Healthcare Law Blog

DECEMBER 15, 2022

The Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule , “Advancing Interoperability and Improving Prior Authorization Processes” (the “Proposed Rule”), that is intended to improve patient and provider access to health information and streamline processes related to prior authorization for medical items and services.

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Healthcare Law Blog

MAY 25, 2023

The Florida Legislature recently amended the Florida Electronic Health Records Exchange Act (the “Act”) to prohibit certain health care providers utilizing certified electronic health record technologies from storing qualified electronic health records [1] outside of the United States, its territories, or Canada. [2] 408.051(3).

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Health Care Law Brief

APRIL 12, 2023

Part C Reforms Pursuant to the Final Rule, if an MA plan prior authorized an item or service or made a pre-service determination of coverage or payment, the MA plan may not later deny coverage for lack of medical necessity and may not reopen the decision, except for “good cause” (as defined in 42 C.F.R. 79452 (2022)). 405.902).

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Health Law RX

DECEMBER 21, 2023

The electronic protected health information (ePHI) of approximately 206,695 individuals was affected. LMG was the victim of a phishing attack, a type of cybersecurity attack wherein individuals are tricked to disclose sensitive information via electronic communication.

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Healthcare Law Blog

FEBRUARY 1, 2023

If finalized, the Centers for Medicare and Medicaid Services (CMS) Proposed Rule on Advancing Interoperability and Improving Prior Authorization Processes will require payers to participate in electronic payer-to-payer data exchange and implement automated prior authorization processes.

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Hall Render

OCTOBER 5, 2023

The subject’s voluntary agreement to participate should then be obtained and documented prior to enrollment. Subjects must be made aware that the FDA may inspect records related to the investigation without the subject’s permission or authorization. study sponsor, regulatory agencies, etc.)

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Hall Render

APRIL 14, 2023

If the attestation is signed by a representative of the person requesting the information, a description of such representative’s authority to act for the person must also be provided. It may be obtained electronically as long as all required elements are present.

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MedTrainer

MAY 13, 2021

FAQ: Assessing Access and Accountability With Electronic Health Records (EHR). To ensure that the PMI that gets processed is not compromised through constant changes in the data management procedure, it’s vital that a higher authority does not overrule the CPO or CSO. Ensure Proper Access to PHI. Establish a Regular Audit Process.

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MedTrainer

MAY 13, 2021

FAQ: Assessing Access and Accountability With Electronic Health Records (EHR). To ensure that the PMI that gets processed is not compromised through constant changes in the data management procedure, it’s vital that a higher authority does not overrule the CPO or CSO. Ensure Proper Access to PHI. Establish a Regular Audit Process.

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Healthcare Law Blog

MAY 2, 2023

PACE Enforcement Authority for Civil Monetary Penalties and Intermediate Sanctions CMS clarified its enforcement authority for civil monetary penalties (“CMPs”) and intermediate sanctions (i.e., This provision is effective June 5, 2023. enrollment or payment suspensions) for PACE programs. To address this, CMS is amending § 460.70(a)

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Healthcare Law Blog

JANUARY 26, 2024

Reporting companies that are not exempt and were registered to do business with their applicable Secretary of State prior to January 1, 2024, have until January 1, 2025 to file their BOIR. 10] Companies can make the report electronically at BOI E-FILING (fincen.gov) by either submitting a pdf form or entering the information directly.

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Hall Render

MAY 2, 2023

In 2020, CMS issued an interim final regulation to require SNFs to electronically report to the CDC information about COVID in each SNF in a form specified by CMS through the National Healthcare Safety Network. Three-Day Prior Hospitalization/Qualifying Hospital Stay. COVID Reporting Requirements. Benefit Period Blanket Waiver.

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Total HIPAA

MAY 31, 2023

Some key provisions of the regulation include: Consent requirements: Prior written consent is generally required from patients for any disclosure of their SUD treatment records, except in limited circumstances specified by the regulation. Court orders must meet specific requirements to ensure patient privacy is protected.

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Exeed Regulatory Compliance

FEBRUARY 25, 2020

The second is that the regulatory framework is not evolving fast enough to facilitate timely marketing authorization of connected medical devices. The medical device should work correctly prior to delivery, during the integration process and continue to work while in use and through maintenance and release of software updates.

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Hall Render

DECEMBER 21, 2022

Some tracking technology vendors indicate that the information transmitted through the use of tracking technologies is filtered or de-identified prior to the vendor processing or storing such information. Disclosures of PHI through tracking technologies without a BAA require a HIPAA‑compliant authorization.

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HIT Consultant

MARCH 24, 2023

Today, cNLU is being applied to billing/coding, trial enrollment, registry creation, clinical decision support, prior authorization, fraud/abuse detections, and other labor-intensive workflows. To validate results, attend to the most difficult cases, and become more informed about their patients.

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Healthcare IT Today

JANUARY 2, 2023

Most Visited Healthcare IT Today Articles that were Published Prior to 2022. New Updates to HIMSS EMRAM (Electronic Medical Record Adoption Model). Are Blogs Still Worthwhile? New Updates to HIMSS EMRAM (Electronic Medical Record Adoption Model). Why Haven’t Payers Automated Prior Authorizations Previously?

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Health Law RX

JULY 18, 2023

Information Blocking Background In 2016, the 21st Century Cures Act (Cures Act) made sharing electronic health information (EHI) the new normal in healthcare, with the twin goals of encouraging and incentivizing the free flow of patient information among stakeholders and driving efficiencies in healthcare. See 42 U.S.C. 1320a–7a(d).

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Fraud Compliance Medicaid Medicaid 52

Health Law Advisor

JULY 5, 2023

Effective July 1, 2023, the State of Florida prohibits companies from: (i) selling “sensitive data” without receiving prior consent from the consumer or (ii) processing “sensitive data” of children under the age of eighteen (18) without authorization under the Children’s Online Privacy Protection Act. its territories, or Canada.

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Bill of Health

SEPTEMBER 14, 2022

These companies, who have faced repeated allegations of price gouging , require incarcerated people to buy electronic tablets in order to read books or even to access their own mail. These proprietary technologies and private subcontractors merely automate and privatize censorship of both books and mail.

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Hall Render

MARCH 28, 2023

The authority to make those blanket waivers was granted under Sections 1135 and 1812(f) of the Social Security Act and allowed the Department of Health and Human Services (“HHS”) to implement certain regulatory waivers during the PHE. Three-Day Prior Hospitalization/Qualifying Hospital Stay. Benefit Period Blanket Waiver.

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SQA

MAY 24, 2023

2022 Recap & 2023 Outlook: China Pharmaceutical Regulatory Updates, 28 February 2023 In 2022, China issued and implemented a series of drug regulations, including new rules for marketing authorization holders to manage drug quality and guidelines for pharmacovigilance inspections. In addition, a new expression is defined: ALCOA+.

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Hall Render

AUGUST 12, 2022

The covered entity is assumed capable of producing certain electronic formats like a PDF copy but must make other readily producible forms or formats available upon request. If maintained electronically, the PHI must generally be provided electronically, if requested. This may include production through an API or patient portal.

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HIPAA Compliance Licensing Regulatory Compliance 74

Hall Render

DECEMBER 30, 2022

Once a Part 2 program discloses a record for TPO purposes to a Part 2 program, covered entity or business associate with prior written consent, a revocation would only be effective to prevent additional disclosures to those entities. Follow the instructions at [link] for submitting electronic comments. Your primary Hall Render contact.

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HIPAA Health Services Administration Compliance Public Health 75

Hall Render

JUNE 15, 2022

Hall Render blog posts and articles are intended for informational purposes only. 2] Specifically, the FTC issued orders under Section 6(b) of the FTC Act, which authorizes the Commission to conduct studies without a specific law enforcement purpose. [3] Your primary Hall Render contact.

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SQA

SEPTEMBER 2, 2022

The new contents involve marketing authorization holder system, patent protection, and pharmacovigilance, whose regulations just came out in the past few years. The clinical trials aim for China’s marketing authorization of the investigational drugs. Adding correctants to comparator drugs for blinded experiments.

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Health Law Advisor

MAY 25, 2023

Although limited in application to “consumer health data,” the MHMD Act affects a wide array of companies that have had little or no prior involvement with the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (collectively “HIPAA”). Read more about our expansive capabilities and offerings here.

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SQA

OCTOBER 18, 2023

The regulation includes requirements for the following: Competent Authorities GLP Certification Applicants GLP Application Dossier GLP Certification Procedures The GLP certificate is valid for five years. Nevertheless, the authorities can reserve the right to carry out GMP inspections in certain cases despite the agreement.

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Healthcare Law Blog

OCTOBER 25, 2023

iii] The Act also authorizes the CT DCP to impose penalties for instances of non-compliance or violations of the Act. vi] As with the list of pharmaceutical representatives provided by registered pharmaceutical marketing firms, the CT DCP will compile and post a report of all disclosures made pursuant to this annual requirement.

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Licensing Compliance FDA Public Health 52

Healthcare Law Blog

JANUARY 6, 2023

Prior to the PHE, a “practitioner” only included a physician assistant, nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse-midwife, clinical social worker, clinical psychologist, and registered dietitian or nutrition professional. [3]. RHC and FQHC Telehealth Services.

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SQA

OCTOBER 18, 2022

List Health Advance as an “Official Canadian Distributor” Include the text “Health Canada Approved” (Claims of endorsement by government authorities, such as Health Canada, are not permitted.). .” instead of BTNX Inc. Counterfeit health products are imitations of authentic products.

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

Health Populi

JANUARY 6, 2022

Autos, TVs, and telecomms are the usual fare of the big stage speeches at the annual big show of consumer electronics. For more on that collaboration, please see my blog post which describes the program which launched in June 2020].

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SQA

FEBRUARY 26, 2024

During the operation, food supplements, cannabidiol in various presentations, testosterone, perfumes, and sibutramine tablets were identified, including about 6,000 units of electronic cigarettes and 35,500 packs of cigarettes. The products found, subject to retention and seizure, were retained by the Federal Revenue Service.

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FDA Compliance COVID-19 Public Health 52

Drug & Device Law

JULY 31, 2023

We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. 19, comment f. Dastar Corp. Twentieth Century Fox Film Corp. ,

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