Author Archives: Amy N. Westergren

New Mexico Poised to Add the ‘Data Breach Notification Act’ to the Patchwork of State-Level Data Privacy Laws

The New Mexico Legislature passed the ‘Data Breach Notification Act’ (the Act) on March 15. The Act is now with Governor Susana Martinez who has 20 days from the date the Act was passed to sign it into law. If enacted, the Act would require a person, other than a person who is subject to the Health Insurance Portability and Accountability Act of 1996 or the Gramm-Leach-Bliley Act, that “owns or maintains” records containing a New Mexico resident’s personal identifying information (PII) to notify the resident if his or her PII is “reasonably believed” to have been subject to a security breach. In most cases, notification will be required within 45 days.

Under the Act, PII is defined as an individual’s last name and first name or first initial in combination with one or more specified data elements, when the data elements are not Continue reading

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Filed under Privacy and Security, Technology, Uncategorized

The ‘Searching for and Cutting Regulations that are Unnecessarily Burdensome Act’ Passes the House

On March 1st, the U.S. House of Representatives (House) passed the Searching for and Cutting Regulations that are Unnecessarily Burdensome Act (SCRUB Act) by a vote of 240 to 185, split mostly along party lines. If passed by the U.S. Senate and signed by President Trump, the SCRUB Act would establish the Retrospective Regulatory Review Commission (Commission) to find and recommend regulations for repeal, implement “cut-go” procedures for executive agencies to repeal certain regulations identified by the Commission, and provide for the future review of new rules every 10 years. It is unclear when and if the Senate will take up the SCRUB Act. However, the Act seems to be consistent with President’s stated goal of reducing the number and burden of regulations.

If the bill is enacted as passed by the House, the SCRUB Act would charge the Commission to review the Code of Federal Regulations to identify rules or sets of rules for repeal based Continue reading

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Filed under Health Care, Health Reform

Deadline Looms for Pharmaceutical Manufacturers and Distributors to Comply with New Expanded Access Program Reporting Requirements

Certain pharmaceutical manufacturers and distributors of an investigational drug under an investigational new drug (IND) application must make their policies for evaluating and responding to requests under an expanded access program “public and readily available” by the end of this week pursuant to section 3032 of the 21st Century Cures Act (Cures). Cures, which became effective on December 13, 2016, provided a deadline for making the policies available on the later of: (i) 60 days after the enactment of Cures, or (ii) the first initiation of a phase 2 or phase 3 study with respect to the investigational drug. Therefore, the 60-day deadline expires on Saturday, February 11, 2017, for those manufacturers and distributors who are already conducting a phase 2 or 3 study under an IND. Continue reading

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Filed under Clinical Trials, Compliance, FDA