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Australia to ban minors from accessing social media

November 28, 2024

One of the biggest concerns for parents in the modern world is their children's use of social media. Depending on how they are used, social media can become a huge headache for parents and their children tend to be the most vulnerable part in this unfiltered environment, where a world of discoveries is just a click away.

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Artificial intelligence and its regulation in Brazil

November 22, 2023

On March 29, 2023, “The New York Times” published an article regarding an open letter signed by more than a thousand leaders in the technology sector, including Elon Musk, president of Tesla, Space X, and X (formerly Twitter). The letter requested a stop in the development of artificial intelligence above GPT-4, developed by OpenAI, considering the potential risk of threatening the very existence of society as we know it and even humanity.

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ANVISA Approves the Regulation of Biosimilars

June 18, 2024

The Brazilian FDA, ANVISA, approved Rule RDC #875 of May 28, 2024, which provided, in an ancillary manner, for the registration of biosimilars through the comparability development route, aiming to guarantee the quality, safety, and efficacy of these products.

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Antitrust and anti-corruption authorities are already monitoring the 2026 World Cup

October 3, 2023

Considering the financial scandals fueled by acts of corruption involving the most recent World Cup, which led to the arrest of leaders from several countries, North American antitrust and anti-corruption authorities turned their attention to the 2026 World Cup, which will take place in three countries: United States, Canada, and Mexico. Among the arrests made, one that stood out was that of José Maria Marín, former president of the Brazilian Football Confederation (CBF) between 2012 and 2015 who was also governor of the State of São Paulo between 1982 and 1983, after the death of governor Franco Montoro.

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ANS' role is now Exemplary once again by Law. Read here what this means

September 26, 2022

Last Wednesday (September 21), the press trumpeted the enactment of a new law, especially the G1 news outlet, informing that healthcare providers are obliged to cover treatments outside the list of the Brazilian Supplementary Health Agency (ANS).

This is another chapter in the fierce dispute between providers and patients, mediated by the authorities. Healthcare providers claim an imbalance in their financial health, while patients denounce lack of coverage and excessive costs in their assistance.

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ANS' List of Procedures is exhaustive, according to the Brazilian Superior Court of Justice. What does this mean for us?

June 13, 2022

On June 8, 2022, Brazil witnessed the unfolding of another chapter involving healthcare plans, patients and the Brazilian Agency of Supplementary Health (ANS), this time at the headquarters of the Brazilian Superior Court of Justice (STJ), in Brasilia.

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ANPD REGULATES THE APPLICATION OF ADMINISTRATIVE SANCTIONS

March 7, 2023

Administrative Sanctions Regulation on Dosimetry and Application of Administrative Sanctions, which establishes the dosimetry guidelines for sentences, especially calculating the base value for fines the agency may apply. It is an initiative of the rapporteur and director of the ANPD – Arthur Sabbat, in which he was unanimously followed by the rest of the board. Although the criteria set out below establish clear guidelines, the ANPD may depart from its methodology or review the penalty, if impaired proportionality is found between the severity of the violation and the intensity of the sanction.

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ANPD launches new security incident form

February 1, 2023

In the second half of December 2022, the National Data Protection Authority (ANPD) published an amendment to the Security Incident Reporting form, to be used by all those who need to report security incidents starting January 1, 2023.

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ANPD is transformed into an Autonomous Agency

June 20, 2022

On this 13th of June, the Brazilian government issued the Executive Order #1,124, which was also published in the Federal Gazette on June 14, 2022. Containing 10 articles, it enters into force on the date of its publication.

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ANPD Approves Regulation on Security Incident Reporting

May 8, 2024

The Brazilian Data Protection Authority (ANPD), a public entity created by the General Data Protection Act (LGPD), responsible for regulating, supervising, guiding, educating, and acting on security incidents involving personal data, as well as for cooperating with other similar international entities, published CD/ANPD’s Rule #15, dated April 24, 2024, in the Federal Register on April 26, 2024. Taking advantage of the last public consultation on the topic, the Rule approved the Regulation on Security Incident Reporting.

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ABOUT US

Licks Attorneys Compliance’s Blog provides regular and insightful updates about Ethic and Compliance. The posts are authored by Alexandre Dalmasso, our partner. Licks Attorneys is a top tier Brazilian law firm, specialized in Intellectual Property and recognized for its success handling large and strategic projects in the country.

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Licks Attorneys' COMPLIANCE Blog

Brazilian Federal Pharmacy Council regulates the practice of Telepharmacy

On July 20, 2022, the Brazilian Federal Pharmacy Council (CFF) published Rule #727/2022, meeting a pressing need in the sector, with the rampant advancement of technology, by regulating the practice of Telepharmacy in Brazil.

Brazilian Federal Pharmacy Council regulates the practice of TelepharmacyRead Full Article

Italy issues new Transparency Law in Healthcare Sector

The interaction between the pharmaceutical and the medical devices industries and doctors has always been reason of concern for the authorities and the population, due to the potential conflict of interests that can be established with the concession of advantages given by the industry, in form of scientific support, gifts, meals, etc… which could interfere especially in the doctor's judgment in choosing the best treatment for their patient.

Italy issues new Transparency Law in Healthcare SectorRead Full Article

The Ultimate Guide to Data Leakage

The Brazilian Computer Emergency Response Team (CERT.br) from the Brazilian Network Information Center (NIC.br) – which is the executive branch of the Brazilian Internet Steering Committee (CGI.br) – has been in charge of dealing with security incidents involving networks connected to the Internet in Brazil since 1997. With the collaboration of Brazilian Data Protection Authority (ANPD), they have published the Guide to Data Leakage with the purpose of guiding people on the potential risks of data processing in digital environments.

The Ultimate Guide to Data LeakageRead Full Article

Regulation of the Overindebtedness Act is Approved

On July 1, 2021, Statute #14,181, also known as the Overindebtedness Act, was approved. It amended the Brazilian Consumer Protection Code and the Brazilian Elderly Bill of Rights with the purpose of protecting individuals who, in good faith, contracted debts above their ability to pay and without compromising their social minimum, with the exception of consumers of luxury items, which are not protected.

Regulation of the Overindebtedness Act is ApprovedRead Full Article

When Integrity Counts

A lot is said about integrity, but examples of its practice are not always seen on a daily basis. Conversely, there are controversial situations in which actions that could be considered ethical are questionable due to their results.

When Integrity CountsRead Full Article

Items required for the Compliance Program are changed by New Regulation

The Brazilian government edited Decree #11,129 on this Monday, July 11, 2022, updating the regulation of the Brazilian Anti-Corruption Act (Statute #12,846 of August 1, 2013) and bringing some changes to the content of Decree #8,420 of March 18, 2015, which was responsible for such regulation.

Items required for the Compliance Program are changed by New RegulationRead Full Article

Brazilian Comptroller General Launches a Handbook for Handling Conflicts of Interest

The Office of the Comptroller General (CGU) announced on June 4, 2022, the release of its newest document: the Handbook for Handling Conflicts of Interest.

Brazilian Comptroller General Launches a Handbook for Handling Conflicts of InterestRead Full Article

Sexual harassment complaints at CEF and the integrity program

On June 29, 2022, several media outlets, including the Isto É Dinheiro magazine, published revelations that, despite the political capitalization by the government's opponents, brought to light a worrying threat to the effectiveness of the integrity programs implemented in the various government entities.

Sexual harassment complaints at CEF and the integrity programRead Full Article

Information Wall – A Growing Need

On May 9, 2022, the website “Policy & Medicine” published an interesting article signed by Thomas Sullivan titled “McKinsey – Serving as a Double Agent?”. It describes that the Oversight and Reform Committee on the US House of Representatives issued a report concluding that 22 consultants from the renowned McKinsey consulting firm were assigned to work simultaneously with the US government and with opioid manufacturers.

Information Wall – A Growing NeedRead Full Article

ANPD is transformed into an Autonomous Agency

On this 13th of June, the Brazilian government issued the Executive Order #1,124, which was also published in the Federal Gazette on June 14, 2022. Containing 10 articles, it enters into force on the date of its publication.

ANPD is transformed into an Autonomous AgencyRead Full Article

ANS' List of Procedures is exhaustive, according to the Brazilian Superior Court of Justice. What does this mean for us?

On June 8, 2022, Brazil witnessed the unfolding of another chapter involving healthcare plans, patients and the Brazilian Agency of Supplementary Health (ANS), this time at the headquarters of the Brazilian Superior Court of Justice (STJ), in Brasilia.

ANS' List of Procedures is exhaustive, according to the Brazilian Superior Court of Justice. What does this mean for us?Read Full Article

The DPO is recognized in the Brazilian Classification of Occupations

The first step towards recognizing the profession of Data Protection Officer (DPO) in Brazil, which was introduced by the definition contained in Article 5, VIII of the Brazilian Data Privacy Act (LGPD) – Statute #13,709/2018. This step was taken with its inclusion in the Brazilian Classification of Occupations (CBO), created by Ordinance #397 of October 10, 2002.

The DPO is recognized in the Brazilian Classification of OccupationsRead Full Article

The FDA unifies Premarket Review for Combination Products

In January 2022, the Food and Drug Administration (FDA) published an interesting guide, called Principles of Premarket Pathways for Combination Products, which establishes the unification of premarket review of combination products.

The FDA unifies Premarket Review for Combination ProductsRead Full Article

Advances in Telemedicine Regulation in Brazil

Up until now, telemedicine in Brazil had been regulated by Law 13,989 of April 15, 2020, which provided for the use of telemedicine during the crisis caused by the coronavirus (SARS-COV-2). That is, apparently there was only regulation approved in Congress, after the country faced a national emergency, because of the pandemic that was expanding and causing deaths and sequelae wherever it arrived, forcing social isolation. In fact, social isolation was the driving force for services, such as those resulting from the use of telemedicine.

Advances in Telemedicine Regulation in BrazilRead Full Article