Rules Are Changing for Companies Wishing to Sell to U.S. Government

This article was originally posted on Mammoth Health’s website

By Dan Wasserman,  Innovator and Founder of Mammoth HealthInnovation

Health IT companies targeting U.S government regulatory agencies have recently been given a boost and are now on an equal footing with aerospace, defense and security providers. That’s good news for Canadian companies seeking to sell into the lucrative U.S. market.

On August 1, 2016, the US General Services Agency (GSA) added a new Special Item Number (SIN 132-56) to Schedule 70, the schedule covering Information Technology. This addition specifically lists six health-IT areas: electronic health records, mobile and telehealth technology, cloud-based services, medical sensors, remote monitoring devices, and assistive technologies.

The GSA forecasts $31.3 billion will be spent on health IT in 2017, with much of that by the US government.

Being listed on the GSA Schedule opens up government departments and agencies as new market opportunities beyond the traditional hospital groups, insurance companies, long-term care facilities, large medical practices, etc., often with larger contracts.

In the past, listing was arduous. But the GSA’s new FASTlane process cuts the typical 110-day process down to 45 days.

This includes such entities as the National Science Foundation (NSF), Social Security, the Veterans Administration (VA), and under Health and Social Services (HHS), the CDC, FDA, NIH, and CMS.

Plus, under the Trade Agreement Act (TAA) Canadian companies can qualify for a listing. Typically, Canadian health innovators target American private institutions either to overcome the heavy procurement limitations in Canada or as their first export market. With this change they have an even greater potential customer base in the US.

However, there are 123 other countries covered by the Act and these include such heavy-hitters as Ireland, Israel, Taiwan, and the UK. Innovative companies from all of these nations are expected to list. But if that isn’t enough of an impetus to get on the schedule, one only needs to look at the upcoming American election.

Should Donald Trump win and execute his threat to tear up the existing trade agreements, only grandfathered companies will remain. As for Hillary Clinton becoming the next president, by waffling on TPP it is unclear just what her policies will be.

In the past, the listing process was arduous and time-consuming. However, the GSA’s new FASTlane will cut the typical 110-days down to 45-days. That means there are effectively three approval cycles between August 1, 2016 and January 20, 2017, when the new president is sworn in.

Additionally, some Canadian innovators will benefit from the elimination of the two-years in business rule that has been replaced by project experience. There are specific requirements for approval under this change. However, for companies that have a track record the pathway is much clearer and using an experienced consultant smooths the process.

Having spent over 11 years in Washington, DC, with eight years of US government procurement, Mammoth Health Innovation immediately identified the magnitude of the GSA announcement for Canadian healthcare IT companies. We also recognized what a Health Economic and Commercial Impact Study (HECIS) meant for earlier stage companies’ ability to meet the new standard. However, for those already likely to qualify we have the expertise to immediately prepare a submission.

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Dan Wasserman is President of Mammoth Health Innovation. He can be reached at:

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