, then our ability to keep the country safe is also reduced.”[11]

In the United States, the National Security Agency (NSA) has been searching the contents of Americans’ email and text communications to foreigners outside the country without warrants. Officials justify this surveillance in accordance with the 2008 FISA Amendments Act “in which Congress approved eavesdropping on domestic soil without warrants as long as the ‘target’ was a noncitizen abroad.”[12] The intention of this law was to gather intelligence pertaining to foreign organizations. This Act works by gathering all communications sent outside the country. The communications are then sifted through and searched for keywords in order to minimize the number of innocent communications that were flagged. The rest of the communications are deleted.[13] The deputy director of the NSA said they do not target any American’s content without a warrant. However, the rule written approved such surveillance as long as the NSA proves that one of the participants in the communication is outside the United States.[14] With this already open standard, should a treaty be reached between MI5 and United States companies like Google and Facebook to broaden surveillance, how much further will private citizen communications likely be opened?

 

 

[1] Michael Holden, UK MI5 spy chief calls for more powers to counter terror threat, Reuters (Sept. 17, 2015), http://www.reuters.com/article/2015/09/17/britain-security-idUSL5N11N0YB20150917

[2] Ewen MacAskill, MI5 chief calls for more up-to-date surveillance powers, The Guardian (Sept. 17, 2015), http://www.theguardian.com/world/2015/sep/17/mi5-chief-calls-for-more-up-to-date-surveillance-powers

[3] Id.

[4] Id.

[5] Id.

[6] Holden, supra note 1.

[7] Thomas Tamblyn, MI5 Chief Calls for Increased Surveillance Capabilities Ahead of ‘Snoopers Charter’ Bill, The Huffington Post (Sept. 17, 2015), http://www.huffingtonpost.co.uk/2015/09/17/mi5-chief-calls-for-increased-surveillance-capabilities-ahead-of-snoopers-charter-bill_n_8152932.html

[8] Id.

[9] Holden, supra note 1.

[10] MacAskill, supra note 2.

[11] Terrorism, Technology and Accountability, Security Service MI5 (Jan. 8, 2015), https://www.mi5.gov.uk/home/about-us/who-we-are/staff-and-management/director-general/speeches-by-the-director-general/director-generals-speech-on-terrorism-technology-and-accountability.html

[12] Charlie Savage, N.S.A. Said to Search Content of Messages to and From U.S., The New York Times (Aug. 8, 2015), http://www.nytimes.com/2013/08/08/us/broader-sifting-of-data-abroad-is-seen-by-nsa.html?pagewanted=all&_r=1

[13] Id.

[14] Id.

Immigration Technology: Avoiding a Jacquerie

By: Kory Crichton

The United Nations memorialized the freedom of movement, where every human being has “the right to leave any country, including his own, and to return to his country.”[1] 165 years before the Universal Declaration of Human Rights, United States President George Washington emphasized the value of immigration:

“The bosom of America is open to receive not only the Opulent and respectable Stranger, but the oppressed and persecuted of all Nations and Religions; whom we shall welcome to a participation of all our rights and privileges, if by decency and propriety of conduct they appear to merit the enjoyment.”[2] [emphasis added]

Government can establish and enforce a system that welcomes immigrants and benefit from their wealth of experience and expertise, while minimizing the associated risks. How far can a government regulate immigration before (1) encroaching upon the right to freely move, and (2) losing the innovative gains of immigration?

As is evident by the 2016 presidential elections, the merit of an immigrant group is informed by cultural values and biases. Fear and ethnocentrism are dominant values expressed on the campaign trail. These values breed hate, a perverted sense of nationalism, and a false sense of security.

The frontrunners in this election have advocated building walls—a technology of ancient times and a present day symbol of apartheid. On one side of the aisle the leading candidate voted for a discomfiting piece of legislation known as the “Secure Fence Act of 2006.”[3] The Act, amongst other provisions, called for a wall to stretch 700 miles along the Mexican border from California to Texas.[4] The other side of the aisle pledged with bombastic rhetoric: “I will build a great, great wall on our southern border and I will have Mexico pay for that wall. Mark my words.”[5]

Ironically, the United States’ economy is driven by “service industries, where free cross border movement of talent is increasingly important to economic health.”[6] When it comes to immigration, inflaming the passions of jingoism adversely impacts our economic prosperity and national security. Throughout history, addressing challenges with divisive values has favored faddish symbols over human progress.

In addressing the deficiencies of the U.S. Visa System, a state governor compared visas to FedEx: “You go on online and at any moment, FedEx can tell you where that package is. Yet we let people come into this country with visas, and the minute they come in, we lose track of them.”[7] Then, he offered “FedEx founder Fred Smith to come and work for the government to show U.S. Immigration and Customs Enforcement (ICE) how to set up a system for tracking people.[8] The suggested technology is reminiscent of the movie Eagle Eye, where the government designed a system to track people, which ultimately developed autonomous capabilities to research, study, spy upon, and attempt to kill Shia LaBeouf.[9] Designing a system to track immigrants like they are FedEx packages lends itself to abuse.

Far from these erratic suggestions proposed by petulant voices, there are reasonable proposals that offer practical solutions. In 2014, President Barack Obama issued a memo discussing five necessary steps to update the U.S. Visa System: (1) developing a cross-agency digital services team to improve user experience and adjudicative efficiency, (2) redesigning “systems with an eye towards human perspective and accessibility,” (3) establishing “a communication task force to create clearer, plain-language instructions,” (4) improving “content management”, and (5) creating “an interagency task force to enhance data collection.”[10] In contrast, this suggestion by the President promotes values that do not involve building a wall or tracking devices. Rather, they involve the recognition of the United States as a country founded and built by immigrants.

Our Southern border and the U.S. Visa System are one of many issues plaguing the current immigration process. Apartheid and invasive technologies have no place in our society. The discussion needs to be about humane solutions for resolving the difficulties of the United States’ immigration system.

In 2016, which set of values will you vote for?

 

[1] G.A. Res. 217 (III), art. 13, (Dec. 10, 1948).

[2] George Washington, “Address to the Members of the Volunteer Association of Ireland, December 2, 1783,” in John C. Fitzpatrick (ed.), The Writings of George Washington (Washington DC: Government Printing Office, 1921, vol. XXVI, p. 254.

[3] H.R. 6061, 109th Cong. (2006) (where Hillary Clinton voted “Yea,” the bill ultimately passed in the Senate, and construction of the wall has already taken place).

[4] The Secure Fence Act of 2006, Pub. L. 109-367, 120 Stat. 2638 (Oct. 26, 2006).

[5] Donald Trump, Donald Trump Presidential Announcement Full Speech 6/16/15, YouTube (June 16, 2015), https://www.youtube.com/watch?v=0XXcPl4T55I.

[6] Kenneth J. Harder, Immigration Law, 74 Tex. B.J. 34, 35 (2011).

[7] Raul A. Reyes, Christie’s laughable FedEx solution on immigration, CNN, (Aug. 31, 2015), http://www.cnn.com/2015/08/31/opinions/reyes-chris-christie/.

[8] Id.

[9] Eagle Eye (DreamWorks Pictures 2008).

[10] The White House, Office of the Press Secretary, Modernizing & Streamlining Our Immigration System for the 21st Century, (July 15, 2015), at 5.

Ashley Madison and the Legal Battle Over Data Protection

By: Jonathan Ziarko 

“Life is short. Have an affair,” – the now infamous tagline of Ashleymadison.com. This summer the website was subject to one of the largest data breaches yet. Ashley Madison is a website owned by Avid Life Media, and it provides an online dating service for people who are already in a relationship. [1]

The hack, perpetrated by “The Impact Team,” a group of hackers who are taking credit for this massive data breach, is just one in a long line of data breaches of websites and companies.[2] In late August the hackers released the data of 33 million website users including their user names, real life addresses, phone numbers, passwords, email addresses, and potential credit card information.[3] Around 15,000 of the email addresses in the data file have been linked to the U.S. military or government addresses.[4] Access to the data could have a real impact on the people who are linked to the accounts. There is a serious possibility that the information leaked could be used to blackmail people who do not want their membership to such a website revealed. In fact, simply being on the list could put marriages in jeopardy.[5] The revealed information has already been linked to two suicides in Canada.[6]

So far there have been four class action suits brought against Avid Life Media, including one originating in Canada.[7] Avid Life Media is facing damages up to around $578 million from the Canadian lawsuit alone. [8] The lawsuits originating in the U.S. have yet to specify damages or even gain class action status but it is alleged that Avid Life Media acted negligently by failing to exercise reasonable care in protecting and safeguarding personal information in their possession, breach of contract, and other privacy violations.[9] A major contention in the lawsuits is the fact that the website charged users a $19 fee to permanently delete all of their data, however the data was still available.[10] The hackers stated this is the reason why they targeted the website in the first place as an act of so-called “hacktivism,” in order to stop the website form taking money for not actually removing data.[11] Internal sources are showing that the company was aware of some of the potential vulnerabilities but took no steps to fix them.[12]

The outcome of these cases could very well be groundbreaking on the subject regarding how the law is shaped around data protection. To date it seems there is no security system that is impervious to hacking, even the government is susceptible. Can there ever really be a reasonable expectation that all the data we put out on the Internet will remain private? All that companies can do is to use the best security they can by following industry standards and by doing their best to contain a breach when it does occur. As these cases unfold it may in fact have a large impact on how Internet based services conduct business and store data. It no longer seems a question of can personal data be stored securely online, but rather how long until someone decides they want to take our information and share it with the world.

 

[1] Amanda Lee Myers, Americans Sue Ashley Madison Over Hack, Time Inc. (Aug. 25, 2015), http://time.com/4010665/ashley-madison-american-lawsuit/

 

[2] Meg Wagner, Adultery website Ashley Madison hacked; intruders threaten to leak 37 million users’ personal info, New York Daily News (July 20, 2015, 8:40 AM), http://www.nydailynews.com/news/national/adultery-website-ashley-madison-hacked-article-1.2297545

 

[3] Ashley Madison: What’s in the leaked account data dump?, BBC (Aug. 19, 2015), http://www.bbc.com/news/technology-33986228

 

[4] Id.

[5] Myers, supra note 1.

 

[6] Ashley Madison: ‘Suicides’ over website hack, BBC (Aug. 25, 2015), http://www.bbc.com/news/technology-34044506

 

[7] Myers, supra note 1.

 

[8] Id.

 

[9] Kim Zetter, Ashley Madison Hit With $500 Million In Lawsuits, WIRED (Aug. 25, 2015, 3:30 PM), http://www.wired.com/2015/08/ashley-madison-hit-500-million-lawsuits/

 

[10] Myers, supra note 1.

 

[11] Wagner, supra note 2.

 

[12] Zetter, supra note 9.

 

Selfie Sabotage: When Narcissism Leads to Self-Incrimination

By: Ariana Doty Let me take a selfie. A 2012 survey found that four out of five law enforcement officials used online networks such as Facebook and Twitter during criminal investigations due to the increase in the number of criminals posting self-incriminating evidence.

Cyber Terrorism

By: Thomas Romano With the widespread increase in technological advancements throughout the world, cyber terrorism has become a national security concern for many countries. So, what is cyber terrorism?

E-Discovery

By: Sid Bahl With today’s technology changing at a rapid pace, the amount of electronically stored information increases at a tremendous rate. Electronic discovery (“e-discovery”) is the process of producing electronically stored information that is either relevant to a party’s claims or defenses.