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The Evolution of AI in Healthcare: Current Trends and Legal Considerations

Artificial intelligence (AI) is transforming the healthcare landscape, offering innovative solutions to age-old challenges. From diagnostics to enhanced patient care, AI’s influence is pervasive, and seems destined to reshape how healthcare is delivered and managed. However, the rapid integration of AI technologies brings with it a complex web of legal and regulatory considerations that physicians must navigate.

It appears inevitable AI will ultimately render current modalities, perhaps even today’s “gold standard” clinical strategies, obsolete. Currently accepted treatment methodologies will change, hopefully for the benefit of patients. In lockstep, insurance companies and payors are poised to utilize AI to advance their interests. Indeed, the “cat-and-mouse” battle between physician and overseer will not only remain but will intensify as these technologies intrude further into physician-patient encounters.

Current Trends in AI Applications in Healthcare

As AI continues to evolve, the healthcare sector is witnessing a surge in private equity investments and start-ups entering the AI space. These ventures are driving innovation across a wide range of applications, from tools that listen in on patient encounters to ensure optimal outcomes and suggest clinical plans, to sophisticated systems that gather and analyze massive datasets contained in electronic medical records. By identifying trends and detecting imperceptible signs of disease through the analysis of audio and visual depictions of patients, these AI-driven solutions are poised to revolutionize clinical care. The involvement of private equity and start-ups is accelerating the development and deployment of these technologies, pushing the boundaries of what AI can achieve in healthcare while also raising new questions about the integration of these powerful tools into existing medical practices.

Diagnostics and Predictive Analytics:

AI-powered diagnostic tools are becoming sophisticated, capable of analyzing medical images, genetic data, and electronic health records (EHRs) to identify patterns that may elude human practitioners. Machine learning algorithms, for instance, can detect early signs of cancer, heart disease, and neurological disorders with remarkable accuracy. Predictive analytics, another AI-driven trend, is helping clinicians forecast patient outcomes, enabling more personalized treatment plans.

Telemedicine and Remote Patient Monitoring:

The COVID-19 pandemic accelerated the adoption of telemedicine, and AI is playing a crucial role in enhancing these services. AI-driven chatbots and virtual assistants are set to engage with patients by answering queries and triaging symptoms. Additionally, AI is used in remote and real-time patient monitoring systems to track vital signs and alert healthcare providers to potential health issues before they escalate.

Drug Discovery and Development:

AI is revolutionizing drug discovery by speeding up the identification of potential drug candidates and predicting their success in clinical trials. Pharmaceutical companies are pouring billions of dollars in developing AI-driven tools to model complex biological processes and simulate the effects of drugs on these processes, significantly reducing the time and cost associated with bringing new medications to market.

Administrative Automation:

Beyond direct patient care, AI is streamlining administrative tasks in healthcare settings. From automating billing processes to managing EHRs and scheduling appointments, AI is reducing the burden on healthcare staff, allowing them to focus more on patient care. This trend also helps healthcare organizations reduce operational costs and improve efficiency.

AI in Mental Health:

AI applications in mental health are gaining traction, with tools like sentiment analysis, an application of natural language processing, being used to assess a patient’s mental state. These tools can analyze text or speech to detect signs of depression, anxiety, or other mental health conditions, facilitating earlier interventions.

Legal and Regulatory Considerations

As AI technologies become more deeply embedded in healthcare, they intersect with legal and regulatory frameworks designed to protect patient safety, privacy, and rights.

Data Privacy and Security:

AI systems rely heavily on vast amounts of data, often sourced from patient records. The use of this data must comply with privacy regulations established by the Health Insurance Portability and Accountability Act (HIPAA), which mandates stringent safeguards to protect patient information. Physicians and AI developers must ensure that AI systems are designed with robust security measures to prevent data breaches, unauthorized access, and other cyber threats.

Liability and Accountability:

The use of AI in clinical decision-making raises questions about liability. If an AI system provides incorrect information or misdiagnoses a condition, determining who is responsible—the physician, the AI developer, or the institution—can be complex. As AI systems become more autonomous, the traditional notions of liability may need to evolve, potentially leading to new legal precedents and liability insurance models.

These notions beg the questions:

Will physicians trust the “judgment” of an AI platform making a diagnosis or interpreting a test result?
Will the utilization of AI platforms cause physicians to become too heavily reliant on these technologies, forgoing their own professional human judgment?

Surely, plaintiff malpractice attorneys will find a way to fault the physician whatever they decide.

Insurance Companies and Payors:

Another emerging concern is the likelihood that insurance companies and payors, including Medicare/Medicaid, will develop and mandate the use of their proprietary AI systems to oversee patient care, ensuring it aligns with their rules on proper and efficient care. These AI systems, designed primarily to optimize cost-effectiveness from the insurer’s perspective, could potentially undermine the physician’s autonomy and the quality of patient care. By prioritizing compliance with insurer guidelines over individualized patient needs, these AI tools could lead to suboptimal outcomes for patients. Moreover, insurance companies may make the use of their AI systems a prerequisite for physicians to maintain or obtain enrollment on their provider panels, further limiting physicians’ ability to exercise independent clinical judgment and potentially restricting patient access to care that is truly personalized and appropriate.

Licensure and Misconduct Concerns in New York State:

Physicians utilizing AI in their practice must be particularly mindful of licensure and misconduct issues, especially under the jurisdiction of the Office of Professional Medical Conduct (OPMC) in New York. The OPMC is responsible for monitoring and disciplining physicians, ensuring that they adhere to medical standards. As AI becomes more integrated into clinical practice, physicians could face OPMC scrutiny if AI-related errors lead to patient harm, or if there is a perceived over-reliance on AI at the expense of sound clinical judgment. The potential for AI to contribute to diagnostic or treatment decisions underscores the need for physicians to maintain ultimate responsibility and ensure that AI is used to support, rather than replace, their professional expertise.

Conclusion

AI has the potential to revolutionize healthcare, but its integration must be approached with careful consideration of legal and ethical implications. By navigating these challenges thoughtfully, the healthcare industry can ensure that AI contributes to better patient outcomes, improved efficiency, and equitable access to care. The future of AI in healthcare looks promising, with ongoing advancements in technology and regulatory frameworks adapting to these changes. Healthcare professionals, policymakers, and AI developers must continue to engage in dialogue to shape this future responsibly.

New York To Require Licensure of Pharmacy Benefit Managers

In an effort to counteract rising prescription drug costs and health insurance premiums, New York Governor Hochul signed S3762/A1396 (the Act) on December 31, 2021. This legislation specifies the registration, licensure, and reporting requirements of pharmacy benefit managers (PBMs) operating in New York. The Superintendent of the Department of Financial Services (Superintendent) will oversee the implementation of this legislation and the ongoing registration and licensure of PBMs in New York. Notably, this legislation establishes a duty of accountability and transparency that PBMs owe in the performance of pharmacy benefit management services.

Though the Governor only recently signed the Act, on January 13, 2022, an additional piece of legislation, S7837/A8388, was introduced in the New York Legislature. If passed, this legislation would amend and repeal certain provisions proposed in the Act. As of the date of this blog post, both the Senate and Assembly have passed S7837/A8388, and it has been delivered to the Governor for signature. Anticipating that Governor Hochul will sign S7837/A8388 into law, we have provided an overview of the Act, taking into account the impact that S7837/A8388 will have, and the changes that both make to the New York State Insurance, Public Health, and Finance Laws.

New York State Insurance Law: Article 29 – Pharmacy Benefit Managers

The Act adds Article 29 to the Insurance Law. The Section includes, among other provisions, definitions applicable to PBMs, as well as licensure, registration, and reporting requirements, as detailed below.

Definitions

Section 2901 incorporates the definitions of “pharmacy benefit manager” and “pharmacy benefit management services” of Section 280-a of the Public Health Law. “Pharmacy benefit management services” is defined as “the management or administration of prescription drug benefits for a health plan.” This definition applies regardless of whether the PBM conducts the administration or management directly or indirectly and regardless of whether the PBM and health plan are associated or related. “Pharmacy benefit management services” also includes the procurement of prescription drugs to be dispensed to patients, or the administration or management of prescription drug benefits, including but not limited to:

Mail service pharmacy;
Claims processing, retail network management, or payment of claims to pharmacies for dispensing prescription drugs;
Clinical or other formulary or preferred drug list development or management;
Negotiation or administration of rebates, discounts, payment differentials, or other incentives, for the inclusion of particular prescription drugs in a particular category or to promote the purchase of particular prescription drugs;
Patient compliance, therapeutic intervention, or generic substitution programs;
Disease management;
Drug utilization review or prior authorization;
Adjudication of appeals or grievances related to prescription drug coverage;
Contracting with network pharmacies; and
Controlling the cost of covered prescription drugs.

A “pharmacy benefit manager” is defined as any entity that performs the above listed management services for a health plan. Finally, the term “health plan” is amended to encompass entities that a PBM either provides management services for and is a health benefit plan or reimburses, in whole or in part, at least prescription drugs, for a “substantial number of beneficiaries” that work in New York. The Superintendent has the discretion to interpret the phrase “substantial number of beneficiaries.”

Registration Requirements

PBMs currently providing pharmacy benefit management services must register and submit an annual registration fee of $4,000 to the Department of Financial Services (DFS) on or before June 1, 2022 if the PBM intends to continue providing management services after that date. After June 1, 2022, every PBM seeking to engage in management services must register and submit the annual registration fee to DFS prior to engaging in management services. Regardless of when a PBM registers, every PBM registration will expire on December 31, 2023.

Reporting Requirements

On or before July 1 of each year, each PBM must report and affirm the following to the Superintendent, which includes, but is not limited to:

Any pricing discounts, rebates of any kind, inflationary payments, credits, clawbacks, fees, grants, chargebacks, reimbursement, other financial or other reimbursements, inducements, refunds or other benefits received by the PBM; and
The terms and conditions of any contract or arrangement, including other financial or other reimbursement incentives, inducements, or refunds between the PBM and any other party relating to management services provided to a health plan including, but not limited to, dispending fees paid to pharmacies.

The Superintendent may request additional information from PBMs and their respective officers and directors. Notably, the above documentation and information are confidential and not subject to public disclosure, unless a court order compels it or if the Superintendent determines disclosure is in the public’s best interest.

Licensing Requirements

The Superintendent is also responsible for establishing standards related to PBM licensure. The Superintendent must consult with the Commissioner of Health while developing the standards. The standards must address prerequisites for the issuance of a PBM license and detail how a PBM license must be maintained. The standards will cover, at a minimum, the following topics:

Conflicts of interest between PBMs and health plans or insurers;
Deceptive practices in connection with the performance of management services;
Anti-competitive practices connected to the performance of management services;
Unfair claims practices in connection with the performance of pharmacy benefit managements services;
Pricing models that PBMs use both for their services and for payment of services;
Consumer protection; and
Standards and practices used while creating pharmacy networks and while contracting with network pharmacies and other providers and in contracting with network pharmacies and other providers. This will also cover the promotion of patient access, the use of independent and community pharmacies, and the minimization of excessive concentration and vertical integration of markets.

To obtain a license, PBMs must file an application and pay a licensing fee of $8,000 to the Superintendent for each year that the license will be valid. The license will expire 36 months after its issuance, and a PBM can renew their license for another 36-month period by refiling an application with the Superintendent.

New York State Public Health Law: Amendments to Section 280-a

Duty, Accountability, and Transparency of PBMs

As briefly mentioned above, the Act also amends Public Health Law 280-a. Notably, this legislation imposes imposes new duty, accountability, and transparency requirements on PBMs. Under the new law, PBMs interacting with a covered individual have the same duty to a covered individual as the PBM has to the health plan for which the PBM is performing management services. PBMs are also compelled to act with a duty of good faith and fair dealing towards all parties, including, but not limited to, covered individuals and pharmacies. In addition, PBMs are required to hold all funds received from providing management services in trust. The PBMs can only utilize the funds in accordance with its contract with their respective health plan.

To promote transparency, PBMs shall account to their health plan any pricing discounts, rebates, clawbacks, fees, or other benefits it has received. The health plan must have access to all of the PBMs’ financial information related to the management services the PBM provides it. The PBMs are also required to disclose in writing any conflicts of interest PBMs shall disclose in writing any conflicts of interests, as well as disclose the terms and conditions of any contract related to the PBM’s provision of management services to the health plan, including, but not limited to, the dispensing fees paid to pharmacies.

New York State Finance Law: Addition of Section § 99-oo

If enacted, S7837/A8388 will add Section 99-oo to the Finance Law. This law would create a special fund called the Pharmacy Benefit Manager Regulatory Fund (Fund). The New York State Comptroller (Comptroller) and Commissioner of Tax and Finance will establish the Fund and hold joint custody over it. The Fund will primarily consist of money collected through fees and penalties imposed under the Insurance Law. The Comptroller must keep Fund monies separate from other funds, and the money shall remain in the Fund unless a statute or appropriation directs its release.

Looking Forward: PBM Regulation in New York and Beyond

In a January 2, 2022, press release, Governor Hochul touted the Act as “the most comprehensive [PBM] regulatory framework” in the United States. The Governor has made clear her intent to regulate PBMs, and New York lawmakers appear to just be getting started. PBMs in New York and throughout the United States should anticipate their state’s legislatures introducing and enacting more laws and regulations.

Article By Jean D. Krebs, Cody Keetch, Nick L. Torres with Mintz.

For more about pharmacies, visit the NLR Healthcare section.

Phantom Participants with Real-World Ramifications: Clinical Drug Trial Data Falsification

As if medical-related disinformation was not pernicious enough, unscrupulous actors seek to enrich themselves from falsifying clinical drug trial data. A Florida-based clinical research firm project manager was sentenced to 30 months in prison because of his involvement in a conspiracy to falsify clinical drug trial data. Previously, the primary investigator, clinic owner, and another senior employee at Miami-based Tellus Clinical Research were charged with various counts of mail and wire fraud, money laundering, as well as making false statements to Food and Drug Administration (FDA) inspectors. A researcher or other employee of the medical clinic could have reported this conspiracy to the government and shared in 15-25% of the government’s recovery.

Pharmaceutical companies sponsor clinical research trials to gather data on the safety and efficacy of the drugs they manufacture. Prior to commencing research trials, pharmaceutical companies or “sponsors” must submit to the FDA their “study protocol,” which identifies who can participate, drug dosages and timing, and how the study’s performance will be measured. Sponsors engage contract research organizations (CROs) to perform the clinical trials, and the CRO must ensure compliance with the study protocol and FDA regulations. In this case, a clinical research firm contracted with pharmaceutical manufacturers to conduct trials related to an opioid dependency treatment, an irritable bowel syndrome drug, and diabetic nephropathy or kidney disease medication. The sponsors would reimburse the CRO a set amount per study participant and for some fees and Tellus would pay participants in accordance with the study protocol.

How the research firm gamed the system involved the eligibility requirements for the studies: each of these clinical trials required patients to meet certain requirements for participation. Instead of honestly recruiting patients with the diagnoses needed to participate in the program, the defendants enrolled people without applicable diagnoses and falsely claimed that study participants completed all the requirements in the study protocol, to garner more payments from the clinical trial sponsors. Several of the defendants enrolled friends and family members to bump up the research firm’s participation numbers, and other research firm employees went so far as to misappropriate personal information from third parties without their knowledge or consent. The co-conspirators also falsified clinical notes and medical records of these unwitting participants, claiming to have performed medical exams, drawn blood for testing, and made payments to participants. This elaborate conspiracy served to wrongfully enrich the research firm owner and senior management at the expense of pharmaceutical companies and ultimately patients.

Clinical research fraud is harmful to consumers. As the Assistant Commissioner for the FDA Office of Criminal Investigations (OCI) stated, “Compromised clinical trial data could impact the agency’s decisions about the safety and effectiveness of the drug under review.” Consumers could end up with unsafe medications due to fraudsters’ schemes.

A whistleblower could have reported this fraud to the FDA and ensured only drugs which perform well in clinical trials on real human beings make it to market. The Department of Justice needs whistleblowers to report fraud involving clinical drug trials.

Article By Eva Gunaserkera and Renee Brooker with Tycko & Zavareei LLP.

For more content about the FDA and drug trials, visit the NLR Biotech, Food & Drug section.

Supreme Court Stryker/Halo Decision Makes it Easier for Courts to Award Enhanced Damages In Patent Infringement Cases

The recent Supreme Court decisions in the Stryker and Halo cases just made it easier for courts to award enhanced damages in patent infringement cases, discarding Seagate’s “objective recklessness” test.

**The Seagate Test**

In 2007, the Federal Circuit announced a test for enhanced damages whereby a plaintiff seeking enhanced damages had to show that the infringement of his patent was “willful.” In re Seagate Technology, LLC, 497 F. 3d, 1360, 1371. The Federal Circuit set forth a two-part test to establish such willfulness: First, “a patentee must show by clear and convincing evidence that the infringer acted despite an objectively high likelihood that its actions constituted infringement of a valid patent,” without regard to “[t]he state of mind of the accused infringer.” Id., at 1371. This objectively defined risk is to be“determined by the record developed in the infringement proceedings.” Ibid. “Objective recklessness will not be found” at this first step if the accused infringer, during the infringement proceedings, “raised a ‘substantial question’ as to the validity or noninfringement of the patent.” That bar applied even if the defendant was unaware of the arguable defense when he acted.

Second, after establishing objective recklessness, a patentee had to show by clear and convincing evidence the risk of infringement “was either known or so obvious that it should have been known to the accused infringer.”Seagate, 497 F. 3d, at 1371. Only when both steps were satisfied could the district court proceed to consider whether to exercise its discretion to award enhanced damages. Ibid.

Stryker / Halo Decisions Restore Courts’ Discretion to Award Enhanced Damages

The Supreme Court’s recent decision in the Stryker and Halo cases discarded the Seagate test and restored courts’ discretion to award enhanced damages. The Court held “[t]he Seagate test is not consistent with §284.” The relevant language of § 284 contains “no explicit limit or condition on when enhanced damages are appropriate, and this Court has emphasized that the “word ‘may’ clearly connotes discretion.” So the Court found no explicit requirement for Seagate’s “objective recklessness” test.

The Court also found Seagate unnecessarily required a finding of “objective recklessness” even when wrongdoing was demonstrated by the facts of a case. The Court also disagreed with Seagate’s requirement of a “clear and convincing evidence” standard for showing recklessness, and held that the proper standard for enhanced damages was a “preponderance of the evidence” — the same standard as for patent infringement determinations.

The Court explained that its decision did not contradict § 298, that failure to present advice to the court may not be used to prove willful infringement:

Section 298 provides that “[t]he failure of an infringer to obtain the advice of counsel” or “the failure of the infringer to present such adviceto the court or jury, may not be used to prove that the accused infringer willfully infringed.” 35 U.S.C. § 298. Respondents contend that the reference to willfulness reflects an endorsement of Seagate’s willfulness test. But willfulness has always been a part of patent law, before and after Seagate. Section 298 does not show that Congress ratifiedSeagate’s particular conception of willfulness. Rather, it simply addressed the fallout from the Federal Circuit’s opinion in Underwater Devices Inc. v. Morrison-Knudsen Co., 717 F. 2d 1380 (1983), which had imposed an “affirmative duty” to obtain advice of counsel prior to initiating any possible infringing activity, id., at 1389–1390. See, e.g., H. R. Rep. No. 112–98, pt. 1, p. 53 (2011).

Consequently, nine years after Seagate, the Supreme Court has made it easier for courts to make a determination of enhanced damages. Time will tell if this decision will spur additional patent opinion practice, such as prior to the 2007 Seagate decision.

ARTICLE BY Timothy Bianchi of Schwegman, Lundberg & Woessner, P.A.

New Board of Pharmacy Regulations Significantly Narrow the Sole Proprietor Exemption and Impose New Compounding Standards

New regulations from the Ohio State Board of Pharmacy now require any prescriber who will possess, have custody or control of, or distribute dangerous drugs that are compounded or used for the purpose of compounding to be licensed as a Terminal Distributor of Dangerous Drugs (TDDD). This new requirement is particularly noteworthy for physicians, dentists, and others who have previously operated under the “sole proprietor” exemption from licensure as a TDDD. That exemption has been widely used in Ohio and has traditionally permitted practitioners who 1) operate as sole proprietor, sole shareholder of a corporation or professional association, or sole member of a limited liability company; and 2) are the sole authorized prescribers in the practice to be exempt from the TDDD licensure requirements. These new regulations narrow this exemption by now requiring that all prescribers who “compound” or use “compounded” drugs become licensed as a TDDD, even if those prescribers had previously qualified under the “sole proprietor” exemption.

The scope of what constitutes “compounding” is broad – likely broader than what is commonly believed. Ohio law defines “compounding” as the preparation, mixing, assembling, packaging, and labeling of one or more drugs and also includes the reconstitution of drugs in accordance with the manufacturer’s instructions.¹ Under the new regulations, any “compounding” activity, possession, or administration of a compounded drug requires TDDD licensure, even by a previously exempt “sole proprietor.”

Additionally, these same new regulations impose new standards for compounding sterile products, non-sterile products, and hazardous drugs and more stringent rules governing purchase of compounded drugs from in-state pharmacies, out-of-state pharmacies, and outsourcing facilities.² These regulations were imposed in order to bring Ohio into compliance with the 2013 Drug Quality and Security Act, a federal law passed in response to the deadly outbreak of fungal meningitis in 2012 that was linked to the New England Compounding Center.

Article By Eric J. Plinke, Sarah C. Persinger, PharmD, RPh & Daniel S. Zinsmaster

_{¹ Hazardous Drug Compounding by Prescribers}_{² http://codes.ohio.gov/oac/4729-16}

FTC Proposes Amendments to HSR Rules Targeting Certain Pharmaceutical Licensing Arrangements

The National Law Review recently published an article by Robert G. Kidwell and Farrah Short of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. regarding Pharmaceutical Licensing:

The Federal Trade Commission (FTC) recently announced proposed amendments to the Premerger Notification Rules (HSR Rules) to clarify reporting requirements under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the HSR Act), for transactions involving the transfer of patent rights in the pharmaceutical industry. The proposed rule is largely a codification of the FTC’s current treatment of exclusive licenses, with one significant change regarding the weight given to manufacturing rights retained by the licensor in pharmaceutical transactions.

The HSR Act requires parties engaged in certain transactions (involving the acquisition of voting securities, assets, or controlling non-corporate interests) to file a notification with the FTC and the Antitrust Division of the Department of Justice (DOJ), and to observe the statutorily prescribed waiting period prior to closing. Theacquisition of a patent is treated as an asset acquisition, and thus a potentially reportable transaction under the HSR Act. However, whether the transfer of rightsto a patent is also deemed an asset acquisition commonly involves a complex analysis focused on whether the transferred rights grant the licensee theexclusive right to “make, use and sell.”

Commercially Significant Rights

The proposed amendments would codify the reporting requirement under the HSR Act for any transaction within the pharmaceutical industry that involves the transfer of “all commercially significant rights.” These rights are defined as the exclusive patent rights to use the patent in a particular therapeutic area or in a specific indication within a therapeutic area.

The FTC has defined the pharmaceutical industry for purposes of this amendment by specifying NAICS (North American Industry Classification System) code 3254, which includes medical and botanical manufacturing, pharmaceutical preparation manufacturing, in-vitro diagnostic substance manufacturing, and biological product manufacturing. Importantly, the FTC’s proposed amendments are limited to the pharmaceutical industry and do not change the current HSR Act reporting requirements related to exclusive licenses in other industries.

Retained Manufacturing Rights

Under current FTC practice, transactions where the licensor retains the right tomanufacture are generally deemed non-exclusive and thus non-reportable under the HSR Act, even if the licensee obtains exclusive rights to use and sell under the patent. These transactions historically have been viewed as distribution agreements, rather than asset acquisitions.

The FTC, however, has determined that the right to manufacture in pharmaceutical licensing arrangements is far less important than the right to commercialize (use and sell) the product. Therefore, the FTC’s proposed amendment treats these types of exclusive arrangements in the pharmaceutical industry — where the licensee obtains the exclusive right to use and sell but the licensor retains the right to manufacture — as the transfer of “all commercially significant rights” and thus potentially reportable under the HSR Act. This change would represent a significant departure from the FTC’s current practice.

Retained “Co-Rights”

In certain licensing arrangements, the licensor often retains “co-rights” when granting an otherwise exclusive license. For example, in the pharmaceutical industry, co-rights provide for the shared responsibility between the licensor and the licensee to see the licensed product through the Food and Drug Administration (FDA) approval process, and the subsequent marketing and promotion of the product (often referred to as “co-development” and “co-marketing” rights). Under current FTC practice, the retention of these co-rights by the licensor does not render the license non-exclusive, therefore they remain potentially reportable licensing arrangements under the HSR Act. The proposed amendments would simply codify this approach without making any change to current practice.

The proposed amendments would modify the HSR Rules contained in 16 C.F.R. §801.1 and §801.2. Click here for the text of the Federal Register Notice, and the full language of the proposed amendments. Comments regarding the proposed amendment must be submitted to the FTC by October 25, 2012.

7th Drug & Medical Device Litigation Forum, 7-8 Mar 2012, Philadelphia

The National Law Review is pleased to inform you of the 7th Drug & Medical Device Litigation Forum: Implementing Appropriate Litigation Readiness and Costs Management Policies That Ensure An Effective Defense at Trial

Drug & Medical Device Litigation Forum 2012

Event Date: 7-8 Mar 2012

Location: Philadelphia, PA, United States

Key conference topics

Mitigate and maintain costs associated with litigation

Gain judical insight on drug and medical litigation and its recent developments

Build better relationships with outside counsel in order to reduce the miscommunciation factor

Understand the limitations of marketing and advertising as it relates to emerging social media issues

Learn the latest on medical device product liability

Conference focus

Pharmaceutical and medical device manufacturers have faced a growing array of legal challenges this year. With the increase of mass tort litigation, as it relates to product liability, pharmaceutical and medical device manufacturers must be prepared to defend the increasingly sophisticated, well-funded and multi-jurisdictional product liability campaigns against their companies.

The 7^th Drug and Medical Device Litigation Conference will be a two-day, industry focused event specific to those within Drug & Medical Device Litigation, Product Liability and Regulatory Affairs in the Medical Device, Biotech and Pharmaceutical industries.

By attending this event, industry leaders will share best practices, strategies and tools on incorporating litigation readiness, utilizing cost efficient litigation strategies and accurately managing policies to ensure an effective defense at trial.

Attending This Event Will Enable You to:
1. Review the current landscape of drug and medical device litigation
2. Learn strategies in settlements and mass tort issues
3. Manage litigation expenses in order to effectively manage costs
4. Review recent case rulings, including the Mensing and Levine cases
5. Take a view from the bench: explore drug and medical device litigation
from a judicial point of view
6. Tackle product liability issues and challenges
7. Uncover the risks for drug and medical device companies when leveraging social media for marketing and advertising campaigns

With a one-track focus, the 7^th Drug and Medical Device Litigation Conference is a highly intensive, content-driven event that includes case studies, presentations and panel discussions over two full days.

This is not a trade show; our Drug and Medical Device Litigation conference series is targeted at a focused group of senior level leaders to maintain an intimate atmosphere for the delegates and speakers. Since we are not a vendor driven conference, the higher level focus allows delegates to network with their industry peers.

Testimonials:

“Great selection & breadth of speakers. Uniformly high quality of presentations. Intimate nature of meeting provided excellent opportunities for networking” – Abbott

“Great venue to learn and exchange best practices. More importantly how to leverage lesions learned from others.” – Baxter

“One of the best meetings I’ve attended. Excellent organization, topics and speakers. Overall extremely well done.” – Sanofi Aventis

marcusevans

7th Drug & Medical Device Litigation Forum, 7-8 Mar 2012, Philadelphia

Event Date: 7-8 Mar 2012

Location: Philadelphia, PA, United States

Key conference topics

Mitigate and maintain costs associated with litigation

Gain judical insight on drug and medical litigation and its recent developments

Build better relationships with outside counsel in order to reduce the miscommunciation factor

Understand the limitations of marketing and advertising as it relates to emerging social media issues

Learn the latest on medical device product liability

Conference focus

Testimonials:

“Great selection & breadth of speakers. Uniformly high quality of presentations. Intimate nature of meeting provided excellent opportunities for networking” – Abbott

“Great venue to learn and exchange best practices. More importantly how to leverage lesions learned from others.” – Baxter

“One of the best meetings I’ve attended. Excellent organization, topics and speakers. Overall extremely well done.” – Sanofi Aventis

marcusevans

7th Drug & Medical Device Litigation Forum, 7-8 Mar 2012, Philadelphia

Event Date: 7-8 Mar 2012

Location: Philadelphia, PA, United StatesKey conference topics

Mitigate and maintain costs associated with litigation

Gain judical insight on drug and medical litigation and its recent developments

Build better relationships with outside counsel in order to reduce the miscommunciation factor

Understand the limitations of marketing and advertising as it relates to emerging social media issues

Learn the latest on medical device product liability

Conference focus

Testimonials:

“Great selection & breadth of speakers. Uniformly high quality of presentations. Intimate nature of meeting provided excellent opportunities for networking” – Abbott

“Great venue to learn and exchange best practices. More importantly how to leverage lesions learned from others.” – Baxter

“One of the best meetings I’ve attended. Excellent organization, topics and speakers. Overall extremely well done.” – Sanofi Aventis

marcusevans

7th Drug & Medical Device Litigation Forum, 7-8 Mar 2012, Philadelphia

Event Date: 7-8 Mar 2012

Location: Philadelphia, PA, United States

Key conference topics

Mitigate and maintain costs associated with litigation

Gain judical insight on drug and medical litigation and its recent developments

Build better relationships with outside counsel in order to reduce the miscommunciation factor

Understand the limitations of marketing and advertising as it relates to emerging social media issues

Learn the latest on medical device product liability

Conference focus

Testimonials:

“Great selection & breadth of speakers. Uniformly high quality of presentations. Intimate nature of meeting provided excellent opportunities for networking” – Abbott

“Great venue to learn and exchange best practices. More importantly how to leverage lesions learned from others.” – Baxter

“One of the best meetings I’ve attended. Excellent organization, topics and speakers. Overall extremely well done.” – Sanofi Aventis

marcusevans

Tag: pharmaceutical

The Evolution of AI in Healthcare: Current Trends and Legal Considerations

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New York To Require Licensure of Pharmacy Benefit Managers