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The Association of Corporate Counsel (ACC) is the world's largest organization serving the professional and business interests of attorneys who practice in the legal departments of corporations, associations, nonprofits and other private-sector organizations around the globe.

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Resource Listings

Articles

OCR Issues Guidance Regarding Disclosures Related to Reproductive Health Care

By Jonathan M. Ishee and Michael J. Paluzzi, Troutman Pepper Hamilton Sanders LLP

In the wake of the US Supreme Court’s decision to overturn Roe v. Wade, the US Department of Health and Human Services (HHS) Office of Civil Rights (OCR) issued new guidance to address patient privacy under the Health Insurance Portability and Accountability Act (HIPAA) for those seeking reproductive health care services. This article discusses the guidance, which states that HIPAA allows providers to disclose certain protected health information (PHI), which includes information relating to one’s abortion or other reproductive care, without patient authorization only in specific circumstances that are “narrowly tailored to
protect the individual’s privacy and support their access to health services.”

Sample Forms, Policies, and Contracts

Vendor Business Associate Agreement (US)

This sample agreement is intended to satisfy the covered entity’s, company’s, and vendor’s obligations under HIPAA and is incorporated into all applicable services agreements between the company and its contracted vendor.

Articles

Top 10 Patent and Regulatory Things You Need to Know when Bringing a Biopharma Product to Canada

By Nancy Pei, Principal, Alice Tseng, Principal, Toronto Office and Daphne Lainson, Principal, Ottawa Office, Smart & Biggar LLP

Canada is an attractive market for pharmaceutical manufacturers. Most Canadian consumers have some form of drug coverage through government programs and/or private insurance. Below are ten patent and regulatory topics that in-house counsel need to know before bringing an innovative product to Canada.

Editor's note: This article was updated to reflect recent developments; the original version of this article was published on December 16, 2020.

Articles

International Comparative Legal Guide to Digital Health 2024

By Global Legal Group

This guide provides corporate counsel and international practitioners with comprehensive jurisdiction-by-jurisdiction guidance to digital health laws and regulations around the world.

Topics covered include digital health technologies, data use, data sharing, intellectual property, commercial agreements, AI and machine learning, and liability.

Articles

10 Things You Need to Know about Life Sciences Patent Litigation in Canada

By Sheldon Hamilton, Principal, Smart & Biggar LLP, Barrister and Solicitor Patent and Trademark Agent, and Nancy Pei, Principal, Smart & Biggar LLP, Barrister and Solicitor Patent and Trademark Agent

Patented medicine regulations in Canada can be complex and the review process is fast-paced. In this Top Ten, in-house counsel will learn the essential points of how to prepare for the "Regulations" review. Editor's note: This article was updated to reflect recent developments; a prior version of this article was published on August 6, 2020.

Articles

Considerations When Conducting Decentralized Clinical Trials

By Kyle Y. Faget

Although use of telehealth in clinical trials is not new, the modality was not popularized until social distancing efforts brought about by COVID-19 forced the issue. Companies interested in providing clinical trial services via telehealth have to deal with whether the carrying out the clinical aspects of a clinical trial is part of the practice of medicine.

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