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Lara D. Compton

(she/her/hers)

Member

[email protected]

+.1.424.259.4019

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Lara is a trusted advisor to clients ranging from traditional health care providers to disrupter digital health platforms as they navigate the practical and regulatory challenges of health care innovation. Her unique depth of knowledge across HIPAA privacy and other regulatory issues governing the use of data, state and federal fraud and abuse laws, business planning and operational issues has led colleagues to describe Lara as the “Swiss Army knife” of health care problem-solving.

Working at the intersection of health care and technology, Lara counsels telemedicine and other digital health clients on business plan strategy and implementation, state-specific telemedicine regulation, corporate practice of medicine, the scope of practice, fee splitting, anti-kickback, reimbursement, and other health care regulatory issues. Leveraging her prior in-house experience, she advises health care providers on the incorporation of telehealth and other technology infrastructures, which saw a vast uptick as a result of the COVID-19 pandemic.

Lara advises health care providers, clinical trials companies, ancillary providers, technology start-ups, HMOs, insurance companies, and large technology companies on HIPAA and other health data privacy and security regulations, including developing and implementing HIPAA compliance programs. She has also led significant HIPAA breach investigations, advising clients on risk management and mitigation efforts.

Prior to joining Mintz, Lara was a partner at a boutique health care law firm, where she co-chaired the transactional/regulatory practice regulatory practice, guiding clients not only on risk avoidance but also on essential challenges of growth, including the transition to value-based care arrangements and the development of new health technology and digital health-related products and services. She also served as an in house attorney at two nonprofit health systems, Sutter Health and Community Medical Centers, where she advised extensively on Anti-Kickback, Stark Law, day-to-day operational risk and cost control management as well as creating, evaluating and implementing internal policies, compliance programs, and marketing and training initiatives.

Lara regularly speaks on challenges facing the health care industry, including HIPAA and other regulatory issues presented by the development and implementation of health care technologies. 

She maintains an active pro bono practice, has been recognized as a Pro Bono Champion by the American Health Lawyers Association, and is a member of the firm’s Pro Bono Committee.

Lara is passionate for health and wellness and serves as the attorney chair for Mintz’s Wellness Committee. She is a member of the LA Tri Club, trains as a triathlete, runs several triathlons a year, and competes in the 70.3-mile Half Ironman.

Experience

Telehealth, Digital Health, and Health Information Technology

  • Structured health technology business models to comply with health care laws and regulations, including strategic guidance on the provision of professional services across the United States and compliance with state corporate practice of medicine prohibitions.
  • Represented several telehealth management service organizations in responding to California Medical Board information requests and investigations.
  • Managed regulatory due diligence on for buyers and sellers in connection with a variety of telehealth and health technology transactions.
  • Negotiated and provided regulatory counsel for wide range of digital health and health information technology agreements.
  • Provided ongoing health care regulatory advice to a wide range of digital health and health information technology companies.

Hospitals, Health Systems, and Other Health Care Providers

  • Assisted health care providers in developing and implementing new technologies. For example, assisted in navigating the regulatory issues posed by the development of a patient screening health app co-developed by a physician and a hospital.
  • Regularly assisted a broad range of health care providers in monitoring and navigating California health care regulatory requirements and enforcement, including but not limited to corporate practice of medicine prohibitions and other provider licensing laws, Physician Ownership and Referral Act and other state fraud and abuse laws, state health information privacy and security laws such as the California Consumer Privacy Act of 2018 as amended by the California Privacy Rights Act, Genetic Information Privacy Act, Confidentiality of Medical Information Act, Patient Access to Health Records Act, Lanterman Petris Short Act, and state breach reporting laws.
  • Represented clients across the health care industry (health plans, publicly traded companies, nonprofit hospitals, private equity backed health care providers) in performing/responding to health care regulatory due diligence on a variety of health care providers and addressing regulatory issues and requirements that arose in the context of the transaction. Regularly assisted a wide range of clients in responding to breach investigations, health information privacy and security audits and requests for information. Represented a client in responding to a wide scale California County information privacy and security audit which involved a forensic system assessment and onsite inspection, twenty employee interviews, multiple sets of questionnaire responses, and the production of hundreds of documents.
  • Developed a wide range of health care operational tools, for example toolkits for managing business associate relationships and managing patients who are refusing discharge or are otherwise difficult to place in an appropriate level of care.
  • Regularly conducted a wide range of regulatory compliance audits and investigations (e.g. HIPAA, fraud, waste, and abuse) for a variety of health care providers and assisted with process improvement and risk mitigation strategies.

Life Sciences and Medical Devices

  • Assisted a variety of clients with licensing requirements related to device distribution, for example negotiated settlement of disciplinary action with the California Board of Pharmacy for a medical device wholesaler and developed a 50-state, post-acquisition regulatory filing plan for a large diagnostics company.
  • Evaluated medical device and biotechnology company marketing campaigns for compliance with the federal Anti-Kickback Statute and other fraud and abuse laws.
  • Evaluated FDA regulatory implications for a variety of cellular and tissue based products and analyzed proposed product marketing materials for FDA and FTC regulatory implications.

Health Plans

  • Regularly advised on health information privacy and security law compliance issues. For example, advised health plans regarding the collection, use, and sharing of data for product development and marketing initiatives.
  • Advised California health plans regarding issues related to medical practice, for example California requirements for prescribing birth control pills using telehealth and California health care provider licensing and supervision requirements relevant to the quality assurance program.
  • Advised health plans regarding health care regulatory considerations related to vertical integration efforts, including transactional regulatory due diligence, fraud and abuse compliance advise, and risk management.
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viewpoints

Mintz Health Law attorneys discuss regulations recently proposed by California’s newly established Office of Health Care Affordability, which call for advance regulatory review of certain health care entity mergers, acquisitions, affiliations, and other arrangements.
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January 1, 2024 is rapidly approaching, which is when California’s new Office of Health Care Affordability (OHCA) is set to begin advance regulatory review of certain health care mergers, acquisitions, affiliations, and other arrangements that result in material changes of assets, control, or governance. The law establishing OHCA left many details regarding the types of transactions that would be subject to review to be established by emergency regulations, which have been proposed and are available here. A public workshop will be held on August 15, 2023 (more information here), allowing for public comment and the written comment period will be open until August 31, 2023. The final emergency rulemaking package is expected to be submitted in October 2023.
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A little over a year after the Dobbs v. Jackson Women’s Health Organization decision, the Food and Drug Administration (FDA) continues to be at the forefront of addressing reproductive health concerns. An example of this activity came just a few days after the FDA approved the first nonprescription daily oral contraceptive for marketing in the U.S. when the agency sent a warning letter to Wise Women’s Choice (WISE) in connection with the marketing and sale of its “birth control cream.” Among other things, this warning letter highlights for consumers the importance of confirming that birth control methods are safe, effective, and FDA-approved for their intended uses.
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Covered entities, business associates, and any entities that collect health information about consumers online should carefully review the latest joint letter from the Office for Civil Rights (OCR) and the   Federal Trade Commission (FTC). On July 20, 2023, the agencies sent a joint letter to approximately 130 hospital systems and telehealth providers warning them about “serious privacy and security risks related to the use of online tracking technologies” such ad Google Analytics and Meta/Facebook Pixel. That letter was subsequently shared publicly and should be reviewed by any entity subject to regulation by either agency.   
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Covered entities, business associates, and any entities that collect health information about consumers online should carefully review the latest joint letter from the Office for Civil Rights (OCR) and the   Federal Trade Commission (FTC). On July 20, 2023, the agencies sent a joint letter to approximately 130 hospital systems and telehealth providers warning them about “serious privacy and security risks related to the use of online tracking technologies” such ad Google Analytics and Meta/Facebook Pixel. That letter was subsequently shared publicly and should be reviewed by any entity subject to regulation by either agency.   
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Washington greatly expanded the protection for consumers’ identifiable health information by enacting the “My Health My Data Act” (MHMDA), in an effort to close the gap between HIPAA protections and the laws protecting the privacy and security of other consumer health care data. While MHMDA resembles the acts in both California and Illinois, it broadly applies to health information outside of traditional health care settings. In this article we answer frequently asked questions about MHMDA’s applicability and requirements.
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Washington greatly expanded the protection for consumers’ identifiable health information by enacting the “My Health My Data Act” (MHMDA), in an effort to close the gap between HIPAA protections and the laws protecting the privacy and security of other consumer health care data. While MHMDA resembles the California Consumer Privacy Act as amended by the California Privacy Rights Act (CCPA) and the Illinois Biometric Information Privacy Act (BIPA), it broadly applies to health information outside of traditional health care settings. Regulated Entities should consider undertaking additional steps that we outline now to prepare for the March 31, 2024, and June 30, 2024 (small businesses) compliance deadlines.
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Governor Gavin Newsom signed multiple pieces of mental health treatment-related legislation into law in 2022 that have or will begin to go into effect this year. These laws address mental health commitment timing and hearing rights, involuntary mental health treatment, the CARE program, and substance use disorder treatment client rights. This is a good time for relevant facilities and groups to audit the effectiveness of updated policies and evaluate and address any operational issues that may have cropped up during implementation.
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In April, 2020, in an effort to facilitate a national pivot to telehealth in light of the COVID-19 Public Health Emergency (PHE), the U.S. Department of Health & Human Services Office for Civil Rights (OCR) announced a policy of Health Insurance Portability and Accountability Act of 1996 (HIPAA) enforcement discretion for regulated health care providers (Covered Entities) implementing communications technologies that weren’t fully compliant with HIPAA or using those technologies in a manner that didn’t comply with HIPAA. Examples of flexibilities included allowing technology providers access to protected health information (PHI) without a HIPAA Business Associate Agreement (BAA). OCR’s enforcement discretion enabled Covered Entities to minimize the need for in-person visits for all kinds of health care services, not just COVID-19 related care. OCR also implemented flexibilities to promote public health during the COVID-19 pandemic; for example, it allowed for Business Associates to share COVID-19 data with government agencies for such purposes without specific authority to do so under BAAs.  
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The Federal Trade Commission (FTC) recently kicked off enforcement of its Health Breach Notification Rule (Breach Rule) by taking aim at GoodRx’s use of tracking technologies (e.g. pixels) and the sharing of consumer health data for advertising purposes. According to Samuel Levine, director of the FTC's Bureau of Consumer Protection, the FTC “is serving notice that it will use all of its legal authority to protect American consumers' sensitive data from misuse and illegal exploitation." Bottom line, HIPAA applicability may no longer be as significant of a factor when it comes to the risk presented by collecting, using, disclosing, and maintaining identifiable health information (IHI).
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News & Press

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Mintz is pleased to announce that 120 firm attorneys have been recognized as leaders by Best Lawyers® in the 2024 edition of The Best Lawyers in America©.
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Member Lara Compton spoke to Bloomberg Law about the increased state regulations on major health-care transactions.
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Los Angeles, CA – Mintz is pleased to announce that Members Lara Compton and Arameh Zargham O’Boyle have been named 2023 Visionaries by the Los Angeles Times’ Business of Law. Ms. Compton and Ms. O’Boyle were recognized for being leaders in their fields and for their contributions to the legal industry over the past two years.
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LOS ANGELES – Mintz Members Lara Compton and Kathryn Edgerton have been named to the Los Angeles Business Journal’s 2023 Women of Influence: Attorneys list. This selective honor recognizes less than 100 women in the Los Angeles region.
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In an article published by HealthITSecurity, Mintz Member Lara Compton shared insights into what health apps should expect moving forward due to the Federal Trade Commission’s recent health breach notification policy statement.
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Events & Speaking

Panelist
Nov
10
2023

Complex Health Information Privacy and Security: HIPAA and Beyond

California Society for Healthcare Attorneys 2023 Fall Seminar

Irvine, CA

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Speaker
Aug
24
2023

Clinically Integrated Networks in a Value-Based Care World and the New Regulatory Landscape: What You Need To Know

Legal and Regulatory Issues for CINs, Organizational Structure, Governance, and More

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May
10
2023

Tracking Technologies and Health Information: A Prescription to Avoid Enforcement Action Headaches

Association of Corporate Counsel 2023 Life Sciences Conference

Online Event

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Speaker
May
4
2023

California Fraud and Abuse

2023 CSHA California Healthcare Law Essentials

Renaissance Esmeralda Resort & Spa

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Speaker
Jan
31
2023

New Technology: Considerations for Evaluation, Development, and Implementation?

Physicians and Hospitals Law Institute 2023

Renaissance Orlando at SeaWorld®

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Speaker
May
25
2022

The Evolving Health Care Privacy Landscape

Women Business Leaders of the U.S. Health Care Industry Foundation (WBL) Event

Online Event

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Speaker
Apr
6
2022

Telehealth Risk Management

Mintz

Online Event

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Speaker
Oct
22
2021

Health Law Review 2021 Virtual Fall Symposium

Indiana University Robert H. McKinney School of Law

Online Event

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Moderator
Oct
20
2021

Cultivating Well-Being and Success

Mintz

Shutters on the Beach, Santa Monica, CA

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Aug
18
2021

Health Care Leadership Panel & Awards

Los Angeles Business Journal

Virtual Event

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Speaker
Jun
30
2021

Provider Compliance: Information Blocking and Patient Access

California Society for Healthcare Attorneys

Webinar

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Recognition & Awards

  • Best Lawyers in America: Health Care Law (2023 - 2024)
  • Los Angeles Business Journal Women's Leadership Awards Nominees (2022-2023)
  • Named a Business of Law Visionary in the Los Angeles Times B2B Publishing's Business of Law: Trends, Updates, Visionaries magazine (2022-2023)
  • Los Angeles Business Journal Leaders of Influence: Thriving in Their 40s (2022)
  • Recognized by the Los Angeles Business Journal as one of the Trusted Advisors of the Year for the Health Care Leadership and Panel Awards - Attorney Nominees (2021); Finalist (2022)
  • Los Angeles Business Journal: Leaders in Law - Firm Attorney Nominees (2021)
  • American Health Lawyers Association: Pro Bono Champion (2014)
  • Los Angeles Business Journal: Women of Influence: Attorneys (2023)
  • Los Angeles Business Journal: Women of Influence: Health Care (2023)
  • Los Angeles Business Journal: Woman to Watch (2023)
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Involvement

  • Member, American Health Lawyers Association
  • Member, California Society for Healthcare Attorneys
  • Vice Chair, LACBA-LACMA Committee on Biomedical Ethics
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