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Lara D. Compton

(she/her/hers)

Member

LDCompton@mintz.com

+.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 at two nonprofit health systems, she also advises health care providers on the incorporation of telehealth and other technology infrastructures, which has seen 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 helped lead the 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 is regularly invited to speak on challenges facing the health care industry, including HIPAA and other regulatory issues.

She maintains an active pro bono practice and has been recognized as a Pro Bono Champion by the American Health Lawyers Association.

A member of the LA Tri Club, Lara trains as a triathlete, runs several triathlons a year, and competes in the 70.3-mile Half Ironman.

Education

  • University of the Pacific (JD, with distinction)
  • University of the Pacific (BA, cum laude)

Experience

Telehealth, Digital Health, and Health Information Technology

  • Structured health technology business models to comply with health care laws and regulations.
  • Represented several telehealth and management company clients in responding to California Medical Board information requests and investigations.
  • Managed regulatory due diligence in connection with the proposed sale of a telehealth provider.
  • Successfully negotiated a software development agreement with a large health care system for a software start-up client.
  • Performed regulatory due diligence for a large health care distribution company’s purchase of a health care technology company.
  • Provided ongoing health care regulatory advice to an EHR company.

Hospitals, Health Systems, and Other Health Care Providers

  • Represented California hospitals in evaluating, negotiating, and drafting physician agreements, including professional services agreements, administrative services agreements, call coverage, and hospital-based agreements.
  • Successfully defended a hospital in a million-dollar dispute with the State of California over an incentive it had earned for being an early adopter of electronic health records (EHR). After a routine audit, the State alleged that our client had counted patients wrongly and should only have received $3.27 million of the $4.21 million it had been paid. The discrepancy turned on complex definitions about what constituted a patient day. Specifically, the State alleged that psychiatric bed days were not eligible to be counted in the total bed days for EHR purposes. We argued that the billing and cost reporting of the psychiatric bed days for our client were countable under the State’s program. The administrative law judge agreed with our position and cut the refund request down to approximately $192,000.
  • Developed business associate toolkit to assist a hospital client in managing business associate relationships.
  • Structured joint patient assistance program to address health information privacy and security requirements.
  • Developed a toolkit to assist a hospital client in managing patients who are refusing discharge or are otherwise difficult to place in an appropriate level of care.
  • Restructured management services agreements to comply with California corporate practice of medicine prohibitions.
  • Investigated health care compliance implementation deficiencies for a hospital system and provided recommendations for improving the compliance program.
  • Served as lead regulatory counsel to a large health system in its Chapter 11 bankruptcy case, the largest hospital bankruptcy in US history. The matter has involved corporate and regulatory support for the system’s day-to-day operations as well as extensive regulatory work on the sale of the system’s six hospitals, including counsel regarding California attorney general conditions and the approval process.
  • Managed due diligence and pre- and post-acquisition notices for venture capital purchase of multiple ambulatory surgery centers and pain clinics.

Life Sciences and Medical Devices

  • Negotiated settlement of disciplinary action with the California Board of Pharmacy for a medical device wholesaler.
  • Evaluated medical device and biotechnology company marketing campaigns for compliance with the federal Anti-Kickback Statute and other fraud and abuse laws.
  • Evaluated proposed marketing materials for stem cell products.
  • Developed a 50-state, post-acquisition regulatory filing plan for a large diagnostics company.

Recognition & Awards

  • Los Angeles Business Journal: Leaders in Law - Firm Attorney Nominees (2021)
  • 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)
  • American Health Lawyers Association: Pro Bono Champion (2014)

Involvement

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

Recent Insights

News & Press

Events

Viewpoints

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In this episode of the Health Law Diagnosed podcast, members of the Mintz Health Law team discuss their health law–focused 2022 New Year’s resolutions and how they’re helping clients and colleagues navigate the continued challenges and opportunities of the current era.
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In the weeks leading up to FDA’s October 14, 2021 Transparency of AI/ML Enabled Medical Devices Workshop (Workshop) we took a brief look at the history of FDA’s regulation of medical device software and the agency’s more recent efforts in regulating digital health. In this post, we will provide an overview of the topics discussed at the Workshop and our impressions of the agency’s likely next steps.
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California’s Senate Bill 41: The Genetic Information Privacy Act

October 19, 2021 | Blog | By Stephnie John, Lara Compton

Our previous blog post on pending California privacy legislation included a prediction that has since materialized: Governor Newsom signed the Genetic Information Privacy Act (“GIPA”) on October 6, 2021, and the law will go into effect on January 1, 2022. GIPA establishes a number of mechanisms to close the existing gap in the protection of genetic information under the current framework of federal and state privacy laws. As discussed in our earlier post, GIPA contains a robust penalty structure, but it includes a number of carve-outs and does not apply to entities already subject to regulation under other health information privacy laws. Notably, GIPA does not reduce or eliminate obligations under other laws, including California’s more broadly applicable consumer privacy laws, such as the CCPA and breach notification statute, as recently amended by AB 825. Given Governor Newsom’s former concern about GIPA’s interference with mandatory COVID-19 testing reporting, the law also does not apply to tests that are conducted exclusively to diagnose whether an individual has a specific disease.
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In our last post, we took a brief look back through history at FDA’s approach to regulating medical device software and found that there is little distinction from the agency’s approach to hardware devices. Recently, however, FDA has announced several digital health initiatives aimed at improving the agency’s resources and policies governing software and data systems (including its own internal data systems) and changing the way the agency handles pre-market reviews of and compliance activities for software as a medical device (SaMD) and SaMD manufacturers. In this post, we will review FDA’s digital health improvement highlights from the past few years and take a quick look at the agenda for the transparency of AI/ML-enabled medical devices workshop scheduled for October 14, 2021.
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October 10th was the last day for Governor Newsom to sign or veto laws that were passed by the legislature this year. 2021 was a busy year for California legislators, who put forth hundreds of health-related bills in the wake of the COVID-19 pandemic. Unsurprisingly, not all of the bills became law (although some of them may be revisited next year). This blog post provides a summary of a few of the new health care laws that were signed into law by Governor Newsom, covering a wide range of health care providers.   
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In anticipation of FDA’s virtual public workshop on transparency of artificial intelligence/machine learning (AI/ML)-enabled medical devices scheduled for October 14, 2021, we will be posting a series detailing the history behind FDA’s regulation of software and then reporting our impressions of FDA’s presentations and statements from various attending stakeholders following meeting. In this part, we briefly summarize FDA’s traditional approach to regulating software and how software development quickly revealed the limitations of the original regulatory framework established in the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act).
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California Health Privacy Information Legislation Update

September 22, 2021 | Blog | By Lara Compton, Stephnie John

When it comes to the privacy of health information, California belongs to the select group of states that have implemented broad consumer privacy protections above and beyond those provided by the federal Health Insurance Portability and Accountability Act (HIPAA) and the Federal Trade Commission Act (FTCA). This year, the state’s ongoing legislative efforts to protect the health information of its residents included: Assembly Bill 1436 (AB 1436) which if enacted would have revised California’s existing Confidentiality of Medical Information Act (CMIA), and Senate Bill 41 (SB 41), which if enacted will create the new Genetic Information Privacy Act (GIPA). As further discussed below, only SB 41 is moving forward, and if signed by Governor Newsom GIPA will go into effect on January 1, 2022.
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On September 15, 2021, in response to the “proliferation of apps and connected devices that capture sensitive health data” the Federal Trade Commission (FTC) issued a Policy Statement ( the Statement) offering guidance on the scope of the FTC’s Health Breach Notification Rule (Breach Rule). According to the Statement, the Breach Rule applies outside of the traditional health care context (e.g. health care involving diagnosis and treatment by a licensed health care provider) and the FTC intends to bring enforcement actions for noncompliance involving up to $43,792 in civil penalties per violation, per day.
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California Health Care Legislative Update

June 15, 2021 | Blog | By Lara Compton

Not surprisingly, in the wake of the COVID-19 pandemic, California legislators proposed hundreds of health-related bills in 2021. For those who are unfamiliar with the intricacies of the Golden State’s legislative process, June 5, 2021 was the deadline for the California Legislature to pass bills introduced in their house of origin. Accordingly, during the week of June 7th, the Senate and Assembly resumed policy committee hearings, reviewing measures from the opposite house.

Along with proposed legislation addressing health care funding, health care access, mental health and substance abuse treatment, disaster preparedness, and other issues brought to the forefront by the pandemic, there are multiple bills that seem to be aimed at various concerns raised by corporate involvement in the provision of health care. Below is an update on a few of the bills that fall into the latter category, including SB 642, which we discussed in more detail in a prior post.
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On May 3, 2021, the California Senate Health Committee approved SB-642 “Health care: facilities: medical privileges.” The bill is currently pending in the California Senate. AB-705, which is substantially similar to SB-642, is also pending in the California Assembly. If passed, the law will curtail hospital governing bodies’ ability to make decisions about the medical services provided at the facility without medical staff approval, impose new limitations on arrangements between management services organizations and professional corporations, and add additional factors to the Attorney General’s review and approval of nonprofit health care facility transactions.
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News & Press

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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.

Events

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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