Amaru J. Sanchez, JD, MPH

American Privacy Rights Act (APRA) Update  Lawmakers released a revised version of the American Privacy Rights Act (APRA), moving it out of subcommittee unanimously to the full Energy and Commerce Committee on May 23.  APRA aims to establish federal data privacy laws but includes preemption provisions that override stronger state protections like those in California.  Average Internet use is nearly seven hours daily, generating significant amounts of data and underscoring the need for robust privacy legislation.  APRA revisions expanded from 53 to 174 pages, yet concerns remain about preemption, sensitive information, profiling, and government service provider protections. Key Changes: Ø Targeted Advertising : The bill allows broader data collection for targeted ads, raising concerns about potential loopholes. Ø Child Protections : Elements of COPPA 2.0 were included, but protections for minors are seen as insufficient. Ø Data Deletion : Adds a mechanism for deleting data not directly collected by brokers, akin to California's “Delete Act.” § Despite improvements, APRA’s preemption clause could limit states' abilities to enforce stronger privacy laws, reducing the authority of state agencies and attorneys general. § The journey for APRA is ongoing, with further legislative hurdles before potential presidential approval. Stay informed on developments. Source: https://lnkd.in/gC7TBaXR

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In their new Forefront article, Zachary Baron, Andrew Twinamatsiko, and Sheela Ranganathan from O'Neill Institute for National and Global Health Law discuss how the recent election results will usher in sweeping changes for major federal health care policies, programs, and the courts. "And with Republicans flipping the U.S. Senate by a comfortable margin, President-elect Trump will also be able to easily confirm federal judges in the conservative mold of those he appointed during his first term in office. Republicans will maintain a slim majority in the U.S House of Representatives, providing them with unified control of the federal government, but the limitations of reconciliation rules as well as political constraints could limit the scope of health care legislative measures. Appointments and other unplanned vacancies (multiple House Republicans have already been linked to cabinet-level or senior Administration roles) could further complicate the legislative agenda." Read the full article here: https://bit.ly/4i2bgbB

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A Prediction on the Louisiana #ContractPharmacy Law? Last Thursday, a US District Court heard oral argument on the constitutional challenges brought by PhRMA AstraZeneca, and AbbVie to the LA CP law. Although it’s always hard to predict an outcome from an argument, I’m going to tempt fate. The judge is still finding his legs in what he described as a “complicated case”. Even so, he showed little interest in all but one claim—a subset of the “#preemption” issues. But I think he’s leaning in the state’s direction, even on those claims. Limited Questions: The judge showed little interest in most of the claims. Pretty much zippo questions on the argument that the state law was an unconstitutional taking of #drug makers’ property without just compensation (an argument I like) or that the law is too vaguely drafted (not a great argument), for instance. Preemption: Where the court did show some interest was the issue of whether the state law is preempted because it conflicts with the #340B statute. Even here, though, the court seemed disinterested in some versions of the preemption challenge; the court did not really engage on the (pretty sound) argument that the state law conflicts with the federal patent laws, impeding the value of #patents by imposing #pricecontrols. And though the court showed a little more interest re: the argument that the 340B statute laid out a comprehensive balance of benefits and obligations that the state is disturbing, he didn’t seem likely to bite there, either. He wondered out loud a few times why a CP law would conflict with the federal law so long as the “link to a [legitimate] #coveredentity” was present. The court showed the most interest in the question of whether the 340B statute’s enforcement mechanisms would be undermined by the state law. The court seemed to telegraph that its ultimate view of the “enforcement preemption” issue would boil down to the question of whether the state statute was a “pricing” or a “delivery” provision. P vs. D: If the state law is a “pricing” statute, the court suggested, it would likely be preempted. The 340B statute and the Supremes’ decision in the Santa Clara case really do seem to frame federal mechanisms, including #HRSA’s Administrative Dispute Resolution, as the exclusive means for addressing “pricing” or “overcharge” issues. But, if the state law is only about “delivery”, the court’s working hypothesis seemed to be that the 3rd and DC Circuit opinions hold that the 340B statute is “silent” on those issues. If so, the court appeared to reason, “silence” can’t be the basis for a state-federal conflict. Where Is the Court Headed?: Good question! Please see the comments below for my prediction. #lifescienses #healthcare #pharmaceuticals #drugpricing

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Yesterday, The Supreme Court of the United States ruled 5-4 in favor of the San Carlos Apache Tribe and Northern Arapaho Tribe. The issue at the center of the case, titled Becerra v. San Carlos Apache Tribe, is what costs the Indian Health Service must pay. Leaders of the National Indian Health Board, Native American Rights Fund, and the National Congress of American Indians have applauded the Supreme Court's decision supporting Tribal sovereignty and self-determination. Follow Leadership Connect to stay up to date with all things intergovernmental affairs. Does this Supreme Court decision affect you or your community? Let us know in the comments below. #leadershipconnect #tribalsovereignty #selfdetermination #intergovernmentalaffairs

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The United States Court of Appeals 5th Circuit just announced it will not adopt a proposed rule specifically requiring disclosure and other requirements for attorneys who use AI as part of their practice. Upon reflection, and based upon a lot of negative feedback on the proposed rule, they recognized that existing rules already cover the same situations. Specifically, attorneys are enforceably required to stand behind the truthfulness and accuracy of court filings. However, the court admonished litigants and lawyers alike that “I used AI” will not be an acceptable excuse for violating existing rules! Here is the formal notice from the court: https://lnkd.in/gJWyEyxg For color, here also are some recent news articles on this announcement: * Reuters: https://lnkd.in/gJmjWSqv * Bloomberg Law: https://lnkd.in/gaVqCkHi And, since I have it at hand, for your convenience, here is the full statement by the court: “The court, having considered the proposed rule, the accompanying comments, and the use of artificial intelligence in the legal practice, has decided not to adopt a special rule regarding the use of artificial intelligence in drafting briefs at this time. Parties and counsel are reminded of their duties regarding their filings before the court under Federal Rule of Appellate Procedure 6(b)(1)(B). Parties and counsel are responsible for ensuring that their filings with the court, including briefs, shall be carefully checked for truthfulness and accuracy as the rules already require. “I used AI” will not be an excuse for an otherwise sanctionable offense.” Personally, I think this court got it right. To the extent existing rules cover situations arising from use (or misuse) or AI, it is a good idea to apply those rules first before seeking to make more rules. In the event of demonstrable failures of existing rules, then perhaps it will be more practical to craft new rules to address the gaps that have been revealed. But it is, apparently, a very good idea to sound the alarm far and wide, loud and clear: sometimes generative AI provides incorrect or otherwise unsuitable information and it remains the duty of the attorney (among others) to carefully review and stand behind any work they pass forward. That concludes my public service announcement for today :-)

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for your use

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In my blog post for the Villanova University Charles Widger School of Law Intellectual Property Law Society Blog, I write about the recent FTC endorsement of the FDA's updated Biosimilar Interchangeability Guidelines. Thank you IP Law Society for letting me write this #newblogpost ! https://lnkd.in/eQEMsP72

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🚨 Update on new state laws allowing IMGs to practice without U.S. residency or fellowship! The Advisory Commission on Additional Licensing Models has released draft preliminary recommendations for public comment. The recommendations, once finalized, are intended for state medical boards, state legislators, policymakers and interested stakeholders to help inform those jurisdictions interested in developing or modifying additional licensing pathways for physicians who have completed training internationally. Read the full draft here https://lnkd.in/eYDXArrE And read more details about the new state laws here https://lnkd.in/esPvyYV4

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With over 40 states having introduced legislation on #ArtificialIntelligence and state bars issuing #LegalEthics opinions, the American Bar Association joined in yesterday with its first formal opinion on the use of #GenerativeArtificialIntelligence. ABA Formal Opinion 512 advises counsel on the proper use of #GenAI, and it provides references to various ABA Model Rules of Professional Conduct, including Rule 1.1 on Competence and Rule 1.5 on Fees, providing that lawyers may bill clients for the time for verifying GenAI accuracy--but you can't bill the client for learning how to use it. You can find the ABA's summary and a link to Formal Opinion 512 here: https://lnkd.in/e5PUcKt4

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#HRSA #ADR Rule Effective TODAY: Brace Yourself for a Flood of #CoveredEntity Complaints I really enjoyed speaking today on the American Conference Institute’s #FSS and #340B webinar with Ross Margulies from Foley & Lardner LLP. Ross did a terrific job covering both the basics and intermediate lessons on 340B participation, developments, and its pitfalls—great stuff. But one of the most important points that he made is that HRSA’s ADR final rule became effective today! I’m expecting a huge bolus of complaints to be headed HRSA’s way by disgruntled covered entities and trade associations representing them. A dispute-ridden program is about to get a whole lot more disputier. Buckle up, people. #lifesciences #Protect340B #pharmacy #contractpharmacy #compliance #healthcarecompliance #drugpricing #drugs #PhRMA #BIO

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HHS' new final #HIPAA Privacy Rule to Support Reproductive Health Care Privacy is out. The National Health Law Program is analyzing the rule and will publish a summary soon. In the meantime, here are some highlights: 1. HHS OCR issues this final rule in recognition of the changing post-Dobbs legal landscape. This landscape increases the likelihood that an individual’s protected health information (PHI) may be disclosed in ways that harm the interests that HIPAA seeks to protect, including our trust in our health care providers and the health care system. It recognizes that these disclosures have a disproportionate impact on people of reproductive age, especially individuals from communities that have been historically underserved, marginalized, or subject to discrimination or systemic disadvantage based on race, disability, social or economic status, geographic location, or environment. Underserved communities are also more likely to be the subjects of investigations and other activities to impose liability for seeking or obtaining reproductive health care, even where such health care is lawful under the circumstances in which it is provided. They are also less likely to have adequate access to legal counsel to defend themselves against criminalization. 2. The final rule prohibits the use or disclosure of protected health information (PHI) when it is sought to investigate or impose liability on individuals, providers, or others who seek, obtain, provide, or facilitate reproductive health care permitted by law, or to identify people for such activities. 3. It requires a regulated health care provider, health plan, clearinghouse, or their business associates to obtain a signed attestation that certain requests for PHI potentially related to reproductive health care are not for these prohibited purposes. 4. It requires regulated health care providers, health plans, and clearinghouses to modify their Notice of Privacy Practices to support reproductive health care privacy. Final Rule:

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Today, in Class! Week 7 in the Pharmaceutical Fraud and Abuse Law seminar at the University of Maryland Francis King Carey School of Law will take us back to 2004 and the Schering Plough case. Critics point to it as a “sham exclusion”. Schering-Plough Sales Corp (Sales), a rather insubstantial marketing sub, pled guilty to #criminal #kickback charges and paid a criminal fine of $52.5M, while the big dog, #Schering-Plough Corporation (Corp), avoided any criminal plea and instead paid $292M to resolve related #FalseClaimsAct allegations. The case focused on SP’s #Claritin, its blockbuster #allergy #medication. Corp entered into a Corporate Integrity Agreement, avoiding an exclusion, but Sales was excluded. Criminal Charges: Sales pled to paying Cigna Healthcare “a kickback of $1.8M” to keep Claritin “on its formulary”. Claritin was, #DOJ said, “more expensive…than its biggest competitor, #Allegra”. When #Cigna demanded a price reduction for Claritin, Sales demurred, lest the reduced price set a new, lower Best Price and ratchet up Schering’s #Medicaid rebates. Sales made “up the difference between the price of Claritin and Allegra by offering” Cigna “a $10 million package of added value”, including what the government said was a bogus “data fee”. Civil Claims: Corp agreed to resolve allegations it manipulated Best Price for Claritin by paying kickbacks to both Cigna and PacifiCare. In allegations that clearly overlapped the criminal plea, both Cigna and Pacificare “threatened to remove Claritin from their respective drug formularies in favor of the less expensive, Allegra”, and, in order to “match Allegra's price and keep Claritin on those formularies”, without affecting Best Price, Corp “funded significant price concessions” to both payers. Cigna, in addition to the “data fee” which was “the subject of the criminal charge”, also was provided “deeply discounted Claritin” reditabs, “health management services at far below fair market value”, and an “interest free loan in the form of prepaid rebates”. PacifiCare was provided a “risk share arrangement in which Schering covered a portion of the managed care customer’s respiratory drug costs, deep discounts on other Schering products”, payments towards an “Internet development”, and an “interest free loan in the form of prepaid rebates”. A Sham: As the overlap in the criminal and civil allegations shows, Schering-Plough Corp was every bit as responsible, in the government’s eyes, for the conduct that formed the basis for the criminal plea. But it was too big to exclude. So Sales, an insignificant sub, was inserted as the sacrificial lamb for exclusion. Thus, critics of the HHS Office of Inspector General’s deployment of its exclusion powers refer to this case as a “sham exclusion”. It’s Good to Be a Whistleblower: The 3 relators, former employees of another Schering sub, took in a cool $31.6 million. Not. Too. Shabby. #lifesciences #drugpricing #oig #hhs #cms #managedcare

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How should universities, medical centers and other research institutions think about the federal government’s proposed changes to key regulations governing the review of allegations of research misconduct? In JAMA, our health care and higher education attorneys Minal Caron and Mark Barnes and Harvard Medical School professor Barbara Bierer examine the proposed changes and potential implications for institutions that conduct federally funded research, and offer thoughtful takeaways for the research community. #HealthCare #HigherEd #ResearchMisconduct #ResearchIntegrity

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A new era in regulating the use of #AI in #healthcare has begun with the Biden Administration’s final revised rule under Section 1557. Within 300 days of the effective date of the rule (about one year from now), health systems will need to satisfy an “ongoing duty to make reasonable efforts to identify uses of patient care decision tools” that use input variables that measure race, color, national origin, sex, age, or disability. Health systems then “must make reasonable efforts to mitigate the risk of discrimination” resulting from the use of the tools that are identified pursuant to this ongoing duty. But HHS OCR is not done. In the rule, HHS OCR expressly asks for additional comments on whether it should engage in additional rulemaking to address non-clinical decision-making tools (i.e., those that do not directly impact patient care or clinical decision making) and whether those tools should also be covered under this new regime. HHS OCR specifically raises the question of automated tools for billing, scheduling, and resource allocation. The preamble to the final rule also provides critical detail on HHS OCR’s view of what constitutes “reasonable efforts” to identify risks and to mitigate those risks. To begin, HHS OCR expressly states that health systems “must exercise due diligence when acquiring and using such tools to ensure compliance” with the regulation. According to HHS OCR, a health system may satisfy this “due diligence” requirement by consulting the disclosures required by certified health IT developers, by reviewing resources published by HHS, by monitoring published academic literature, by reviewing reports through media outlets, and by participating in professional and hospital associations.   When evaluating whether a health system has adequately taken “reasonable efforts” to identify potential risks, HHS OCR states that it will consider the system’s size and resources; whether the system used the tool in a manner and under the conditions intended by the developer and approved by regulators; whether the system reviewed the product information from the developer regarding the potential for discrimination; and whether the system has a methodology or process in place for evaluating the tools it adopts (e.g., the “due diligence” concept just discussed). For mitigation, HHS OCR notes that health systems are encouraged to establish written policies and procedures for the use of these tools in decision-making, including governance measures; to monitor potential impacts and develop ways to address complaints; and to train staff on the purpose of the use of the tools in clinical decision-making. This regulation is essentially creating a new era of healthcare AI diligence by the end users of healthcare AI, and it will require a high level of ongoing collaboration between a health system’s legal counsel, chief AI officer, chief medical officer, and Section 1557 coordinator. #healthlaw #healthequity 

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Attention: AI-washers. If your co. is making AI-related claims, then this settlement agreement between the Texas AG and Pieces Technologies Inc. should be of interest. The company was alleged to have made false and misleading statements about the accuracy of its Gen AI hallucination rates in violation of the Texas Consumer Protection Act. The settlement terms require Pieces “to clearly and conspicuously disclose (1) the meaning or definition of [any] metric, benchmark, or similar measurement; and (2) the method, procedure, or any other process used by [Pieces], or on [Pieces’] behalf, to calculate the metric, benchmark, or similar measurement used in [the company's] marketing or advertising of its products and services [or retain an independent third-party auditor].” The takeaways, arguably, are: (i) Carefully review any claims about LLM/AI’s accuracy or hallucination rates. (ii) Consider clear disclaimers about the risks, if any, involved in using the company's AI tool. Link is the Texas PR but at the end of the PR is a link to the settlement agreement. https://lnkd.in/gJm554Ck

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Kilpatrick attorneys Yifan Mao and Stuart Eric Pollack, Ph.D. recently attended the 20th annual KTIPS (Kilpatrick Townsend Intellectual Property Seminar) to discuss the “The Federal Circuit’s New § 112 Attack on Biotechnology: Diagnosis and Prescription.” The recent rulings from the Federal Circuit have emphasized the importance of the written description and enablement defenses in patent litigation and prosecution, particularly in the field of biotechnology. This new case law now requires that inventors provide a detailed process for identifying new antibodies, peptides, proteins, and nucleic acids that may be discovered in the future and providing structural information for these bioproducts. This session described the new law, discussed the implications and suggested effective approaches to counter these defenses during patent prosecution. Read their 7 Key Takeaways here: https://lnkd.in/d7YP_uKx

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In my personal capacity as a Medicaid policy lawyer, former staffer at the U.S. Centers for Medicare & Medicaid Services (CMS), and former Medicaid enrollee, I’m beside myself over President-Elect Trump’s nomination of Dr. Oz to head CMS. I cannot stress enough how scary it is that we’ll have a misinformation hack at the head of the agency that runs and/or regulates health insurance in the U.S., especially Medicaid. Medicaid currently provides access to affordable, comprehensive, high-quality, and cost-effective health insurance coverage, including sexual and reproductive health care coverage, for more than 72 million people across the United States. This includes roughly one in five women and 1.2 million LGBTQI+ adults, many of whom are people of color or people with disabilities. Medicaid, including Medicaid expansion, helps women and LGBTQI+ people with low incomes live healthier and more economically secure lives by increasing the diagnosis and early treatment of chronic conditions, enhancing educational achievement and higher rates of future employment and earnings for covered children, as well as reducing intergenerational health inequities. Medicaid expansion has also been associated with preventing tens of thousands of premature deaths each year. Medicaid provides vital coverage for 41% of U.S. births, including 64% of births among Black women, and is the leading source of family planning coverage in the U.S. It is also critical for people with disabilities, providing crucial services such as long-term services and supports, and behavioral health services. Medicaid is the leading source of coverage for people with HIV, and Medicaid expansion has been particularly critical in making progress toward ending the HIV epidemic: increasing HIV diagnoses, promoting access to critical treatments and preventive services, and improving outcomes.  Dr. Oz stands to run this vital program into the ground. Please tell your Senators to vote NO on his appointment. https://lnkd.in/eVy_Yd8P

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