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Healthcare providers continue to rely on interconnected information technology systems and digital care delivery to improve healthcare outcomes.  In response, ransomware attacks are increasing, both in number and in sophistication.  The attacks threaten the clinical and clerical operations of healthcare enterprises of all sizes.  JAMA published an alarming study to show that the number of ransomware attacks targeting healthcare organizations doubled in the last five years.  These attacks disrupted care and exposed the personal health information of nearly 42 million patients.

Ransomware attacks usually involve the installation of malicious software on vulnerable systems and technology through any number of vulnerabilities, such as email phishing links or disguised as software updates.  Once installed, the ransomware software locks healthcare organizations out of their own data, whole data storage systems, or targeted technology devices.  The cybercriminals behind ransomware attacks then threaten to release, permanently encrypt, or delete patient data—in some cases, all three—unless the organization pays the ransom demand.
Continue Reading Ransomware Attacks at Record Levels; Healthcare Organizations Must Be Ready Via Data Security and Disaster Response Policies and Procedures

Winstead Shareholders Katy Carmical, Corinne Smith and Kevin Wood recently discussed Medical Timeshares in a new American Health Law Association article.

The article can be read here: Medical Timeshares Require More Than What You Learned in Kindergarten

Big data entails nearly every aspect of commerce.  However, protecting big data as a form of intellectual property is complex.  For instance, patents, copyrights and trade secrets provide limited protection for datasets.  Moreover, the ownership of datasets can be uncertain.  Additionally, datasets may be subject to numerous regulatory laws.  In view of the aforementioned complexities, contractual agreements play a pivotal role in protecting and commercializing big data.

Big data is a valuable asset

Big data can be in many forms.  Such forms can include market data, consumer data, business records, health records, and experimental results.

Additionally, big data can find applications in numerous fields, including the healthcare and life sciences industries.  For instance, in the healthcare industry, data extracted from electronic health records can be supplied into a software with artificial intelligence (AI) or machine-learning algorithms for diagnostic applications, such as detecting early heart failure and predicting surgical complications[1].  Similarly, in the life sciences industry, DNA sequences generated through next generation sequencing techniques can be supplied to various AI-based software for the identification of potential drug targets[2].Continue Reading Big Data as a Valuable Asset: Avenues for Protecting and Commercializing Big Data through Contractual Agreements

In order to clarify the required procedures for changes of ownership of entities that have received Paycheck Protection Program (“PPP”) funds, the Small Business Administration (“SBA”), on October 2, 2020, released a Procedural Notice. Specifically, the Procedural Notice addresses the procedures companies with outstanding PPP loans must follow when undergoing a change of ownership, including mergers, equity or asset acquisitions, or ownership restructurings.[1]

Prior to the October 2, 2020 Procedural Notice, SBA loans typically required prior SBA approval for any transaction involving a change of ownership, regardless of the percentage change. Without further guidance from the SBA, PPP lenders have been cautious in granting their consent to their PPP borrowers’ change of ownership transactions without prior SBA approval in order to avoid potential defaults and forego forgiveness rights of the PPP loan.Continue Reading SBA Procedural Notice Summary – Changes of Ownership

As landlords and tenants continue to navigate the uncertainties of traditional office and retail properties in the era of COVID, one asset type that has emerged as more resilient in this new environment is life science real estate.[1] The spaces utilized by biotech and pharmaceutical companies, as well as medical research facilities, are highly technical, with site-specific functionality that cannot be replicated by remote work environments.  As a result, life science real estate continues to attract tenants and property owners continue to invest in this sector.  However, utilization of space for life science uses—wet and dry laboratories, warm rooms and cold rooms, and other activities—presents a number of specific issues for both tenants and landlords that should be considered in any lease transaction. Below is a summary of some of those issues from both a tenant’s and a landlord’s perspective.
Continue Reading Issues in Life Science Leases

How do you take a negative and turn it into a positive? COVID-19 has made answering this question very difficult, as the pandemic continues to have a negative and in some cases long lasting and devastating impact on people’s daily lives and the many businesses that help sustain daily living.  One area of business that has been hit particularly hard, as a result of the pandemic, has been the hospitality industry. According to a new national report completed by Trepp [1], the hotel industry is facing an unprecedented number of foreclosures as the COVID-19 pandemic continues to devastate small business hotel owners and its workforce. More specifically, American Hotel & Lodging Association (AHLA) conducted a survey of more than 600 hotel owner respondents and more than half of them stated that they are in danger of losing their property to foreclosure by commercial real estate lenders due to COVID-19.[2] As a result of these market conditions, some senior living developers and operators see a growing opportunity to capitalize on the hotel foreclosures by converting them to assisted living facilities.[3]  However, turning this negative into a positive won’t go without its challenges, and developers and owners should be mindful of some pitfalls when attempting to make this conversion a reality in Texas.
Continue Reading Hotel Conversions to Assisted Living in the Wake of COVID-19

Introduction

This article examines the different types of preferential rights in ground leases for medical office buildings, and examines strategies in drafting preferential rights provisions to protect the interests of both ground lessors and ground lessees.  Ground leases are a popular way for hospitals and health systems (collectively, “Hospitals“) to maintain ownership and control of their hospital campus, while also allowing them expand their campuses or monetize equity tied up in Hospital-owned buildings.  Typically, a ground lessee (or, the “MOB Owner“) is either a developer of, or investor in, medical office buildings (“MOBs“) who either develops the MOB or acquires an existing MOB from the Hospital and then subleases space within the MOB to physicians, physician groups or the Hospital itself.  Under a ground lease, typically the MOB Owner holds a leasehold interest in the real property and owns fee title to the building and other improvements located thereon for the term of the ground lease, and upon the expiration of the ground lease, title to the improvements reverts to the Hospital.Continue Reading Exploring Preferential Rights in Hospital Ground Leases

Startup? Organized in Delaware? Then you likely received a notice from the Secretary of State of Delaware saying you owe thousands (maybe even tens of thousands) in franchise taxes and have to file an Annual Report by March 1, 2020. DON’T PANIC!! There are two ways to calculate franchise taxes, and Delaware defaults to the…

In a long-anticipated move, the United States Food and Drug Administration (FDA), on September 26, 2019, published six guidance documents clarifying its scope of authority and enforcement discretion policies with regards to Digital Health Content in light of the questions raised by the 21st Century Cures Act (Cures Act).

In this article, we take a look at the FDA’s draft guidance that proposes a framework of regulating Clinical Decision Support (CDS) Software, including software containing machine-learning algorithms (ML).
Continue Reading FDA Guidance Clarifies Clinical Decision Support, Machine-Learning, and Other Digital Health Content

It is common practice for a hospital to require a physician to sign a non-compete agreement whenever the hospital employs the physician or acquires the physician’s medical practice. In certain respects, that is to be expected. Non-compete agreements are a common feature in employment agreements and business acquisition documents across all industries and therefore it…