June 03, 2021 | The Legal Intelligencer
Data Privacy and Life Sciences—Recent Developments May Impact ComplianceMany life sciences companies are involved in providing health care, either directly or as a business associate, or are developing products for us by health care providers that create, store or manipulate PHI. This means that these companies must comply with HIPAA, and their services and products must be capable of protecting the PHI with which they deal.
By Christopher Ezold
7 minute read
February 12, 2021 | The Legal Intelligencer
Life Sciences Business and Legal Trends to Watch in 2021While COVID-19 has had an obviously enormous impact on the American economy and on investing in general, that impact has been less severe in the life sciences sector.
By Christopher Ezold
10 minute read
August 07, 2020 | The Legal Intelligencer
The FDA and COVID-19: Streamlined Processes and EnforcementThe FDA has taken steps to both accelerate the biotech and life sciences industry's work to test, diagnose and treat COVID-19 as well as rein in misguided or unscrupulous COVID-19 products.
By Christopher Ezold
6 minute read
February 14, 2020 | The Legal Intelligencer
Life Sciences and Medical Tech Legal Trends for 2020The life sciences and medical technology space is growing rapidly; trends in this space for 2020 reflect this growth. This article addresses the trends to expect, and how that may impact the work their attorneys will be facing in 2020 and beyond.
By Christopher Ezold
6 minute read
August 09, 2019 | The Legal Intelligencer
Biotech Industry Must Plan for Data Security Compliance NowIn 2013, the Federal Department of Health and Human Services (HHS) issued final omnibus amendments to regulations arising under the Health Insurance Portability and Accountability Act (HIPAA).
By Christopher Ezold
6 minute read
June 05, 2019 | The Legal Intelligencer
HIPAA's Business Associate Traps for Biotech and Life SciencesSince its inception, the Health Insurance Portability and Accountability Act of 1996, (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.
By Christopher Ezold
7 minute read
April 11, 2019 | The Legal Intelligencer
FDA Moves Toward a Streamlined Regulatory Process for Artificial IntelligenceA 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.
By Christopher Ezold
5 minute read
February 19, 2019 | The Legal Intelligencer
Advising Life Sciences Clients on Private EquityIf you represent early stage life sciences companies entering the capital markets, you may be asked to opine on the financing and business issues they face. Below is a general overview of some of the issues that you will need to understand to provide solid advice.
By Christopher Ezold
9 minute read
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