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container of the kit. In this example, some devices in the kit are intended by the labeler to be reprocessed and reused, and therefore those reusable devices are subject to direct mark requirements (21 CFR 801.45). Different devices that are packaged together for the convenience of the user, but the collection of devices is not itself a device: labeler manufactures uid-fi lled teething rings in a variety of shapes. The labeler packages one teething ring of each shape together as a fi ed uantity to cre- ate an item for retail with a higher profi t margin and/or to allow each end user to select and use a particular model of teeth- ing ring according to preference. This is not a convenience kit because the devices packaged together are not collectively a device. substituted, repackaged, sterilized, or otherwise processed or modifi ed before the devices are used by an end user. FDA link:
https://www.fda.gov/ regulatory-informationsearch-fda- guidance-documentsuniue-device- identifi cation-convenience-kits
First-ever agency collaborative report lists top-priority zoonoses for U.S. The enters for isease ontrol and reven- tion (CDC) and its U.S. government partners have released the fi rst federal collaborative report listing the top zoonotic diseases of national concern for the nited tates. oo- notic diseases are illnesses that can spread between animals and people.
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The CDC, U.S. Department of the Interior (DOI), and U.S. Department of Agriculture (USDA) developed the report after jointly hosting a ne ealth oonotic isease ri- oritization Workshop for the United States. During the workshop, agencies agreed on a list of eight zoonotic diseases that are of greatest concern to the nation and made recommendations for next steps using a One Health approach.
The zoonotic diseases of most concern in
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the .. are oonotic in uenza, almonel- losis, West Nile virus, Plague, Emerging coronaviruses (severe acute respiratory syndrome and iddle ast respiratory syn- drome, abies, rucellosis. and yme dis- ease.
Six out of every 10 infectious diseases in people are zoonotic, which makes it crucial that the nation strengthen its capabilities to prevent and respond to these diseases us- ing a One Health approach. One Health is an approach that recognizes the connection between people, animals, plants, and their shared environment and calls for experts in human, animal, and environmental health to work together to achieve the best health outcomes for all.
June 2019 • HEALTHCARE PURCHASING NEWS •
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HHS reduces the maximum penalties for HIPAA violations The Department of Health and Human ervices has modifi ed a civil mon- etary penalty (CMP) rule for violations of the ealth nsurance ortability and c- countability Act (HIPAA) by reducing the maimum fi nes healthcare providers would have to pay on nearly all infractions except the most severe. In 2009, congress passed the HITECH Act, as part of the American Recovery and reinvestment Act, to bolster HIPAA enforcement with higher minimum and maximum potential CMPs. Upon further review of the statute by
the ffi ce of the eneral ounsel, the agency said it had determined that a better reading of the HITECH Act of 2009, which categorizes culpability and penalties into four tiers, or types, is to apply annual limits on all three except for willful neglect without correction. Prior to the current change, all four tiers shared that same maximum penalty. illful neglect, without timely correc-
tion, will continue to have a maimum an- nual penalty of $1.5 million, while other, less serious breaches, have been reduced signifi cantly for an unspecifi ed duration.
Setting a new paradigm for pain management The Pain Management Best Practices nter-gency Task orce, established in 2016 by the Department of Health and uman ervices to address gaps or incon- sistencies for managing chronic and acute pain with updates to best practices, held a meeting ay -, to discuss new recommendations for pain management. The objective is to advance policies to end the opioid crisis while balancing the treatment needs of patients suffering with legitimate pain. Among the task force recommendations:
bolstering support for multidisciplinary, multimodal approaches to treating pa- tients with acute and chronic pain;
reversing harmful policies such as arbitrary limits on prescribed pain medications;
providing individualized treatment that accounts for co-morbidities and severity, not one-size-fi ts-all approachesa point emphasized last week by the Centers for Disease Control and Prevention;
encouraging better health insurance coverage of affordable, evidence-based non-opioid medications and non-pharma- cologic treatments for pain and eliminat- ing obstacles to treatment such as fail-fi rst policies; and recognizing the urgent need to address stigma as a barrier to care. HPN
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