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Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Daniel Gottlieb ordered by Published Date Descending.
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Questions Remain For The EHR Industry As A Second EHR Vendor, Greenway Health, Settles False Claims Act Allegations
On February 6, 2019, the DOJ announced a settlement agreement with Greenway Health, a vendor of EHR software, under which Greenway agreed to pay approximately $57 million
United States
7 Mar 2019
2
False Claims Act Settlement With eClinicalWorks Raises Questions For Electronic Health Record Software Vendors
On May 31, 2017, the US Department of Justice announced a Settlement Agreement under which eClinicalWorks, a vendor of electronic health record software, agreed to pay $155 million and...
United States
20 Jun 2017
3
Required Exploration Of Telehealth Solutions
The massive 21st Century Cures Act specifically calls out telehealth as a potential means of delivering safe, effective, quality health care services to Medicare beneficiaries, . . .
United States
6 Feb 2017
4
Health Information Technology And Digital Health Tool Provisions
The 21st Century Cures Act includes provisions relating to health information technology (HIT) and related digital health initiatives, specifically in title IV.
United States
3 Feb 2017
5
21st Century Cures: Required Exploration Of Telehealth Solutions
President Obama signed the 21st Century Cures Act on December 13, 2016. The act encourages biomedical research investment and facilitates innovation review and approval processes...
United States
21 Dec 2016
6
End Of Year Attention To Health IT And Digital Health Tools In 21st Century Cures
The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle...
United States
20 Dec 2016
7
21st Century Cures: Health Information Technology And Digital Health Tool Provisions In Title IV
The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes...
United States
20 Dec 2016
8
OCR Explains How Information Blocking Violates HIPAA
The HHS OCR posted guidance clarifying that a business associate generally may not block or terminate access by a covered entity customer to PHI maintained by the vendor on behalf of the customer.
United States
27 Oct 2016
9
FDA Releases Draft Guidance On Postmarket Management Of Cybersecurity In Medical Devices
On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance).
United States
28 Jan 2016
10
OCR Enforcement Trends
On April 27, 2015, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a resolution agreement with Cornell Prescription Pharmacy.
United States
8 Jul 2015
11
OCR Transmits Pre-Audit Screening Surveys To Covered Entities For Phase 2 HIPAA Compliance Audits
The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently transmitted HIPAA pre-audit screening surveys to covered entities that may be selected for a second phase of HIPAA compliance audits (Phase 2 Audits).
United States
11 May 2015
12
FDA Issues Draft Guidance On General Wellness Devices And On Medical Device Accessories
Stakeholders should consider submitting comments to the FDA regarding the draft guidance documents.
United States
5 Feb 2015
13
OCR To Begin Phase 2 Of HIPAA Audit Program
The following sections summarize OCR’s Phase 1 Audit findings, describe the Phase 2 Audit program and identify steps to take to prepare for the Phase 2 Audits.
United States
30 Jul 2014
14
OCR Issues Final Modifications To The HIPAA Privacy, Security, Breach Notification And Enforcement Rules To Implement The HITECH Act
On January 25, 2013, the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) published a final rule.
United States
27 Feb 2013
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