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What happens when regulators become implementers?

A lot of people have asked me why there are no standards for health information in the Philippines*. This is a tricky question and one that does not have a right or wrong answer. But allow me to re-phrase it as follows: what happens when regulators (those who impose standards) are also implementers of those standards?

Let’s look at the positive side. We can almost be sure the implementations will be according to the regulations/standards they have formulated. There will be no question about compliance. But this sunny option presumes the standards were in place before they were implemented.

On the downside, the problem occurs when the (regulator’s) implementation comes _before_ the standards are defined. More often than not, the implementation is not compliant (as it preceded the standard). The implementer-regulator then finds itself in a tight fix. The implementer-regulator has three possible options:

1) Keep the status quo. Don’t publish anything. This way the implementation is off radar, and can continue to exist. It’s not standard, but who cares? There is no standard anyway. (Anticipate health informatics chaos here to the same degree America finds itself now.)

2) Make the implementation the standard. This option is too strong, and it won’t hold scrutiny in public. The standards definition process has to be participatory and coming out with the standard (through the implementation) at the outset diminishes its potency. This option is too dictatorial it only serves to highlight the imperfection of the implementation rather than the benefits of having standards.

3) Make pronouncements about the ideal standard (based on evidence), and bite the bullet that the existing implementation may need to be overhauled or even decommissioned. It is also entirely possible to forego the business of implementation and shift to testing and certification (it might actually be more lucrative for the regulator).

Whatever the regulator chooses, there is a huge lesson for all of us here: regulators should not be implementers. Regulators should define the standards and provide tests/certification for implementations. Once regulators become implementers, the check and balance is lost.

And the country will not have the standards it direly needs. In the year 2009.

* There was an attempt in 1999 to publish standards for health information in the Philippines. The UP Manila-NIH facilitated that effort together with the DOH, PHIC, PHA, PMA, and other major professional organizations. In retrospect, a standard has to be implemented to become part of civil society. A theoretical standard (like this 1999 document) is useless without reference implementations.

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