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

Winstead PC Shareholder Taylor White published the first article for his column in Texas Lawyer about labor and employment issues and trending topics. The article is titled “Best Practices and Considerations for Employers Regarding the COVID-19 Vaccine in the Workplace.” The article is below:

“With states individually rolling out the COVID-19 vaccine to residents, employers are, and should be, beginning to consider their options with respect to employee vaccinations. The Centers for Disease Control and Prevention (CDC) has previously recommended giving the COVID-19 vaccine in phases initially, as it relates to employees: (1) health care employees; then, (2) frontline essential employees, such as education workers, manufacturing workers, first responders, and food and agricultural workers; and then, (3) other essential workers, such as construction workers, finance workers, and transportation and logistics workers. Of course, ‘the goal is for everyone to be able to easily get a COVID-19 vaccine as soon as large quantities are available.’ Continue Reading Taylor White in Texas Lawyer: Best Practices and Considerations for Employers Regarding the COVID-19 Vaccine in the Workplace

Winstead Shareholder Sarah Churchill Llamas presented a webinar for TMLT titled “New Law Impacting your Practice: Information Blocking.”  In the webinar, Sarah discusses the new Information Blocking rule that goes into effect on April 5, 2021. This rule affects patient access to data and system interoperability and it is intended to improve the electronic exchange of health information among payers, providers, and patients. These policies — it is predicted — will play a key role in reducing overall payer and provider burden and improving patient access to health information.

Upon completion of this video, viewers will be able to:

  • Understand the significance of criminal liabilities in the practice of medicine;
  • Address billing practices that could lead to civil and/or criminal liability; and
  • Evaluate how privacy practices and EHR security can prevent HIPAA penalties.

Click here to view. 

On Tuesday, December 15, Matthias Kleinsasser presented at the Austin Bar Association’s Health Law Section meeting. His presentation, titled “The Basics of the False Claims Act, STARK, and Anti-Kickback Statute and Recent Regulatory Developments,” provided a litigator’s perspective on the basics of the False Claims Act, STARK, and the Anti-Kickback Statute, along with a short discussion of potential pitfalls based on recent legal developments.

Resource:

The Basics of the False Claims Act, STARK, and Anti-Kickback Statute and Recent Regulatory Developments

With COVID-19 surging as the United States enters the winter months and holiday season, employers in all industries can expect to grapple with significant COVID-19 hazards for the foreseeable future. Employers in the healthcare industry though are doubly burdened not only by increased workloads stemming from higher numbers of ill patients, but also by increased health and safety risks for their workers. Accordingly, healthcare employers should pay close attention to guidance and updates from the Occupational Safety and Health Administration (OSHA) and implement appropriate plans and protocols—if not already in place—to address COVID-19 hazards to their workers.

OSHA recently announced that, through November 5, 2020, it had issued 204 citations based on alleged violations related to COVID-19. These citations resulted in $2,856,533 worth of proposed penalties and generally stemmed from complaints, referrals, or fatalities in a number of essential industries, such as “hospitals and healthcare, nursing homes and long term care settings, and meat/poultry processing facilities.”

Continue Reading Healthcare Industry Employers, Take Heed: OSHA Issues Most Cited Standards Related to COVID-19 Hazards

Winstead PC Shareholder Sarah Churchill Llamas recently spoke with Medpage today about the federal emergency orders in response to the Covid-19 pandemic that currently allow physicians to prescribe opioid medications to patients via telemedicine. An excerpt is below:

“In the COVID-19 era, under relaxed federal emergency orders, licensed clinicians have been able to prescribe opioid analgesics for their patients even if they’ve only ever seen the patient via telehealth, rather than in person.

For providers like Stephen Bekanich, MD, a palliative care physician for Ascension Texas in Austin, this provision allows him to help seriously ill patients without requiring in-person visits that may be difficult for them or could expose them or their caregivers to the virus.

Continue Reading Sarah Churchill Llamas in Medpage Today: Docs Can Prescribe Opioids Via Telemedicine, for Now

In the wake of the initial months of the COVID-19 pandemic, many practitioners have started to see a notable uptick in healthcare M&A activity through the third quarter of 2020.  Such activity spans from consolidation transactions in certain medical practice segments, accretive acquisitions in the hospice and home health space, business combinations to expand telemedicine offerings, and a growing interest in value-add healthcare real estate opportunities.  In most cases, the seller parties that have weathered the COVID-19 storm have done in so in part through the lifelines of funding provided by the U.S. Small Business Administration (SBA) through the CARES Act, and in particular Paycheck Protection Program (PPP) loans.  However, as the healthcare M&A deals initially inked in Q3-2020 now shift to closing mode in Q4-2020, these PPP loans are presenting new challenges for both sellers and buyers.  The following highlights some of the key issues.

Continue Reading Healthcare M&A in a Post-PPP World: Time to Look that Gift Horse in the Mouth

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

There’s no such thing as a free lunch….  This adage is over 50 years old, and the Office of Inspector General for Health & Human Services (OIG) wants to remind doctors that it remains true.

The pharmaceutical and medical device industry continues to woo doctors with invitations to educational speaker programs in high-end restaurants, with golf excursions, or at sporting venues.  On Monday, November 16, the OIG issued a new Special Fraud Alert to remind doctors that speaker programs sponsored by pharmaceutical and medical device companies must serve a legitimate educational purpose and must be appropriately tailored to meet a need in the medical community.

The Open Payments Act requires pharmaceutical and medical device companies to report their spending on entertainment.  According to Open Payments data, cumulative doctor payments in the three years from 2017-2019 exceeded $2 billion, and the OIG emphasized that this high amount of spending, and its potential to influence the prescribing or ordering habits of targeted physicians, was one of the reasons for this new alert.

Continue Reading There’s No Such Thing as a Free Lunch

Today, November 12, Shareholder Sarah Churchill Llamas moderated the panel discussion “Successful Raises and Investor Considerations” at the Texas Life Science Venture Forum, hosted by Rice Alliance for Technology and Entrepreneurship and BioHouston. The panel discussed advice for entrepreneurs/inventors that impacts valuation; the specific risks that erode valuation and how companies can mitigate risks at various stages of growth; and approaches to increase a company’s valuation once you are invested or engaged.

The Texas Life Science Forum is the premier life science event in Texas that brings together members from industry, emerging life science companies, academic, and investors. The event represents an opportunity to meet investors, learn about promising life science companies, to learn about opportunities for entrepreneurs, investment professionals, big pharma, academics and business executives serving the life science industry.

Panelists:

  • Mark Chandler, Managing Director, Upstream Partners
  • Aaron G.L. Fletcher, PhD, Managing Partner & Co-Founder, Bios Partners
  • Jack Henneman, Director, Alafair Biosciences