HIT Consultant

SEPTEMBER 28, 2023

While well-intentioned, the Federal Government’s 2011 Meaningful Use Mandate program—to incentivize physician practices to adopt EHRs—did not specify detailed standards for EHR systems. This ultimately sets providers up to have more ownership and accountability in the care delivery decisions and to operate at the high end of their license.

Licensing 98

Licensing Hospitals 98

Innovaare Compliance

JANUARY 15, 2024

6] A compound drug not approved by the FDA under a New Drug Application or Biological License Application does not meet the definition of an applicable drug and will not be eligible for Part D. 3] Over several years, the “donut hole” or coverage gap for Part D has been closing since 2011. [4] Rebates from the selected drugs may change.

Medicare 52

Medicare Medicare Compliance FDA 52

The Health Law Firm

MAY 24, 2012

A Florida cardiologist recently had his medical license emergently suspended by the Florida Department of Health (DOH) for performing stem cell treatments. According to the emergency suspension order (ESO), the DOH had previously warned the doctor to stop performing these treatments in 2011. To view the ESO click here.

Licensing 40

Licensing Doctors 40

New Jersey Healthcare Blog

JANUARY 12, 2022

This notice extends the waiver of the continuing education requirements for current active health officers and REHSs who are renewing their license for the 2022 licensing period. The rules include definitions for various levels of supervision and permitted tasks within the scope of the license. See N.J.A.C. 10:101 as N.J.A.C.

Licensing 40

Licensing Medicaid Medicaid Nurses 40

Healthcare IT News - Telehealth

DECEMBER 7, 2022

"After assessing options, which at the time Children's Mercy began this initiative, in 2011, were very limited, it was decided that InTouch Health, a division of Teladoc Health, offered the best telemedicine platform to support regional telemedicine outreach clinics," Waller recalled.

Telemedicine 123

Telemedicine Nurses Licensing Hospitals 123

HIPAA Journal

JULY 15, 2023

HIPAA Guidelines: Seven Elements For Effective Compliance In 2011, HHS published “The Seven Fundamental Elements Of An Effective Compliance Program”. Please use the form on this page to arrange to receive a free copy of the HIPAA Guidelines Checklist. We have slightly amended it to be more relevant to HIPAA compliance in 2023.

HIPAA 84

HIPAA Compliance Compliance Officers Licensing 84

HIPAA Journal

NOVEMBER 17, 2022

Affected individuals visited Dr. Marilao between 2010 to 2011, had a last name starting with A through M, and either the parent or child was insured under a Medi-Cal or an HMO plan. Dr. Marilao said all files have now been moved into the offices upstairs, and new security cameras and alarms have been fitted.

Ransomware 82

Ransomware Health Insurance Hospitals Fraud 82

The Health Law Firm

JULY 5, 2012

The First District Court of Appeal heard the case and filed an opinion in favor of the ALFs on November 30, 2011. The amended final order revoked the ALFs' licenses, denied their licensure renewal applications, and imposed administrative fines. To view the opinion, click here.

Licensing 40

Licensing 40

Hall Render

FEBRUARY 14, 2023

The three policy statements include, Department of Justice and FTC Antitrust Enforcement Policy Statements in the Health Care Area (Sept. 15, 1993); Statements of Antitrust Enforcement Policy in Health Care (Aug.

Hospitals 45

Hospitals Health Care Access Licensing Medicare 45

Health Law Advisor

FEBRUARY 8, 2023

2011 Statement The Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in Medicare Shared Savings Program draws heavily on the 1996 Statement and provides a safety zone for those entities operating an ACO within the CMS Shared Savings Program.

Medicare 52

Medicare Medicare Hospitals Licensing 52

SQA

FEBRUARY 15, 2023

” The reason: The existing document of the EU GMP Guideline dates back to 2011 and no longer corresponds to the state of the art in various areas or does not consider increasingly important new technologies for the GMP field, according to the EMA. ” The requirements for providers (e.g.,

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

Verisys

JULY 13, 2023

Verisys’ former VP of Pharma and Pharmacy Solutions, Joe Thompson, shared a prime example of how speaker programs introduce risk to the pharmaceutical company: “In 2011, one of the most prominent endocrinologists in my sales region was an active speaker for my previous company. He led multiple programs for us each year.

Compliance 52

Compliance Due Diligence Pharmaceutical Industry Fraud 52

Healthcare Law Blog

JANUARY 10, 2022

Finally, plans would be required to ensure that TPMOs conducting lead generating activities must inform the beneficiary that his or her information will be provided to a licensed agent for future contact, or that the beneficiary is being transferred to a licensed agent who can enroll him or her into a new plan.

Medicare 98

Medicare Medicare COVID-19 Medicaid 98

Health Law Advisor

AUGUST 10, 2023

FDA specifically identified the following as not having to register as device manufacturers: Licensed practitioners, including physicians, dentists, and optometrists, who manufacture or otherwise alter devices solely for use in their practice. [8] 8] We could go on, but hopefully you get the gist.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

DECEMBER 10, 2021

Kerela Ayurvedic & Natural Herbal Consultation was also found to be operating without a Health Canada site license. This document is a consolidation and revision of IPEC Europe’s GDP Audit Guideline (2011) and IPEC-Americas GDP Audit Guide for North American Distribution of Pharmaceutical Excipients (2011).

FDA 52

FDA Compliance Public Health Hospitals 52

Drug & Device Law

MAY 19, 2023

at *1, by threatening to revoke the license, and jail for at least three years, any West Virginia physician so bold as to prescribe the plaintiff’s FDA-approved drug for its FDA-approved use.

FDA 111

FDA Medical Personnel Telemedicine Licensing 111

Drug & Device Law

JULY 31, 2023

2011 WL 13186258, at *2 (C.D. May 17, 2011) (flight simulator and associated training materials were not products subject to strict liability); Heindl v. Wells Fargo Bank , 2011 WL 1833020 (D. May 13, 2011), applied Birmingham to hold that financial transactions were not “products” to which strict liability could apply.

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. OTC drugs also have an express preemption provision, but it contains an exception for Prop 65.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . Johnson & Johnson , 2011 WL 3876997 at *11 (S.D. 31, 2011), aff’d , 483 Fed. 909 (5th Cir.

Doctors 59

Doctors Licensing Informed Consent Hospitals 59

Drug & Device Law

MAY 26, 2023

2011), aff’d , 741 F.3d You never need an authorization from a licensed professional to buy pork or fireworks. As one district court put it, it was “aware of no state law duty that would compel generic manufacturers to stop production of a drug that under federal law they have the authority to produce.” See Gross v. Pfizer, Inc. ,

FDA 59

FDA Licensing Doctors Governance 59

Drug & Device Law

FEBRUARY 20, 2023

223, 238 (2011), the United States Supreme Court reacted to a plaintiff’s unconstrained claims of “alternative” vaccine design: [T]he [design] decision is surely not an easy one. In Bruesewitz v. Wyeth LLC , 562 U.S. As a result, appellee was prohibited by federal law from employing either of these [alternatives]. Wyeth Laboratories, Inc. ,

FDA 59

FDA Licensing Hospitals Governance 59

Drug & Device Law

NOVEMBER 9, 2023

552 (2011); Thompson v. Now: The term health care providers (HCPs) refers to individuals such as physicians, veterinarians, dentists, physician assistants, nurse practitioners, pharmacists, or registered nurses who are licensed or otherwise authorized by law to prescribe, order, administer, or use medical products in a professional capacity.

FDA 64

FDA Health Insurance Nurses Medicare 64

Drug & Device Law

OCTOBER 27, 2022

From this, the court concluded the defendants could “comply with both federal and Illinois law by obtaining proof of identity and establishing a donor identification system using photographic identification, a valid driver’s license, or any other non-biometric means.” The court read the preamble differently. But, under Geier v.

FDA 59

FDA Licensing Compliance 59

Drug & Device Law

MAY 9, 2022

Grady involved a small plane crash, and the plaintiff sued (among others) the flight school that had provided the pilot with the “aerial practicum required prior to obtaining a private pilot license” and several individual instructors. 2011), aff’d , 816 N.W.2d White , 692 A.2d 2d 902, 905 (Del. 1997); Waugh v. 2d 540, 553-54 (Ill.

Malpractice 59

Malpractice Licensing 59

Drug & Device Law

MARCH 7, 2022

2011 WL 2149095, at *5 (N.D. May 31, 2011). “[I]n It does not give him license to evade the less rigid ? 2011), and Fowler v. It does not, however, give a plaintiff “license to evade the less rigid ? 2011) – notable because it is also from a Third Circuit-bound court. March 18, 2011), and Allegrino v.

Fraud 59

Fraud FDA Licensing Pharmaceutical Industry 59

Drug & Device Law

FEBRUARY 19, 2024

That regulation provides that a prescription-only drug – one that can only be obtained through “a practitioner licensed by law to administer or prescribe such drugs” bearing “[t]he statement ‘Rx only’” – is “exempt” from requirements to provide adequate directions for use to patients. For drugs, the relevant regulation is 21 C.F.R.

FDA 52

FDA Licensing 52