Cash & the Legislation: Laws on over-the-counter listening to aids nonetheless awaited | Enterprise

Back in August 2017, Congress passed the Food and Drug Administration’s Reauthorization Act in a remarkable (these days) bipartisan effort. Among other things, this law instructed the FDA, an agency of the Department of Health, to establish a class of hearing aids that can be bought over the counter, such as toothpaste.

The FDA was given until August 18, 2020 to issue a draft ordinance to implement the law. This regulation should provide adequate guarantees of safety and effectiveness; Set output limits and labeling requirements; and otherwise establish rules for how over-the-counter hearing aids are sold in-store, by mail, or online. The FDA should issue a final ordinance no later than six months after the draft ordinance is drafted. But it is now September 12, 2021; There is no such regulation, and the FDA blaming COVID has apparently left the project behind.

This failure by the FDA to fulfill a clear mandate from Congress despite COVID has disheveled some feathers. Last November, two senators who supported the 2017 hearing aid legislation, Elizabeth Warren and Charles Grassley, then head of the FDA, wrote a letter asking him to do what Congress told his agency – to pass the ordinance . The senators said, “Hearing difficulties are linked to depression and dementia and increase the risk of falls in older adults.” In addition, hearing aids are expensive as prescription products and are usually not covered by health insurance.

Then, on July 9th of that year, the Biden government issued a far-reaching executive order directing all government agencies to get to work to create a competitive marketplace that is “critical to maintaining America’s role as the world’s leading economy ” is. This implementing ordinance contained an instruction to the Secretariat for Health and Social Affairs to issue the ordinance on over-the-counter hearing aids required by the 2017 law within 120 days (by November 6). So we’ll see what happens.

Of course, a delay in the availability of over-the-counter hearing aids doesn’t disappoint. In Colorado and elsewhere, licensed hearing aid manufacturers and audiologists benefit from a prescription marketplace and may need to adjust their business models if they compete with companies like Amazon.

Until over-the-counter hearing aids become a reality, some people with hearing problems may receive help from a “personal sound amplification device”. These are usually low-tech products that work on the same principle as turning up the volume on your TV, and they are not allowed to be called hearing aids. However, they can be purchased without a prescription and are much cheaper than real hearing aids.

In the event that older readers are wondering about this, despite careful research, I have not yet found anything in the law that prohibits hearing aid sellers from knowing your age and informing you after your 60th birthday.

Jim Flynn works for Flynn & Wright LLC in Colorado Springs. You can reach him at moneylaw@jtflynn.com.

Adjustments to AML and Digital Foreign money Laws for Reporting Entitles and Cash Service Companies | Bennett Jones LLP

Companies dealing with “virtual currencies” Monetary services company (MSBs) and others Reporting units (REs) to the Canadian Financial Transaction and Reporting Analysis Center (FINTRAC) are subject to new compliance obligations regarding transfers of virtual currencies over CAD 10,000 and keeping KYC (know-your-client) records as an update of the proceeds of The Act on Crime (Money Laundering) and Terrorist Financing (PCMLTFA) and related regulations come into effect on June 1, 2021

As of 2020, MSBs must:

  1. report suspicious Monetary transactions; and
  2. Do another KYC check when converting or transferring money according to regulations.

With effect from June 1, 2021, the above obligations of MSBs extend to transactions in virtual currencies. MSBs are also required care for and Submit Transaction records for transfers of virtual currencies over C $ 10,000 in a single transaction or over C $ 10,000 over several transactions within 24 hours (large VC transactions) and report these large VC transactions to FINTRAC.

In addition, the following KYC obligations will be expanded to apply to all REs:

  1. Business relationships: All REs must determine when a business relationship was established with a customer and keep a record of such business relationships.
  2. Politically exposed people: All REs must determine if customers are “Politically Exposed Persons” and conduct additional risk assessments in relation to those customers.
  3. Advantageous possession: All REs are required to keep records of a company and verify its identity, collect information on ownership, control structure and names of directors.
  4. Ongoing monitoring all KYC information from all REs.

background

The above changes are part of a broader multi-tiered overhaul of the AML regulatory framework aimed at addressing new challenges caused by the emerging cryptocurrency industry in Canada and are in line with aspects of the Canadian Securities Administrator Three year business plan Modernize the regulatory regime for crypto trading and crypto assets in Canada.

The first major revision came into force on June 1, 2020, whereby persons or organizations that “trade in virtual currencies” are required to register as MSB with FINTRAC. This means that those currently engaged in virtual money transfer or exchange services had to already be registered as MSBs. MSBs have ongoing reporting, record keeping, KYC and compliance requirements. The upcoming changes are designed to ensure that the activities of new MSBs from the first update are captured under the general obligations of all MSBs, and to harmonize the ongoing obligations of REs to transactions in virtual currencies in addition to traditional monetary transactions.

As of June 1, 2021, “virtual currency” will be defined in the provisions on the reporting of income from crime (money laundering) and terrorist financing (SOR / 2001-317) as well as in the provisions on income from crime (money laundering) and terrorist financing as follows:

(a) a digital representation of value that can be used for payment or investment purposes that is not fiat currency and that is easily exchangeable for Funds or any other virtual currency that is easily exchangeable for Funds; or

(b) a private key of a cryptographic system that enables a person or organization to access a digital representation of value in accordance with paragraph (a).

Applicable companies trading virtual currencies should take steps to ensure that they will be able to comply with the rules when they go into effect. The Bennett Jones Fintech and blockchain team can advise and support you in managing these and other changes to the crypto regulatory regime.

Remarks:

1. See https://canadagazette.gc.ca/rp-pr/p2/2019/2019-07-10/html/sor-dors240-eng.html and https://canadagazette.gc.ca/rp-pr/p2/2020/2020-06-10/html/sor-dors112-eng.html for the full text of the changes.