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 →

First Court Ruling that ADA Title III Accessibility Applies to Website

Last week, Florida Federal District Judge Robert Scola ruled that Title III of the ADA required the Winn-Dixie website to be accessible to people with disabilities. In a bench trial, the plaintiff, a blind man using screen reading technology to access the internet, obtained injunctive relief.   Title III prohibits discrimination against people with disabilities in places of public accommodation.  This is the first court to hold that Title III accessibility requirements apply to a virtual space.  Judge Scola issued a verdict and draft injunction holding Continue reading →

Fewer Than Half Nation’s Physicians Are Now Independent

For the first time, Modern Healthcare reports than less than 50% of the nation’s physicians own their own practices.[1]  According to a study released last week by the American Medical Association, the trend toward an employment model is continuing in healthcare.[2]  However, physicians are not necessarily becoming hospital employees.  While hospital systems were busy acquiring practices between 2012 and 2014, practice acquisition seems to have leveled in 2015.  Rather, the practice structure trend toward larger physician owned practices of 50 or more physicians, with fewer Continue reading →

CMS to Delay New Home Health Agency Rule

CMS is proposing a six-month delay for implementation of the new final home health agency rule.  CMS is seeking to change the effective date of the rule from July 13, 2017 to January 13, 2018. The new rule updates the conditions of participation for federal Medicare and joint federal-state Medicaid programs.  The conditions add operational requirements to enhance integration and coordination of patient care.  The regulation aims to improve the continuity of care through the agencies and the patient’s physicians.  Additional requirements include written instructions Continue reading →