Healthcare News & Insights

Does HIPAA’s breach notification have a too-large loophole?

Broader HIPAA rules that just went into effect have a loophole that could hurt health care privacy efforts, according to some experts.

Among other changes, under the new rules, individuals have to be notified of breaches such as unauthorized access, or the release of protected information. But the rule has an exemption for encrypted data — notification is only required if the breach posed a significant risk of personal or financial harm.

Some experts worry that leaves providers with too much wiggle room to ignore some HIPAA breaches as long as they aren’t deemed of “significant risk.”

What are your thoughts? Is the rule a way to give providers working in good-faith a break on minor violations — or is it a HIPAA horror story waiting to happen? Sound off in the comments.

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Comments

  1. Darcy Gilson says:

    It is my understanding that HIPAA was introduced to avoid employers from getting medical records prior to hiring someone and discriminating based on HIV, cancer, etc. I personally consider this intent noble and just.

    The problem with the introduction of HIPPA as I see it is two-fold. The first being that the law is so poorly written few prosecutors are willing to press charges and go to trial to enforce this. If we look at how many convictions have been obtained under HIPPA it will tell the story.

    The second problem is that the law has created a new business that has added substantial cost to an already overburdened healthcare system. Hospitals hiring HIPAA experts, providing training, instituting forms and processes, and often firing physicians based on elevator conversations are only some of the far reaching and costly results that have stemmed from the introduction of this law. This is a far cry from the intent of this legislation.

    There will always be individuals that will try to use medical info. to their benefit, just as those who have exploited HIPPA to create fear and necessity to hire specialists, etc. Changing the law to allow encrypted data public will not address any of these problems.

  2. I agree that this is a good solution to the issues. If you are doing the right thing and working in good-faith you should not have to have the press, gov’t and every other media avenue reporting an incident. I believe it covers the intent of the regulation and should not be expanded futher.

  3. Michael Hagerty says:

    Congress has already weighed in on this, sending a letter to HHS on October 1st, 2009:

    The Honorable Kathleen Sebelius
    Secretary
    United States Department of Health and Human Services
    200 Independence Avenue, SW
    Washington, DC 20201

    Dear Madam Secretary:

    We are deeply concerned about the high bar that the Department of Health and Human
    Services (HHS) has set for notification of individuals in the case of an unauthorized use or
    disclosure of personal health information in its August 24, 2009 interim final regulations on
    Breach Notification for Unsecured Protected Health Information promulgated pursuant to the
    American Recovery and Reinvestment Act of2009 (ARRA). This is not consistent with
    Congressional intent.

    ARRA included provisions promoting health information technology (HIT) as a
    foundation for quality and efficiency improvements in the U.S. healthcare system. However,
    these benefits can be fully realized only with the inclusion of strong safeguards that protect the
    privacy and security of individuals’ personal health information. To gain the public trust, it is
    imperative that there is effective implementation of those provisions by HHS.
    Section 13402 of ARRA requires health care entities to notify individuals if there is an
    “unauthorized acquisition, access, use, or disclosure of protected health information which
    compromises the security or privacy of such information.” In its interim final rule, HHS
    interpreted the term “compromises” to include a substantial harm standard. If the breaching
    entity decides there is no significant risk of financial, reputational or other harm to the
    individual, that provider or health insurer never has to notify their patients that their sensitive
    health information was used or disclosed in violation of the federal privacy rule.
    ARRA’s statutory language does not imply a harm standard. In drafting Section 13402,
    Committee members specifically considered and rejected such a standard due to concerns over
    the breadth of discretion that would be given to breaching entities, particularly with regard to
    determining something as subjective as harm from the release of sensitive and personal health
    information.

    In fact, during development towards final policy, the Committee on Energy and
    Commerce released a discussion draft of health information technology and privacy legislation in
    May of 2008. In that draft, in addition to a definition of breach similar to that used here, the
    language specifically included a harm standard that was later rejected. The discussion draft only
    required,patients to be notified if the unauthorized use of personal health information could
    “reasonably result in substantial harm, embarrassment, inconvenience or unfairness to the
    individual.”

    Members considered the comments they received, the practices of States, and ultimately
    decided against inclusion of a harm standard. Instead, Members reported and passed legislation
    that has a black and white standard for notification with a safe harbor for information that is
    rendered unusable, unreadable, or indecipherable to unauthorized individuals, and other specific
    exceptions. The primary purpose for mandatory breach notification is to provide incentives for
    health care entities to protect data, such as through strong encryption or destruction
    methodologies and to allow individuals to assess the level of unauthorized use or disclosure of
    their information. Such transparency allows the consumer to judge the quality of a health care
    entity’s privacy protection based on how many breaches occur, enabling them to choose entities
    with better privacy practices. Furthermore, a black and white standard makes implementation
    and enforcement simpler.

    We urge HHS to revise or repeal the harm standard provision included in its interim final
    rule at the soonest appropriate opportunity. We hope to work more closely with the agency on
    future privacy regulations and request this letter be submitted as part of the official comments
    (reference number RIN 0991-AB56). Thank you for your ongoing commitment and attention to
    protecting Americans’ health information privacy.

    Sincerely,
    Henry A. Waxman
    Chairman
    Committee on Energy and Commerce

    Charles B. Rangel
    Chairman
    Committee on Ways and Means

    John D. Dingell
    Chairman Emeritus
    Committee on Energy and Commerce

    Frank Pallone, Jr
    Chairman, Subcommittee on Health
    Committee on Energy and Commerce

    Pete Fortney Stark
    Chairman
    Subcommittee on Health
    Committee on Ways and Means

    Joe Barton
    Ranking Member
    Committee on Energy and Commerce

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