HIPAA’s Business Associate Traps for Biotech & Life Sciences

Since inception, the Health Insurance Portability and Accountability Act of 1996, et seq. (HIPAA) has required that patient health information (PHI) be kept confidential. HIPAA meets this goal primarily through its Privacy Rule, Security Rule and Breach Notification Rule. “Covered Entities” such as physicians, hospitals and insurers were initially the only entities required to comply with these Rules. The increased use of digital media for storage and transmission of PHI lead to the passage of the Health Information Technology for Economic and Clinical Health Act Continue reading →

There’s No Such Thing as Boilerplate

The Philadelphia business attorneys of the Ezold Law Firm provide ongoing legal counsel and representation to our business and corporate clients, acting as general outside counsel. Part of what we do includes assisting our clients with reviewing and drafting contracts, as well as strategizing with regard to contract negotiations and terms. Just as each relationship with each client is unique, each contract is unique, and has to be approached in that manner. This means that when it comes to contracts, there really is no such Continue reading →

Common Noncompetition Agreement Mistakes by Employees

Noncompetition agreements (a type of contract known as a “restrictive covenant”) are far more commonplace in 2019 than they have ever been. Entry-level employees are regularly asked to sign them, frequently without knowing how they will affect their career down the line. These are very dangerous agreements; many times there are valid reasons for having them, but they can also be afterthoughts with wide-reaching implications for employees. I’m going to discuss several of the common mistakes made in negotiating and understanding noncompetition agreements by employees. Continue reading →

The FDA Moves Towards a Streamlined Regulatory Process for Artificial Intelligence

A question that investors frequently ask of emerging growth life sciences companies is whether they have considered how to monetize the data they will inevitably collect in the development, marketing and sale of their service or product. Data merely existing in a compilation can have value; analytics can increase that value by orders of magnitude. Beyond compilation and analytics is the use of data to provide direct treatment or services. Using artificial intelligence (AI) (smart machines that are developed to do work normally done by Continue reading →

Common Noncompetition Agreement Mistakes by Employers

Noncompetition agreements are an increasing part of the employment landscape. Once considered unusual and only for C-suite employees, they are routinely required of entry-level employees. These types of agreements are highly technical and must clear several legal hurdles to be enforceable. The result is that they are poorly understood and implemented. I’m going to discuss several of the common mistakes made in drafting and implementing noncompetition agreements by employers. Some common employer mistakes are: Surprising existing employees without compensation. Noncompetition agreements are contracts; all contracts Continue reading →

Advising Life Sciences Clients on Private Equity

Life sciences/biotech companies are a significant economic driver in the greater Philadelphia area, with an estimated 1,200 businesses employing nearly 50,000 people in 2017.[1]  In my experience, there is significant growth within the early stage life sciences sector; most will need to seek capital to grow to an inflection point.  Much financing is through angel investors; what used to be a purely venture capital space has opened up to professional angels, primarily through investment groups such as The Keiretsu Forum, the Mid-Atlantic Bio Angels and Continue reading →

Settlement of Commercial Litigation Matters: Approaches and Issues to Keep in Mind

Settling commercial disputes frequently implicates a wide range of issues than settling personal matters; in this article I will discuss approaches and issues to keep in mind in resolving commercial disputes. By Christopher E. Ezold | April 17, 2018 The themes of commercial disputes are often the same as those of personal disputes—someone feels a promise was broken, blames another for property loss, or believes a duty was shirked. Instead of divorce or personal injury claims, however, these themes play out within more complex structures, Continue reading →

Attorney Ezold Publishes Litigation Hold Letter Article in The Legal Intelligencer

Attorney Christopher E. Ezold, a managing partner at the Ezold Law Firm, recently published an article in “The Legal Intelligencer” regarding the importance of litigation hold letters. In the article, he discusses the importance of litigation hold letters for clients in commercial disputes, and how it helps them in their cases. He reviews the fundamentals and time tables for their submission, and how they protect clients. With over 20 years of experience in commercial, business, and employment matters, Mr. Ezold represents both business and individual Continue reading →

Data Security Now Part of Medicare Reimbursement Requirements

The Medicare Access and CHIP Reauthorization Act (MACRA) mandates the performance and maintenance of the information security risk assessment as part of Medicare reimbursement criteria. As reported in a recent article in healthdatamanagment.com, the Merit Based Incentive Payment System (MIPS) under MACRA requires group practices to update the assessment to security risks and document steps taken to mitigate those risks. The MIPS reimbursement scheme has four components.  The security risk assessment requirement falls within the Advancing Care Information (ACI) category.  The ACI category accounts for Continue reading →

What We Can Learn From HIPAA Settlements

A data breach at a business is serious enough, but when it involves a healthcare organization, there are greater ramifications. And when the sensitive nature of patient medical records are jeopardized, it can be costly. The Health and Human Services’ Office for Civil Rights (OCR) enforces HIPAA privacy and security rules, which safeguard patient medical information. A recent article in healthitsecurity.com took a look at settlements over the past two years, to share five lessons on what was overlooked and how confidential information can be Continue reading →