What’s in the Bottle? FDA Announces New Blockchain Pilot Program for Tracking Drug Distribution

Where does my prescription come from? Has it been altered or diluted? Can I trust the label? With millions of prescriptions filled each year, quality control and security across the pharmaceutical supply chain seems like a herculean task. In an attempt to slay this proverbial hydra, the Food and Drug Administration (FDA) developed a new pilot program – the DSCSA Blockchain Interoperability Pilot (the “Blockchain Pilot”) – which aims to use blockchain to create a secure electronic, interoperable system that tracks and traces certain prescription drugs as they are distributed in the United States. Continue Reading

Blockchain Continues to Make Headway in the Energy Industry

Recent developments in the energy sector indicate that blockchain technology is being embraced to address a range of issues including network security and improved integration of renewable generation and demand response resources. This emerging technology continues to have the potential to become a disrupter in the energy industry. Continue Reading

Open Source Software Policies – Why You Need Them And What They Should Include

The chances are high that your company uses open source software (“OSS”) in some capacity. While the benefits of OSS are clear, it is also clear that OSS can pose significant legal risks that must be addressed. The best way to manage these risks is to have a clearly written and enforced OSS policy. To understand why these policies are necessary, it is first necessary to understand the risks of not having one. Our recent paper identifies some of the key legal issues to understand when using OSS followed by some of the elements to consider in such a policy.

Blockchain and Healthcare Innovation: A City, Academia, and Technology Firms Join Forces to find Blockchain Solutions to Address Public Health Challenges

As the excitement around blockchain technology continues to grow in the healthcare sector, there is an increasing realization that blockchain has the capability of addressing many of the data and information-related challenges that the healthcare world has been focused on for years – such as providing access to comprehensive interoperable electronic health records and ensuring data continuity for patients who receive treatment in multiple healthcare settings. As this realization has taken hold, healthcare stakeholders and constituents are seemingly trying to “make up for lost time” with new blockchain initiatives being announced on a regular basis seeking to turn theoretical applications into real-world blockchain solutions.[1] Continue Reading

FinCEN – We Will Identify Where Compliance Is Not Taking Place And Take Appropriate Action

Last week we reported that FinCEN had issued new guidance addressing cryptocurrency and other convertible virtual currency. The need for compliance was reinforced this week. In a speech by Sigal Mandelker, Under Secretary for Terrorism and Financial Intelligence, during blockchain week in NY, a stern warning was issued. The message was clear. Regulatory compliance is not an option and you must do it right from the start – not just after you got a call from regulators or law enforcement.

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FinCEN Updates Guidance on Crypto

FinCEN has issued  2 new guidance documents addressing cryptocurrency and other convertible virtual currency (CVC). The guidance does not establish any new regulatory expectations. Rather, it consolidates current FinCEN regulations, guidance and administrative rulings that relate to money transmission involving virtual currency, and applies the same interpretive criteria to other common business models involving CVC. FinCEN’s rules define certain businesses or individuals involved with CVCs as money transmitters subject to the same registration requirements and a range of anti-money laundering, program, recordkeeping, and reporting responsibilities as other money services businesses. It also warns of threats posed by virtual currency misuse. Continue Reading

Popular Open Source Software under Patent Attack

Sound View Innovations is launching patent attacks against commonly used open source software including jQuery and Apache Hadoop. Sound View is targeting end users of these software components. This is a typical tactic of non-practicing patent assertion entities. Unlike some commercial software, most open source software is licensed with a disclaimer of any warranties regarding patent infringement. This makes it harder for end users to look to software publishers for indemnity. The interplay between patents and open source is often misunderstood. For clarification on some of these issues see our paper on Patent Issues with Open Source Software. Continue Reading

New Effort to Exempt Crypto Currency from Certain SEC, Tax and Other Regulatory Burdens

A new bill, the Token Taxonomy Act was introduced to congress to amend the Securities Act of 1933 and the Securities Exchange Act of 1934 to exclude digital tokens from the definition of a security, to direct the Securities and Exchange Commission to enact certain regulatory changes regarding digital units secured through public key cryptography, to adjust taxation of virtual currencies held in individual retirement accounts, to create a tax exemption for exchanges of one virtual currency for another, to create a de minimis exemption from taxation for gains realized from the sale or exchange of virtual currency for other than cash, and for other purposes. Continue Reading

SEC Issues First No Action Letter on Crypto Tokens

On April 3, 2019, the SEC issued its first no-action letter for a crypto token! This is a significant step in providing regulatory clarity for when a token is NOT a security or at least when the SEC will take no action on enforcement. The same day it also issued Framework for “Investment Contract” Analysis of Digital Assets (which we will cover in a separate blog post). Continue Reading

Blockchain Games and Collectibles – Patents and Other Legal Issues

The use of blockchain (or distributed ledger) technology for games (a.k.a blockchain games) and token-based digital collectibles is on the rise. The overnight popularity of CryptoKitties was as significant to raising the awareness of digital collectibles as Pokémon Go was to location-based AR games. However, the ecosystem extends well beyond CryptoKitties, and is growing rapidly. The ecosystem includes cross-platform crypto currency and tokens, digital asset marketplaces, digital collectibles, decentralized virtual worlds and more. A significant amount of investment is going into this space. Blockchain gaming startup Forte has announced a deal with Ripple’s Xpring crypto currency platform to invest $100 million in game developers who make games based on blockchain technology. While the opportunities in this space are real, there are a number of legal issues that can arise depending on how a company implements its offerings. Continue Reading

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