HIT Consultant

NOVEMBER 21, 2021

“Electronic Health Information,” ONC’s new term for the data elements that need to be “exchangeable” upon request, is currently limited to data elements within the U.S. 6, 2022, the definition will expand to the electronic designated record set defined under HIPAA. Core Data for Interoperability ( USCDI ) standard.

Compliance 98

Compliance Public Health HIPAA Governance 98

New Jersey Healthcare Blog

JULY 7, 2021

700(b), the Health Department, Division of Certificate of Need and Licensing, Certificate of Need and Healthcare Facility Licensure Program, adopted several amendments and a new rule addressing hospice licensing standards and patient care services. Several changes were made to the Hospital Licensing Standards.

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Licensing Nurses Public Health Hospitals 40

Health Law Advisor

SEPTEMBER 12, 2023

The DEA has the final authority to reschedule a drug and will now initiate its own review of marijuana, a process that does not have any definitive timeline but could be moved along if determined to be an agency priority. A DEA spokesperson confirmed the department had received the letter with HHS’s recommendation.

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FDA Licensing Public Health 111

New Jersey Healthcare Blog

JULY 7, 2021

are waived for the duration of the Public Health Emergency, as long as one quarter of the facility’s reporting cycle is covered by the Public Health Emergency; and. Physician volume utilization requirements are waived for any calendar year that the Public Health Emergency was in effect for 90 days or more.

COVID-19 40

COVID-19 Licensing Public Health Nurses 40

New Jersey Healthcare Blog

MARCH 8, 2022

203(a), the Office of the Governor issued Executive Order 280 declaring that a Public Health Emergency, established in Exec Order No. d), to permit the Committee to count clinical hours obtained before the submission of the proposed plan of supervision toward the number of supervised hours required to become a licensed counselor.

Telemedicine 40

Telemedicine COVID-19 Licensing Nurses 40

Hall Render

MAY 17, 2023

The Proposed Rule would modify that definition to refer to “an individual or entity, other than a health care provider that self-develops health IT not offered to others , that develops or offers health information technology,” and has one or more modules certified under the ONC Health IT Certification Program.

Licensing 40

Licensing Public Health Governance 40

New Jersey Healthcare Blog

OCTOBER 12, 2021

1440(a), the Department of Health, Public Health Services Branch, Division of HIV, STD, and TB Services, proposed recodification, amendments, new rules, and repeals. The amendments address spelling and language changes, as well as definitional changes and additions. On September 7, 2021, at 53 N.J.R. See N.J.A.C.

COVID-19 40

COVID-19 COVID-19 Vaccine Licensing Hospitals 40

Hall Render

DECEMBER 30, 2022

This revised framework includes CPT code definition changes, including without limitation: New descriptor times; Revised interpretive guidelines for levels of medical decision-making; Choice between medical decision making or time to select code levels; and.

Medicare 40

Medicare Medicare Licensing Health Services Administration 40

New Jersey Healthcare Blog

MARCH 3, 2021

Ambulatory care facilities operating mobile vans may implement the terms of this waiver as necessary until the conclusion of the Public Health Emergency declared by Governor Philip D. 102 (a), the Department of Health published a notice of emergency adoption of a temporary rule waiver/modification of N.J.A.C. See N.J.A.C.

Nurses 40

Nurses Licensing Hospitals Public Health 40

Healthcare Law Blog

MAY 16, 2022

CMS also advises the Final Rule will equip MAOs with the “person-level information” that will help them better connect people to covered services, social service organizations, and public programs that can help resolve housing instability, food insecurity, or transportation challenges. and 422.107).

Medicare 52

Medicare Medicare Medicaid Medicaid 52

Innovaare Compliance

OCTOBER 6, 2022

MAOs have to ensure that TPMOs use a standardized disclaimer in their marketing materials that meet the definition of marketing whether they are in print, on the website, or in television advertising. New third-party marketing organization (TPMO) oversight requirements will go into effect on October 1, 2022.

Medicare 52

Medicare Medicare Compliance Public Health 52

Bill of Health

AUGUST 29, 2022

Legally speaking, patent pledges are comparable to the open source software licenses that underlie much of the world’s technology infrastructure and the Creative Commons licenses that make billions of online images, videos and other content freely available (both discussed here ). Tesla and Toyota) to software (e.g, see Jacobsen v.

COVID-19 Vaccine 362

COVID-19 Vaccine COVID-19 Licensing Governance 362

Hall Render

JUNE 5, 2024

In April 2024, the Food and Drug Administration (“FDA”) issued a Final Rule amending the definition of in vitro diagnostics products (“IVDs”) found in 21 C.F.R.

FDA 40

FDA Compliance Regulatory Compliance Licensing 40

New Jersey Healthcare Blog

JANUARY 12, 2022

Below are the most recent health care related regulatory developments as published in the New Jersey Register from October-December 2021: On October 4, 2021, at 53 N.J.R. 103, which declared a Public Health Emergency for the state in response to COVID-19. Definitions and 4.1, See N.J.A.C. 8:7-1.11, 1.12, 1.13, 1.17.

Licensing 40

Licensing Medicaid Medicaid Nurses 40

Healthcare Law Blog

JANUARY 26, 2023

The provisions also prohibit entities that receive federal funds from denying admission or discriminating against any applicant for training or study based on their reluctance or willingness to counsel, recommend, perform, or assist in certain health services or research activities because of their religious beliefs or moral convictions.

ACA 105

ACA Medicaid Medicaid Compliance 105

HIT Consultant

OCTOBER 6, 2021

It is true that licensed nursing agencies are available to take much of the burden off family caregivers, but the cost of such services is beyond the reach of many of those who need it most. Patients and their family caregivers, by definition, are “weaker” than their providers. More Can—and Must—Be Done. How does that make sense?

COVID-19 98

COVID-19 Doctors Health Outcomes Licensing 98

NY Health Law

FEBRUARY 13, 2024

Professional Technical Titles: This includes Physician Assistant, Licensed Mental Health Counselor, Master of Social Work, Credentialed Alcoholism and Substance Abuse Counselor, Certified Pharmacy Technician, Certified Medical Assistant, and Respiratory Therapist.

Medicaid 52

Medicaid Medicaid Nurses Medicare 52

AIHC

SEPTEMBER 5, 2023

Chat-Based (Asynchronous) - This approach is online or through a mobile app communication which transmits the patient’s personal health data, vital signs, and other physiologic data or diagnostic images to a healthcare provider to review and deliver a consultation, diagnosis, or treatment plan at a later time.

COVID-19 59

COVID-19 Telemedicine Compliance Informed Consent 59

AIHC

NOVEMBER 3, 2023

Diagnostic error, as defined by the National Academy of Medicine , is “ the failure to (a) establish an accurate and timely explanation of the patient’s health problem(s) or (b) communicate that explanation to the patient.” One of the major challenges in effectively deploying AI in health care is managing implementation and maintenance costs.

Department of Veterans Affairs 59

Department of Veterans Affairs Hospitals Compliance Nurses 59

C&M Health Law

JANUARY 4, 2024

Information Blocking Enhancements ONC has modified the information blocking regulations, which were adopted in May 2020 ( ONC Information Blocking Rule ), by a) revising the definition of the term “offer health IT”; and b) modifying the information blocking exceptions. public health emergency, war, natural disaster, etc.).

Public Health 52

Public Health Licensing HIPAA Governance 52

Healthcare Law Blog

OCTOBER 25, 2023

It remains to be seen whether subsequent regulations will further clarify the applicability of this law to certain individual roles that may not neatly fall within the Act’s definitions. An applicant will also need to satisfy certain prelicensure requirements and complete continuing education to maintain their license.

Licensing 52

Licensing Compliance FDA Public Health 52

Healthcare Law Blog

MAY 9, 2023

Applicability of Notice Requirements Pursuant to the new law, “health care entities” must provide written notice, with certain supporting documentation, of “material transactions” to the DOH. [1]

Licensing 52

Licensing Public Health Health Insurance Governance 52

Healthcare Law Blog

JANUARY 10, 2022

Refining Definitions for Fully Integrated and Highly Integrated D-SNPs (§§ 422.2 The obligation to comply with the special requirements would end 30 days after the latest of last disaster/emergency declaration is ended (whether state of federal) or there is no longer a disruption to access of health care. and 422.107).

Medicare 98

Medicare Medicare COVID-19 Medicaid 98

Healthcare IT Today

MAY 3, 2023

The excitement has been largely fueled by the renowned public health benefits of, and the seductive commercial opportunity for, a seamless hypertension management solution that is virtually invisible – part of what people are already wearing, such as smartwatches, earbuds, smart rings, and apparel.

FDA 108

FDA Public Health Licensing Telemedicine 108

New Jersey Healthcare Blog

JULY 22, 2022

509(a), Governor Murphy issued an Executive Order updating and clarifying timeframes for requiring covered workers at health care facilities and high-risk congregate settings to be up-to-date with their COVID-19 vaccinations, including having received a booster shot. On April 4, 2022, at 54 N.J.R. See Executive Order No. 290 (2022).

COVID-19 Vaccine 40

COVID-19 Vaccine Licensing COVID-19 Public Health 40

Hall Render

SEPTEMBER 1, 2023

ALABAMA American Family Care opens new health care center in Northeast Birmingham doctors secure $13.9M operating margin, $1B net gain halfway through its first year Illinois public health officials warn of “rising COVID-19 activity” St.

COVID-19 40

COVID-19 Nurses Nursing Homes Hospitals 40

Healthcare IT Today

JANUARY 9, 2024

Clinicians need to spend their 10-15 minutes in an exam room talking to patients, answering questions, and practicing at the top of their license. Within healthcare, the technology and expertise exist to help providers, payers, public health, health information exchanges, and healthcare IT companies exchange data.

Hospitals 107

Hospitals Regulatory Compliance Compliance Licensing 107

SQA

MAY 24, 2023

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

FDA 40

FDA Licensing Governance Compliance 40

Healthcare IT News - Telehealth

MARCH 30, 2020

The platform is being leveraged around the globe by public health departments, academic researchers, health systems and managed care organizations. GlobalMed also manufactures lightweight cameras and otoscopes for high-definition images and video. Teladoc Health. The company’s patients access its U.S.-based,

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COVID-19 Telemedicine Hospitals Doctors 218

C&M Health Law

FEBRUARY 1, 2022

Biologic-led combination products are reviewed under one of the two biologics license application (BLA) pathways under section 351 of the Public Health Service Act—either a section 351(a) BLA (a “stand-alone” BLA) or a section 351(k) BLA (for a biosimilar or interchangeable biological product).

FDA 52

FDA Licensing Public Health 52

SQA

SEPTEMBER 2, 2022

Borderline products must meet the MDR definition and scope of a medical device or accessory to a medical device to fall under the Regulation’s requirements. Products must meet MPD definitions of a medical product to meet 2001/83/EC requirements: Any substance or combination of substances with properties for treating or preventing disease.

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

SQA

DECEMBER 16, 2022

It will also facilitate cross-border circulation of these critical health therapies as well as cross-border cooperation between public health authorities. In addition to definitions of chromatographic features, the revision to General Chapter 2.2.46. General Chapter 2.2.28. Gas Chromatography (GC). General Chapter 2.2.29.

FDA 40

FDA Compliance COVID-19 Licensing 40

AIHC

JUNE 22, 2022

Many facilities and groups who are accredited by an entity, such as JCAHO, AAAHC, AAAASF (just to name a few), are REQUIRED to complete this process for every provider who is rendering services within the group or facility, especially active, licensed, independent practitioners, or LIPs.

Medicaid 52

Medicaid Medicaid Due Diligence Medicare 52

Hall Render

JANUARY 6, 2022

Staff Definition. This definition also includes individuals under contract or by arrangement with the facility, including hospice and dialysis staff, physical therapists, occupational therapists, mental health professionals, licensed practitioners, adult students, trainees or volunteers.

COVID-19 Vaccine 40

COVID-19 Vaccine COVID-19 Nurses Compliance 40

AIHC

OCTOBER 5, 2022

What remains clear is the lack of consensus on the definition. Other narrower definitions restrict it to images only. Being a fairly recent phenomenon, there is still much room for research on sexting and mental health. Some people use it to describe sending of the sexual content of any type.

Licensing 52

Licensing Public Health Compliance 52

SQA

DECEMBER 10, 2021

For the drug-device combination products whose attributes cannot be determined, the applicants shall apply for attribute definition to Center for Medical Device Standards Management, NMPA (CMDSM) prior to registration application. The Department will inform Canadians as needed, should any new health risks be identified.

FDA 52

FDA Compliance Public Health Hospitals 52

Health Law Advisor

AUGUST 10, 2023

4] This definition has been remarkably durable, because instead of focusing on a particular technology, it focuses on how products are intended to be used. 4] This definition has been remarkably durable, because instead of focusing on a particular technology, it focuses on how products are intended to be used. Very brief.

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FDA Licensing Hospitals Medicaid 98