Mintz - Health Care Viewpoints

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Firm Profile: Mintz
701 Pennsylvania Avenue, N.W.
Washington, DC 20004-2608, United States
Phone: 202-434-7324
Fax: 202-434-7400
Areas Of Practice
  • Administrative Law
  • Commercial Law & Contracts
  • Health
  • Litigation
  • Mergers & Acquisitions
  • Securities Law
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Other U.S. Locations
  • California
  • D.C.
  • Massachusetts
  • New York
Other Countries
  • United Kingdom
Number of Attorneys
400+ Attorneys

ML Strategies Alert - FY2018 Massachusetts Budget Update: House Ways and Means Budget

On Monday, April 10th, the House Ways and Means Committee proposed a $40.3 billion budget for FY2018 that calls for increasing spending by 3.8 percent, or about $1.47 billion, above FY2017 levels. The spending increase is less…more

Economic Development, Educational Institutions, Employee Benefits, Energy Sector, Environmental Policies

See all updates »

Health Care Enforcement Kept the DOJ Fraud Section Busy in 2020

On February 24, 2021, DOJ’s Criminal Division Fraud Section published its annual year-end summary. The Fraud Section focuses on prosecuting white-collar crime. The report summarizes enforcement activity in the past year and…more

Big Data, Bribery, Coronavirus/COVID-19, Department of Justice (DOJ), Enforcement Actions

See all updates »

Massachusetts HPC Health Care Cost Trends Hearing: Key Takeaways

The Massachusetts Health Policy Commission (“HPC”) held its annual Health Care Cost Trends Hearing on October 16-17, 2018. The hearing covered a wide range of topics affecting the health care industry here in the Commonwealth…more

Electronic Medical Records, Health Care Providers, Health Insurance, Healthcare, Healthcare Costs

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Trump Administration Withdraws Proposed Rebate Rule

In an unexpected turn of events, the Trump administration has apparently reversed course and has withdrawn the proposed rule that would have amended the discount safe harbor under the Anti-Kickback Statute to eliminate…more

Anti-Kickback Statute, Drug Pricing, Executive Orders, Medicaid, Medicare

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Charting the Future of Premium Subsidies under the Affordable Care Act: Halbig v. Burwell and King v. Burwell

On July 22, 2014, two federal appellate courts issued conflicting decisions, within hours of each other, regarding the IRS final rule published on May 23, 2012 (the “IRS Rule”), intended to implement the exchange-related tax…more

Affordable Care Act, Halbig v Burwell, Healthcare, IRS, King v Burwell

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Protecting Health Information Post Roe – Part 2: Steps for Health Care Providers

State laws that restrict or criminalize abortions will require significant amounts of health information to enforce, putting new pressure on health care providers caught in the middle of competing obligations to their patients…more

Disclosure Requirements, Electronic Protected Health Information (ePHI), Health Care Providers, HIPAA, HIPAA Breach

See all updates »

Health Care Enforcement Year-in-Review and 2020 Outlook: Criminal Case Developments

As discussed in our article recently published by Law360, criminal health care enforcement in 2019 was in many ways a continuation of 2018, with opioid-related enforcement continuing to be the clear top priority for the…more

Bribery, Controlled Substances Act, Criminal Investigations, Criminal Prosecution, Department of Health and Human Services (HHS)

See all updates »

Health Care Enforcement Year In Review & 2022 Outlook

STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION - FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement…more

Clinical Trials, Coronavirus/COVID-19, Cybersecurity, Department of Justice (DOJ), Enforcement Actions

See all updates »

OIG Approves Manufacturer’s Offer of Free Genetic Testing

The Office of Inspector General for the Department of Health and Human Services (OIG) recently published an Advisory Opinion in which it concluded that the provision of free genetic testing and counseling services by a…more

Advisory Opinions, Anti-Kickback Statute, Civil Monetary Penalty, Clinical Laboratory Testing, Genetic Testing

See all updates »

Congress and the White House Continue Efforts to Respond to Coronavirus

The response to the coronavirus situation is fluid and fast-moving – particularly by Congress’ standards. In response to the coronavirus pandemic, the following legislation has been considered in Congress: Phase I: …more

Appropriation Act, Coronavirus/COVID-19, Families First Coronavirus Response Act (FFCRA), Financial Stimulus

See all updates »

White House Issues Telehealth Guidance on Substance Use Disorder Services

On June 22, 2022, the White House Office of National Drug Control Policy (ONDCP) issued guidance advocating for Congress and federal agencies to make permanent certain telehealth access measures for people struggling with…more

Centers for Medicare & Medicaid Services (CMS), Coronavirus/COVID-19, DEA, Department of Health and Human Services (HHS), Medicaid

See all updates »

ML Strategies Alert - FY2018 Massachusetts Budget Update: House Ways and Means Budget

On Monday, April 10th, the House Ways and Means Committee proposed a $40.3 billion budget for FY2018 that calls for increasing spending by 3.8 percent, or about $1.47 billion, above FY2017 levels. The spending increase is less…more

Economic Development, Educational Institutions, Employee Benefits, Energy Sector, Environmental Policies

See all updates »

Ushering in a New Era: FDA Approves First Interchangeable Biosimilar

Has the Food and Drug Administration (FDA) finally ushered in a new era for the U.S. biosimilar marketplace? Many in the industry are hopeful after the Agency approved its first interchangeable biosimilar, Mylan’s Semglee…more

Biosimilars, Biosimilars Action Plan (BAP), FDA, FTC, Pharmaceutical Industry

See all updates »

A Review of the Affordable Care Act at 10 Years, Part 4: Alternative Payment and Delivery Models

Today's post is the last in our series on the 10-year anniversary of the Affordable Care Act (ACA). While the Congress that passed the ACA recognized that health care delivery reform was necessary, the law included few…more

Affordable Care Act, Antitrust Provisions, Centers for Medicare & Medicaid Services (CMS), CMMI, Healthcare Reform

See all updates »

Congress and the White House Continue Efforts to Respond to Coronavirus

The response to the coronavirus situation is fluid and fast-moving – particularly by Congress’ standards. In response to the coronavirus pandemic, the following legislation has been considered in Congress: Phase I: …more

Appropriation Act, Coronavirus/COVID-19, Families First Coronavirus Response Act (FFCRA), Financial Stimulus

See all updates »

Health Care Enforcement Year In Review & 2022 Outlook

STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION - FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement…more

Clinical Trials, Coronavirus/COVID-19, Cybersecurity, Department of Justice (DOJ), Enforcement Actions

See all updates »

New York Establishes First Pharmacy Benefits Bureau in the Nation as Registration and Annual Reporting Deadlines for Pharmacy Benefit Managers Approach

On May 11, 2022, New York Governor Kathy Hochul announced the creation of the Department of Financial Services’ Pharmacy Benefits Bureau. Governor Hochul noted that the Pharmacy Benefits Bureau is the first of its kind in the…more

Annual Reports, Department of Financial Services, New York, Pharmacy Benefit Manager (PBM), Reporting Requirements

See all updates »

Rough Seas for COVID-19 Serology Tests Lead to Course Correction by FDA

Responding to increased public and congressional criticism of its arguably too-flexible approach to regulatory oversight of serological tests used to detect COVID-19 antibodies, on May 4, 2020, the Food and Drug Administration…more

Coronavirus/COVID-19, Emergency Use Authorization (EUA), FDA, Laboratories, Life Sciences

See all updates »

FCC Seeks Big Role in Telemedicine with New Fund

$100 million in federal funds may soon become available to help health care providers cover the costs of broadband and connected care services. Earlier this month, the Federal Communications Commission (FCC) voted on a proposal,…more

Comment Period, FCC, Federal Pilot Programs, Health Care Providers, Healthcare Reform

See all updates »

Health Care Enforcement Year In Review & 2022 Outlook

STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION - FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement…more

Clinical Trials, Coronavirus/COVID-19, Cybersecurity, Department of Justice (DOJ), Enforcement Actions

See all updates »

Seventh Circuit Adds to Circuit Split Over Standard for DOJ Dismissals in FCA Cases

The Seventh Circuit Court of Appeals recently decided a case that created a new standard to assess requests by the Department of Justice (DOJ) to dismiss declined qui tam (whistleblower) suits under the False Claims Act (FCA)…more

Collateral Order Doctrine, Department of Justice (DOJ), Dismissals, Equal Protection, False Claims Act (FCA)

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With Proposal to Cap Drug Price Increases, Massachusetts Once Again Takes Center Stage in the Drug Pricing Debate

On March 17, the same day we wrote about proposed legislation in Connecticut to cap drug price increases, Governor Charlie Baker of Massachusetts included a similar proposal in his proposed budget. Similar to the Connecticut…more

Affordable Care Act, Drug Pricing, Governor Baker, Medicaid, Medicare

See all updates »

Two Recent False Claims Act Settlements Highlight the Benefits of Self-Disclosure, Remediation, and Cooperation

Disclosing known or suspected fraud to regulators can have its benefits. As reported in a previous post, the Department of Justice (DOJ) issued policy guidance in 2019 on providing credit in False Claims Act (FCA) settlements…more

Anti-Kickback Statute, Cooperation, Department of Justice (DOJ), False Claims Act (FCA), Medicare Advantage

See all updates »

Will a Nonprescription Birth Control Pill Be FDA’s First Approval under its Long-Awaited “ANCU” Proposed Rule?

Unintended downstream consequences are likely to abound in the wake of the June 24, 2022 Dobbs decision that overruled Roe v. Wade, as Mintz attorneys have addressed in other contexts here and here Those looking ahead have…more

Birth Control, Dobbs v. Jackson Women’s Health Organization, FD&C Act, FDA, GAO

See all updates »

ML Strategies Health Care Preview - September 2019

This week, Congressional appropriators are hoping to finalize a continuing resolution (CR) that would extend funding for the government through the middle of November. The House Rules Committee will meet on Tuesday to consider…more

Appropriations Bill, Continuing Resolution, Federal Budget, Health Care Providers, Healthcare

See all updates »

Recent DOJ Comments Shed Light on Expected Civil Enforcement of COVID-19 Cases

Comments made by Department of Justice (DOJ) attorneys during a recent webinar provided insight into the government’s civil enforcement priorities related to the coronavirus pandemic. In particular, government attorneys expect…more

CARES Act, Coronavirus/COVID-19, Department of Health and Human Services (HHS), Department of Justice (DOJ), Enforcement Actions

See all updates »

FDA Releases Final eMDR Rule and Deadline for Compliance

The Food and Drug Administration (FDA) announced and is promulgating today the Final Rule on Electronic Medical Device Reporting (eMDR). Originally proposed in 2009, the rule is now final and a deadline for compliance has been…more

Compliance, FDA, Medical Devices

See all updates »

FDA Releases Ambitious Action Plan for Further Reducing Children’s Exposure to Toxic Elements from Foods

The U.S. Food and Drug Administration (FDA), industry, policymakers, and consumers share a common goal of ensuring that the foods and beverages Americans eat and drink are safe, and the law has long prohibited the adulteration…more

Baby Products, Children's Products, FD&C Act, FDA, Food Manufacturers

See all updates »

Potential Pitfalls of Telehealth Prescribing

As we’ve previously covered, while Congress has acted to extend certain COVID-era telehealth flexibilities (mostly related to Medicare coverage) beyond the Public Health Emergency (PHE), the future of prescribing controlled…more

Controlled Substances, Coronavirus/COVID-19, DEA, Medicare, Public Health Emergency

See all updates »

Senate Democrats Pass Long-Awaited Drug Pricing Reforms in Budget Reconciliation Bill

On August 7, 2022, after extensive deliberation, Senate Democrats passed their long-awaited reconciliation bill, the Inflation Reduction Act of 2022 (the Reconciliation Bill). In addition to climate and tax provisions, the…more

Anti-Kickback Statute, Biosimilars, Budget Reconciliation, Drug Pricing, Medicare

See all updates »

New York Office of Medicaid Inspector General Proposes Regulations on Medicaid Provider Compliance Programs

The New York State Office of Medicaid Inspector General (OMIG) published proposed regulations in the July 13, 2022 issue of the New York State Register. The proposed regulations would repeal the current Part 521 - Provider…more

Certifications, Compliance, Corrective Action Plans (CAPs), Home Health Care, MCOs

See all updates »

Senate Democrats Pass Long-Awaited Drug Pricing Reforms in Budget Reconciliation Bill

On August 7, 2022, after extensive deliberation, Senate Democrats passed their long-awaited reconciliation bill, the Inflation Reduction Act of 2022 (the Reconciliation Bill). In addition to climate and tax provisions, the…more

Anti-Kickback Statute, Biosimilars, Budget Reconciliation, Drug Pricing, Medicare

See all updates »

Commissioner Chopra Releases Statement on Private Equity Physician Practice Roll-Ups with FTC/DOJ HSR Annual Report

On Wednesday, an FTC Commissioner used the occasion of a routine report to Congress to send a warning shot to private equity firms, especially those rolling up health care providers. Commissioner Rohit Chopra, an advisor to…more

Acquisitions, Antitrust Investigations, Competition, Department of Justice (DOJ), FTC

See all updates »

DOJ Announces Another Wide-Ranging COVID-19 Fraud Enforcement Action

For the last few years, we have been closely monitoring and reporting on COVID-19 related fraud enforcement efforts by federal agencies. We detailed those findings in our Health Care Enforcement 2020 Year in Review & 2021…more

Centers for Medicare & Medicaid Services (CMS), Coronavirus/COVID-19, Department of Defense (DOD), Department of Justice (DOJ), Department of Labor (DOL)

See all updates »

Strategies to Unlock AI’s Potential in Healthcare Part 6: Commercialization of AI Tools in Healthcare – the Challenge of Securing Adequate Data Rights

As noted in previous posts in this series, AI tools hold great promise for applications in healthcare. To date, AI tools in healthcare primarily leverage machine learning technology – i.e., the machine’s ability to keep…more

Content Aggregators, Contract Terms, Cybersecurity, Data Collection, Data Privacy

See all updates »

New York Office of Medicaid Inspector General Proposes Regulations on Medicaid Provider Compliance Programs

The New York State Office of Medicaid Inspector General (OMIG) published proposed regulations in the July 13, 2022 issue of the New York State Register. The proposed regulations would repeal the current Part 521 - Provider…more

Certifications, Compliance, Corrective Action Plans (CAPs), Home Health Care, MCOs

See all updates »

FCC to Award Additional $249+ Million in Funding for COVID-19 Telehealth Program

On March 29, 2021, the Federal Communications Commission (“FCC” or “Commission”) adopted an Order establishing rules and procedures for Round 2 of the COVID-19 Telehealth Program (the “Program”) to continue supporting telehealth…more

CARES Act, Consolidated Appropriations Act (CAA), Coronavirus/COVID-19, FCC, Health Care Providers

See all updates »

OIG Expresses Concern about Laboratory Specimen Collection Payments to Hospitals in AO 22-09

Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued Advisory Opinion No. 22-09 (AO 22-09), which addresses a proposed arrangement pursuant to which the operator of a…more

Anti-Kickback Statute, Department of Health and Human Services (HHS), Department of Justice (DOJ), False Claims Act (FCA), Fraud

See all updates »

Protecting Health Information Post Roe – Part 2: Steps for Health Care Providers

State laws that restrict or criminalize abortions will require significant amounts of health information to enforce, putting new pressure on health care providers caught in the middle of competing obligations to their patients…more

Disclosure Requirements, Electronic Protected Health Information (ePHI), Health Care Providers, HIPAA, HIPAA Breach

See all updates »

OIG Releases Semiannual Report to Congress

The Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) recently released its Semiannual Report to Congress (“Report”), summarizing OIG’s activities for the six-month period ending on March 31,…more

Department of Health and Human Services (HHS), Department of Homeland Security (DHS), Department of Justice (DOJ), False Claims Act (FCA), Healthcare

See all updates »

FDA’s New Biosimilar Action Plan Represents the Next Step for Improving Drug Competition

On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action Plan” as another prong within FDA’s broader Drug Competition Action Plan (DCAP), FDA finally unveiled its plan for stimulating…more

Anti-Competitive, Biosimilars, Competition, Drug Pricing, FDA

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PAMA Laboratory Reporting In Flux: ACLA Wins HHS Lawsuit and Congress Introduces PAMA Amendment Legislation

Important developments related to required price reporting to Medicare for clinical laboratories under the Protecting Access to Medicare Act of 2014 (PAMA) have recently occurred. As a result, the clinical laboratory industry…more

Administrative Procedure Act, Centers for Medicare & Medicaid Services (CMS), CLFS, Clinical Laboratories, Department of Health and Human Services (HHS)

See all updates »

Health Care Enforcement Year In Review & 2022 Outlook

STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION - FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement…more

Clinical Trials, Coronavirus/COVID-19, Cybersecurity, Department of Justice (DOJ), Enforcement Actions

See all updates »

Health Care Enforcement Year In Review & 2022 Outlook

STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION - FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement…more

Clinical Trials, Coronavirus/COVID-19, Cybersecurity, Department of Justice (DOJ), Enforcement Actions

See all updates »

Commissioner Chopra Releases Statement on Private Equity Physician Practice Roll-Ups with FTC/DOJ HSR Annual Report

On Wednesday, an FTC Commissioner used the occasion of a routine report to Congress to send a warning shot to private equity firms, especially those rolling up health care providers. Commissioner Rohit Chopra, an advisor to…more

Acquisitions, Antitrust Investigations, Competition, Department of Justice (DOJ), FTC

See all updates »

Two Recent False Claims Act Settlements Highlight the Benefits of Self-Disclosure, Remediation, and Cooperation

Disclosing known or suspected fraud to regulators can have its benefits. As reported in a previous post, the Department of Justice (DOJ) issued policy guidance in 2019 on providing credit in False Claims Act (FCA) settlements…more

Anti-Kickback Statute, Cooperation, Department of Justice (DOJ), False Claims Act (FCA), Medicare Advantage

See all updates »

The Legal and Regulatory Landscape for Wellness Plans: The Affordable Care Act and Beyond

The Patient Protection and Affordable Care Act (the ‘‘Act’’) generally encourages employers to adopt wellness plans and programs in conjunction with their group health plans. Wellness plan vendors tout these arrangements with…more

See all updates »

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act (FCA) Cases: May 2014

Trends & Analysis: ..We have identified 58 health care–related qui tam cases that have been unsealed since our last Qui Tam Update. Of those, 33 cases were initiated after the start of 2012, with the remaining 25 cases…more

Clinical Laboratories, Diagnostic Imaging Services, Financial Conduct Authority (FCA), Healthcare, Hospitals

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Massachusetts Public Health Council Approves Amendments to Clinic Licensure Regulations

On April 28, the Massachusetts Public Health Council (“PHC”) approved final proposed amendments to the clinic licensure regulations. The initial revisions presented by the Department of Public Health (the “Department”) in 2016…more

Amended Regulation, Health Care Providers, Hospitals, Mental Health, Reporting Requirements

See all updates »

PAMA Laboratory Reporting In Flux: ACLA Wins HHS Lawsuit and Congress Introduces PAMA Amendment Legislation

Important developments related to required price reporting to Medicare for clinical laboratories under the Protecting Access to Medicare Act of 2014 (PAMA) have recently occurred. As a result, the clinical laboratory industry…more

Administrative Procedure Act, Centers for Medicare & Medicaid Services (CMS), CLFS, Clinical Laboratories, Department of Health and Human Services (HHS)

See all updates »

Potential Pitfalls of Telehealth Prescribing

As we’ve previously covered, while Congress has acted to extend certain COVID-era telehealth flexibilities (mostly related to Medicare coverage) beyond the Public Health Emergency (PHE), the future of prescribing controlled…more

Controlled Substances, Coronavirus/COVID-19, DEA, Medicare, Public Health Emergency

See all updates »

FCC to Award Additional $249+ Million in Funding for COVID-19 Telehealth Program

On March 29, 2021, the Federal Communications Commission (“FCC” or “Commission”) adopted an Order establishing rules and procedures for Round 2 of the COVID-19 Telehealth Program (the “Program”) to continue supporting telehealth…more

CARES Act, Consolidated Appropriations Act (CAA), Coronavirus/COVID-19, FCC, Health Care Providers

See all updates »

Health Care Enforcement Year-in-Review and 2020 Outlook: Civil Fraud Enforcement Developments and Trends

As discussed in our article recently published by Law360, 2019 brought yet another year of robust health care enforcement activity, and the False Claims Act (FCA) remains the government’s most powerful civil health care…more

Department of Justice (DOJ), Dismissals, Enforcement Actions, False Claims Act (FCA), Health Care Providers

See all updates »

Ebola Exclusions from Commercial Insurance Policies

Last week we wrote about a new business interruption insurance policy that is being rolled out to healthcare providers which will provide specific coverage for various ebola-related losses. This week we note that some business…more

Business Interruption, Commercial Insurance Policies, Ebola

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ICYMI: Biosimilars and FDA Regulatory Webinar

Our Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation. Linda and Joanne discussed statutory provisions related to FDA’s authority to approve…more

Biosimilars, BPCIA, FDA, FDA Approval, Pharmaceutical Industry

See all updates »

PBM Regulatory Roundup (Summer 2022): States Continue PBM Oversight Activities

2022 continues to see a surge in state-led PBM enforcement efforts. This roundup provides a brief summary of Louisiana’s complaint against United Healthcare and OptumRx related to its Medicaid program and recent state…more

Breach of Contract, Louisiana, Medicaid, Pharmacy Benefit Manager (PBM), Regulatory Oversight

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PBMs Continue to Draw Federal Scrutiny: PBM Transparency Act of 2022

As we noted in our last PBM Regulatory Roundup, there has been a wave of state regulation focused on PBM practices in the wake of Rutledge and Webhi. However, PBMs are also facing federal reform efforts. The Pharmacy Benefit…more

Drug Pricing, FTC, MCOs, OIG, Pharmacy Benefit Manager (PBM)

See all updates »

Heritage Pharmaceuticals Admits to Generic Drug Price Fixing Scheme

In the latest development in the Department of Justice (DOJ) Antitrust Division’s ongoing investigation into the generic pharmaceutical industry, Heritage Pharmaceuticals, Inc. has entered into a deferred prosecution agreement…more

Anticompetitive Behavior, Criminal Conspiracy, Criminal Convictions, Criminal Penalties, Deferred Prosecution Agreements

See all updates »

Commissioner Chopra Releases Statement on Private Equity Physician Practice Roll-Ups with FTC/DOJ HSR Annual Report

On Wednesday, an FTC Commissioner used the occasion of a routine report to Congress to send a warning shot to private equity firms, especially those rolling up health care providers. Commissioner Rohit Chopra, an advisor to…more

Acquisitions, Antitrust Investigations, Competition, Department of Justice (DOJ), FTC

See all updates »

Pharma Distributors Trade Association Sued for Conspiracy to Exclude Competition for its Track and Trace Software

On October 23, 2017, a company that developed software to track and trace pharmaceuticals filed a complaint against a pharmaceutical distributors trade association that currently dominates the market for such software, alleging…more

Anti-Competitive, Antitrust Violations, Coercion, Contract Solicitation, Life Sciences

See all updates »

Strategies to Unlock AI’s Potential in Health Care, Part 1: Common Pitfalls to Avoid When Getting a Patent

As in any area of technology, it is important to consider patent protection early in the development of an AI-related invention. However, AI and other digital health inventions raise a number of particular issues that, if not…more

Artificial Intelligence, CLS Bank v Alice Corp, Design Patent, Digital Health, Emerging Technology Companies

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Seeking FCC Flexibility on the Sale of Wireless Medical Devices During COVID-19

We’ve written previously about the role of the Federal Communications Commission (FCC) in regulating wireless medical devices, chiefly in determining the operating frequency and certain technical rules that ensure co-existence…more

Certification Requirements, Emergency Waivers, FCC, General Electric, Medical Devices

See all updates »

Biden Administration Throws Down Its First Gauntlet on 340B

On May 17, 2021, the Biden Administration took its first major action impacting the 340B Drug Discount Program. In a forceful statement, the Administration made plain its views on a major controversy that has pitted drug…more

Biden Administration, Drug Pricing, HRSA, Pharmaceutical Industry, Prescription Drugs

See all updates »

Have You Updated Your HIPAA Security Risk Assessment Lately?

Last week, the HHS Office for Civil Rights (OCR) and the Office of the National Coordinator for Health Information Technology (ONC) hosted a webinar on the HIPAA Security Risk Assessment Tool (SRA Tool or the Tool). The webinar…more

Cybersecurity, Department of Health and Human Services (HHS), Electronic Protected Health Information (ePHI), Health Industry Cybersecurity Practices (HICP), HIPAA

See all updates »

HRSA Demands Repayment from Providers that Failed to Comply with Provider Relief Fund Reporting Requirements

Under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the Health Resources and Services Administration (HRSA) of the Department of Health and Human Services (HHS) is authorized to distribute funds from its…more

CARES Act, Coronavirus/COVID-19, Department of Health and Human Services (HHS), HRSA, Medicare

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It’s Not Really ”Repeal and Replace”; It’s Transition

For the last six years, Republicans have talked about repeal and replacement of the Affordable Care Act. The election outcome now puts Republicans in a position of authority to take action on the Affordable Care Act. As we…more

Affordable Care Act, Healthcare Reform, Presidential Elections, Trump Administration

See all updates »

HHS Finalizes Highly Anticipated Final Rules Amending AKS and Stark Law Regulations, Part III: Value-Based Arrangements

As promised, our team has been studying the two final rules published by the Department of Health & Human Services (HHS) (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services…more

Anti-Kickback Statute, Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), DMEPOS, Final Rules

See all updates »

OIG Issues Favorable Opinion on Federally Qualified Health Center’s Smartphone Loan Program

On April 27, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services issued Advisory Opinion No. 22-08 (AO 22-08), which addresses an existing arrangement of a federally qualified health…more

Advisory Opinions, Anti-Kickback Statute, Coronavirus/COVID-19, FCC, FQHC

See all updates »

FDA’s Review of Pulse Oximeter Performance Continues a Trend in Addressing Biases in Digital Health Technologies

The U.S. Food and Drug Administration (FDA) will schedule a public meeting of the Medical Devices Advisory Committee later this year to discuss study results, real-world data, and other evidence concerning the accuracy and…more

Artificial Intelligence, Biometric Information, Clinical Trials, Digital Health, Diversity

See all updates »

Flagging Judgment: Medical Necessity as a Focus of Fraud and Abuse Enforcement Actions

Physician judgment and medical necessity increasingly are a focus of fraud and abuse enforcement actions, with statistical analysis of procedure volumes used to flag potential cases. Last week, the Atlantic published this recent…more

Enforcement Actions, False Claims Act (FCA), Fraud and Abuse, Health Care Providers, Healthcare Fraud

See all updates »

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  • Content and other public information (such as an author profile) is shared on our Website and Services, including via email digests and social media feeds, and is accessible to the general public.
  • If you choose to use our Website and Services to communicate directly with a company or individual, such communication may be shared accordingly.
  • Readership information is provided to publishing law firms and companies and authors of content to give them insight into their readership and to help them to improve their content.
  • Our Website may offer you the opportunity to share information through our Website, such as through Facebook's "Like" or Twitter's "Tweet" button. We offer this functionality to help generate interest in our Website and content and to permit you to recommend content to your contacts. You should be aware that sharing through such functionality may result in information being collected by the applicable social media network and possibly being made publicly available (for example, through a search engine). Any such information collection would be subject to such third party social media network's privacy policy.
  • Your information may also be shared to parties who support our business, such as professional advisors as well as web-hosting providers, analytics providers and other information technology providers.
  • Any court, governmental authority, law enforcement agency or other third party where we believe disclosure is necessary to comply with a legal or regulatory obligation, or otherwise to protect our rights, the rights of any third party or individuals' personal safety, or to detect, prevent, or otherwise address fraud, security or safety issues.
  • To our affiliated entities and in connection with the sale, assignment or other transfer of our company or our business.

How We Protect Your Information

JD Supra takes reasonable and appropriate precautions to insure that user information is protected from loss, misuse and unauthorized access, disclosure, alteration and destruction. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. You should keep in mind that no Internet transmission is ever 100% secure or error-free. Where you use log-in credentials (usernames, passwords) on our Website, please remember that it is your responsibility to safeguard them. If you believe that your log-in credentials have been compromised, please contact us at privacy@jdsupra.com.

Children's Information

Our Website and Services are not directed at children under the age of 16 and we do not knowingly collect personal information from children under the age of 16 through our Website and/or Services. If you have reason to believe that a child under the age of 16 has provided personal information to us, please contact us, and we will endeavor to delete that information from our databases.

Links to Other Websites

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

  • Our Legal Basis for Processing: Generally, we rely on our legitimate interests in order to process your personal information. For example, we rely on this legal ground if we use your personal information to manage your Registration Data and administer our relationship with you; to deliver our Website and Services; understand and improve our Website and Services; report reader analytics to our authors; to personalize your experience on our Website and Services; and where necessary to protect or defend our or another's rights or property, or to detect, prevent, or otherwise address fraud, security, safety or privacy issues. Please see Article 6(1)(f) of the E.U. General Data Protection Regulation ("GDPR") In addition, there may be other situations where other grounds for processing may exist, such as where processing is a result of legal requirements (GDPR Article 6(1)(c)) or for reasons of public interest (GDPR Article 6(1)(e)). Please see the "Your Rights" section of this Privacy Policy immediately below for more information about how you may request that we limit or refrain from processing your personal information.
  • Your Rights
    • Right of Access/Portability: You can ask to review details about the information we hold about you and how that information has been used and disclosed. Note that we may request to verify your identification before fulfilling your request. You can also request that your personal information is provided to you in a commonly used electronic format so that you can share it with other organizations.
    • Right to Correct Information: You may ask that we make corrections to any information we hold, if you believe such correction to be necessary.
    • Right to Restrict Our Processing or Erasure of Information: You also have the right in certain circumstances to ask us to restrict processing of your personal information or to erase your personal information. Where you have consented to our use of your personal information, you can withdraw your consent at any time.

You can make a request to exercise any of these rights by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
150 Harbor Drive, #2760
Sausalito, CA 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

  • Timeframe for retaining your personal information: We will retain your personal information in a form that identifies you only for as long as it serves the purpose(s) for which it was initially collected as stated in this Privacy Policy, or subsequently authorized. We may continue processing your personal information for longer periods, but only for the time and to the extent such processing reasonably serves the purposes of archiving in the public interest, journalism, literature and art, scientific or historical research and statistical analysis, and subject to the protection of this Privacy Policy. For example, if you are an author, your personal information may continue to be published in connection with your article indefinitely. When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize it, or, if this is not possible (for example, because your personal information has been stored in backup archives), then we will securely store your personal information and isolate it from any further processing until deletion is possible.
  • Onward Transfer to Third Parties: As noted in the "How We Share Your Data" Section above, JD Supra may share your information with third parties. When JD Supra discloses your personal information to third parties, we have ensured that such third parties have either certified under the EU-U.S. or Swiss Privacy Shield Framework and will process all personal data received from EU member states/Switzerland in reliance on the applicable Privacy Shield Framework or that they have been subjected to strict contractual provisions in their contract with us to guarantee an adequate level of data protection for your data.

California Privacy Rights

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
150 Harbor Drive, #2760
Sausalito, CA 94965

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

Access/Correct/Update/Delete Personal Information

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to privacy@jdsupra.com. We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to privacy@jdsupra.com.

Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at: privacy@jdsupra.com.

JD Supra Cookie Guide

As with many websites, JD Supra's website (located at www.jdsupra.com) (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

  1. Improve the user experience on our Website and Services;
  2. Store the authorization token that users receive when they login to the private areas of our Website. This token is specific to a user's login session and requires a valid username and password to obtain. It is required to access the user's profile information, subscriptions, and analytics;
  3. Track anonymous site usage; and
  4. Permit connectivity with social media networks to permit content sharing.

There are different types of cookies and other technologies used our Website, notably:

  • "Session cookies" - These cookies only last as long as your online session, and disappear from your computer or device when you close your browser (like Internet Explorer, Google Chrome or Safari).
  • "Persistent cookies" - These cookies stay on your computer or device after your browser has been closed and last for a time specified in the cookie. We use persistent cookies when we need to know who you are for more than one browsing session. For example, we use them to remember your preferences for the next time you visit.
  • "Web Beacons/Pixels" - Some of our web pages and emails may also contain small electronic images known as web beacons, clear GIFs or single-pixel GIFs. These images are placed on a web page or email and typically work in conjunction with cookies to collect data. We use these images to identify our users and user behavior, such as counting the number of users who have visited a web page or acted upon one of our email digests.

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

  • HubSpot - For more information about HubSpot cookies, please visit legal.hubspot.com/privacy-policy.
  • New Relic - For more information on New Relic cookies, please visit www.newrelic.com/privacy.
  • Google Analytics - For more information on Google Analytics cookies, visit www.google.com/policies. To opt-out of being tracked by Google Analytics across all websites visit http://tools.google.com/dlpage/gaoptout. This will allow you to download and install a Google Analytics cookie-free web browser.

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit http://www.aboutcookies.org which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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