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24 Aug 2020, 2:52 pm by Elizabeth G. Litten
This means that there are certain situations in which a health plan or health care provider that is a covered entity may use and/or disclose PHI of recovered COVID-19 patients to encourage them to donate plasma, and others in which it may not (without first getting the patients’ written HIPAA authorizations): Allowed:  a covered entity may use member or patient information to contact the covered entity’s own members or patients to encourage them to donate… [read post]
24 Aug 2020, 2:52 pm by Elizabeth G. Litten
This means that there are certain situations in which a health plan or health care provider that is a covered entity may use and/or disclose PHI of recovered COVID-19 patients to encourage them to donate plasma, and others in which it may not (without first getting the patients’ written HIPAA authorizations): Allowed:  a covered entity may use member or patient information to contact the covered entity’s own members or patients to encourage them to donate… [read post]
15 Aug 2020, 9:30 pm by Josh Blackman
I am less confident with this argument, but I do not think Congress can sidestep the Necessary and Proper Clause problems by shifting the onus onto regulated entities. [read post]
13 Aug 2020, 8:09 am by Lisa Larrimore Ouellette
RADx projects are assessed—and funded—in three phases: Phase 0, a basic concept and, possibly, a working prototype; Phase I, a validation study and a risk review assessment; and Phase II, clinical tests, regulatory approval, and a scale-up of manufacturing. [read post]
7 Aug 2020, 7:47 pm
  OEIGWG CHAIRMANSHIP SECOND REVISED DRAFT 06.08.2020 LEGALLY BINDING INSTRUMENT TO REGULATE, IN INTERNATIONAL HUMAN RIGHTS LAW, THE ACTIVITIES OF TRANSNATIONAL CORPORATIONS AND OTHER BUSINESS ENTERPRISES Preamble The State Parties to this (Legally Binding Instrument),Reaffirming the principles and purposes of the Charter of the United Nations; Recalling the nine core International Human Rights Instruments adopted by the United Nations, and the eight fundamental Conventions… [read post]
31 Jul 2020, 12:38 pm by Rebecca Tushnet
Registration rate initially declines w/# of entities opposing the application. [read post]
  In order to qualify, the affiliated group of entities collectively need to have either (i) 2019 annual revenues of $5 billion or less[iv] or (ii) no more than 15,000 employees. [read post]
9 Jul 2020, 3:35 pm by Kevin LaCroix
I would like to thank the authors for allowing me to publish their article as a guest post on this site. [read post]
8 Jul 2020, 4:32 pm by Sanjana
I am entirely unconvinced we are the only country to face this. [read post]
2 Jul 2020, 5:09 am by Jim Singer
A summary of each status is: Small entity: an entity that: (i) is a nonprofit organization; OR (ii)  does not, together with all affiliates, have 500 or more employees; AND has not assigned, licensed or otherwise conveyed an interest in the invention to a non-small entity. [read post]
8 Jun 2020, 10:13 am by Schachtman
Furthermore, there is the matter of physicians reading the same X-ray in two, inconsistent ways. [read post]
[i] In April, USDA announced an expansion of the meat packer price manipulation investigation it began last August. [read post]
2 Jun 2020, 10:35 am by Schachtman
” For particularity’s sake, GAF alleged, with extensive quotations from the Baron & Budd memorandum, that the memorandum told “witnesses to identify only those products listed on the Work History Sheets prepared by Baron & Budd (lest the witness identify the product of a bankrupt entity from whom no damages or attorneys’ fees could be collected). . . .and to memorize the product names provided by Baron & Budd on the “Work History Sheets” and… [read post]
If Rule 3-05 of Regulation S-X requires a registrant to provide separate financial statements for a business, then the registrant must also provide unaudited pro forma financial information related to the acquisition prepared in accordance with Article 11 of Regulation S-X. [read post]
26 May 2020, 12:19 pm by Daniel Fundakowski
Further, in the application the parent entity should “submit a statement on the first page of the uploaded tax return file stating (i) the parent entity’s Filing TIN and that it does not bill Medicare and (ii) a schedule of the billing subsidiaries, their Billing TINs, and gross sales or receipts. [read post]
22 May 2020, 3:00 am by John Jenkins
I suppose you’re wondering if the SEC split along partisan lines once again – well, of course they did! [read post]