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 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

Tuesday, October 20, 2020 | 12:00 p.m. to 1:00 p.m. (EDT)

Winstead attorneys Frank Amini, Ph.D. and Lekha Gopalakrishnan, Ph.D. will present at an AUTM live webinar on the topic of protecting trade secrets on Tuesday, October 20, 2020. Trade secrets can be an institution’s most valuable and prolonged assets.

However, maintaining trade secrets in

On March 27, the CARES Act was signed into law by President Trump in an effort to stem the nationwide effects of the COVID-19 emergency crisis. Healthcare providers, in particular, are currently overwhelmed with the surge in COVID-19 cases. Consequently, the CARES Act allocates over $330 billion to the healthcare industry as a temporary economic respite and makes numerous policy changes to provide greater flexibility to healthcare providers as they continue to fight this disease from the front lines.
Continue Reading The COVID-19 Aid, Relief, and Economic Security (CARES) Act and its Effects on Healthcare Providers, Hospitals, and Other Professionals

On March 23, 2020, the Centers for Medicare and Medicaid Services (CMS) announced that during the next three weeks, State Survey Agency (SSA) and CMS surveyors will only prioritize and conduct surveys related to complaints and facility-reported incidents (FRIs) that are triaged at the Immediate Jeopardy level, in addition to an infection control review using an Infection Control Survey Checklist developed by CMS and the Centers for Disease Control and Prevention (CDC). 
Continue Reading CMS Prioritizes Immediate Jeopardy and Infection Control Surveys

We have already seen extensive regulatory responses to the COVID-19 public health emergency (visit Winstead’s COVID-19 Resource Center for more information). On March 24, 2020, the Office for Civil Rights (“OCR”), a department of the U.S. Department of Health and Human Services (“HHS”) issued guidance clarifying when entities covered under HIPAA and the Privacy Rule can disclose the protected health information (“PHI”) of patients exposed to COVID-19 to first responders and other individuals.
Continue Reading COVID-19 and HIPAA – Law Enforcement, First Responders and Public Health Authorities Can Get PHI

Under the Ryan Haight Act, healthcare providers must usually conduct an in-person examination before prescribing controlled substances, such as opioids, via the internet (including telehealth or telemedicine). However, as a result of the Public Health Emergency Declaration, the U.S. Drug Enforcement Agency (DEA) issued a statement clarifying that—for the duration of the Public Health Emergency—DEA-registered practitioners utilizing telehealth or telemedicine solutions do not need to conduct an in-person examination to prescribe Schedule II-V controlled substances so long as:

Continue Reading COVID-19 Emergency Update: Physicians Can Prescribe Controlled Substances via Telemedicine

On March 22, 2020 Texas Governor Greg Abbott issued an executive order prohibiting all surgeries and procedures that are “not immediately medically necessary to correct a serious medical condition of, or to preserve the life of, a patient” who would be at risk for serious adverse medical consequences or death without the immediate performance of the surgery or procedure. The determination is to be made by the patient’s physician. Procedures that would not deplete hospital capacity or supplies of personal protective equipment are allowed.

Continue Reading COVID-19 Emergency Update: Texas Governor Prohibits Elective Surgeries and Suspends Hospital Capacity Limits

The nation’s healthcare system is preparing to reach record capacity in the coming weeks. Much focus has been on the limited capacities of the nation’s acute care hospitals. As a result of the COVID-19 public health emergency, the Health and Human Services (“HHS”) Secretary is authorized to make temporary waivers under the Social Security Act (known as “Section 1135 Waivers”). In turn, the Center for Medicare and Medicaid Services (“CMS”) COVID-19 Emergency Declarations have expanded the ability to move patients from acute care setting to skilled nursing settings in an expedited manner to reserve hospital beds for the most severely ill patients.

Continue Reading Using Skilled Nursing Facilities to Expand Hospital Capacity During COVID-19 Crisis