Since May 2021, Access has been pleased to provide you with quarterly updates on the latest legislation and regulatory news happening around the world. As previously described, our intent with these briefs, published chiefly for information governance and legal professionals, is to keep you abreast of the industry’s latest regulatory updates and provisions. Our areas of research focus include financial services, payment processing, workplace safety, and back office refresh.
Just as we set out to do when we first launched last year, this quarter – the first of 2022 – we aim ensure that you have all the latest information you need to do your job as efficiently as possible and with the utmost confidence.
We also include notations, where applicable, if the regulatory updates have been added to our IG and retention management software, Virgo, as a courtesy to active clients. We look forward to continuing to provide these updates throughout this year and beyond. Following is the latest on that front.
Canada – Clinical trial records for drugs and natural health products
- Effective February 11, 2022, Health Canada (department of the Government of Canada responsible for national health policy) reduced the period for keeping clinical trial records for drugs and natural health products from 25 years to 15 years. The new shorter period reflects clinical trial sponsors’ concerns about the cost and administrative burden the 25-year requirement placed on them.
- The period for keeping records starts on the date the record is created. To simplify the process, sponsors may choose to “start the clock” for keeping all study records when the trial is completed or terminated.
- The requirement to keep records for 15 years would apply to sponsors of:
- clinical trials of all drugs and natural health products authorized within the past 15 years
- any new clinical trials authorized as of the date of publication
- Citations in Virgo found under “CRC, c 870, s. C.05”
Spain – Keeping records of crypto advertisements
- The regulation of virtual assets and currencies are constantly evolving. We have seen a shift from cryptocurrency being largely unregulated or unrecognized to being considered an asset or security subject to regulation. On 17 January 2021, the Spanish Official State Gazette (BOE) published the new Circular 1/2022 of the National Securities Market Commission (CNMV) on the advertising of crypto-assets presented as investments.
- The Circular is aimed at developing the rules, principles and criteria to which crypto-asset advertising will be subject. It defines the types of entities and assets included in its scope and the powers granted to the CNMV, so it can supervise and control the advertisement of certain types of crypto-assets that have been deemed unregulated products thus far.
- These new rules apply to:
- Providers of crypto-asset services when they advertise crypto-assets
- Providers of advertising services
- Any natural or legal person not included in the previous two groups and that conduct activities related to crypto-assets, either on their own or through third-party delegation
- Among the requirements of the new rule is an obligation to keep records of advertisements published in the last 2 years. The CNMV may also require the suspension or correction of advertising campaigns that do not comply with the provisions of the Circular, notwithstanding the CNMV’s authority to apply penalties where appropriate, according to the laws applicable to each institution.
- These new rules apply to:
- Citation in Virgo found under “CNMV Circular 1/2022 of 10 January, r. 6”
Mexico – New guidelines for good manufacturing concerning medical devices
- After more than 10 years, the official standard of good manufacturing practices concerning medical devices has been updated. On December 20, 2021, the new version of the Official Mexican Standard NOM-241-SSA1-2021, Good medical device manufacturing practices, was published in the Official Gazette.
- The inclusion of the definitions of “software” as a medical device is of high relevance and solves the old loop in the regulation of software in connection with medical devices. Likewise, reference is made to the use of digital media, including digital records and the use of electronic signatures.
- This standard will leave NOM-241-SSA1-2012 without effect, until it enters into force in June 2023.
- Citations in Virgo found under “NOM-241-SSA1-2021, Art.”
United States – California increases retention period for personnel records
- Senate Bill 807 (SB 807), which makes procedural modifications to how the Department of Fair Employment and Housing (DFEH) enforces California’s civil rights laws, also expanded current record retention requirements.
- Effective January 1, 2022, employers must now retain “all applications, personnel, membership, or employment referral records” for 4 years from the date the records were created, or the date the employment action was taken.
- Prior to this amendment to Government Code section 12946, these records only needed to be kept for 2 years.
- In addition, SB 807 extends the period in which an individual can file a civil action for violations of certain statutes, by tolling that period while the DFEH investigates and/or takes action on a complaint. SB 807 also extends to two years the period of time that the DFEH has to complete its investigation and issue a right-to-sue notice for employment discrimination complaints treated by the DFEH as a class or group complaint.
- Citation in Virgo found under “CAL. GOV’T. CODE § 12946(a)”
To learn more about how to address records retention, data privacy and security requirements, request a Virgo demo here.