Building general image

Healthcare & Life Sciences

Healthcare & Life Sciences

Healthcare & Life Sciences

Download PDFDownload PDF
Print
Share

Overview

Paving the way for cutting-edge industry transformation

BCLP’s global Healthcare team is a leader in providing legal services to the healthcare industry. We use our experience in the healthcare industry to help you to:

  • achieve strategic goals;
  • provide practical, business-focused guidance on regulatory compliance and operational issues;
  • developing and executing complex transactions; and
  • representing you in commercial litigation.

As healthcare continues to be transformed by technological advances and an ever-changing regulatory environment, we know you trust us to advise you on cutting-edge, transformational matters including telemedicine, health IT, transparency, and alternative payment methodologies.

We represent a large spectrum of global industry participants from medical device companies, hospitals and health systems to private equity and other investors.

Our cross-discipline approach combines capabilities in compliance, privacy and data security, transactions, real estate government investigations, litigation, corporate, finance, tax, intellectual property and regulatory areas. As a result, we have a thorough understanding, not only of the legal and business issues, but also of the policies and principles that underlie and influence the healthcare sector, ensuring that you receive the best possible support and guidance.

 

one of the world’s leading competition practices

Competition Review 

The healthcare industry continues to face unprecedented innovation as regulatory complexity, rate pressure and patient demands keep evolving. These accelerated structural and operational challenges require clients to examine their capabilities and processes and develop a commitment to drive transformative growth while maintaining ongoing compliance.  Working together, we help organizations build tomorrow’s healthcare ecosystem by creating skillful models to mitigate risk and address the myriad challenges that are top of mind for healthcare executives across geographies, including:

  • ACO, CIN, MSO, PHO formation and operation
  • Compliance program structure
  • Corporate practice of medicine, dentistry and veterinary compliance (including fee-splitting rules)
  • Fraud and abuse compliance (including anti-kickback and Stark law reforms)
  • Internal governance
  • HIPAA, 42 C.F.R. Part 2 and state-level privacy compliance
  • Management services arrangements
  • No Surprises Act, Hospital Transparency Act and other transparency law compliance
  • Medicare & Medicaid regulations
  • Physician practice organization and management
  • Scope of practice, licensure and supervision requirements for mid-level providers, nurses, and medical assistants in hospital, urgent care and post-acute care settings.

Technology trends in today’s digital world can be both an organization’s greatest asset as well as vulnerability. It is only by fully understanding the technology that underpins many of the privacy opportunities and challenges that we help healthcare companies address their full suite of privacy needs.

Our team assists clients navigate the intersection of complicated global and US laws that uniquely apply to health care and life sciences organizations, such as the EU and UK GDPR, the CCPA/CPRA and other emerging US state laws, as well as HIPAA, 42 C.F.R. Part 2 and state-level privacy laws.

Having a world-class incident response practice helps you navigate major security incidents and data breaches, such as ransomware. We help you identify and remediate gaps in readiness and train executives on how to respond to breaches effectively.

With healthcare policy top of mind for policymakers, you need a full-service firm that uses turn-key government strategy and regulatory solutions regarding federal healthcare policies for transformative growth. We have experience in:

  • legislative drafting and analysis;
  • development of regulatory strategies;
  • identifying and securing federal funding; and
  • policy forecasting that helps healthcare participants sharpen their focus on innovative business plan development.

Our bipartisan team includes many former senior government officials, including assistant U.S. attorneys and chief counsels of congressional committees.

This collaborative team provides us with a wide variety of established strong working legislative, state and congressional relationships with key healthcare decision-makers on Capitol Hill.

From single-asset deals to large scale portfolios, our global Real Estate Healthcare Team delivers dynamic client service, and practical, business-oriented advice on the full range of healthcare transactions.

Owners, operators, developers, managers, REITs, institutional investors, public sector bodies, and other health industry organizations rely on our strong understanding of the key issues to anticipate and avoid potential hazards.

Read our Real Estate Healthcare experience >

We combine global coverage with local knowledge of markets and regulatory regimes. This means we provide commercially-focused, full-service competition and regulatory counsel to help you identify — and avoid — potential competition issues before they become problems.

However, when concerns do arise, we are well-equipped to offer innovative, efficient, and effective solutions to help you assess your options and develop a strategy to minimize your risks. We are continually recognized for our work, and Global Competition Review has named us “one of the world’s leading competition practices”. 

We offer advice on day-to-day employment matters to high-stakes litigation and transactional support.

Our team spans 21 offices in the U.S., UK, Dubai, France, and Germany, as well as a strong presence and extensive experience advising in Asia.

We have a strong track record of advising healthcare industry participants across these jurisdictions in common employment issues such as:

  • policies
  • training and benefits
  • safeguarding of trade secrets
  • enforcement of non-competes
  • physician employment and affiliations
  • equity incentive arrangements
  • physician employment; and
  • affiliations.

Healthcare enforcement continues to be a top priority world-wide.  We ensure that your interests are protected today and are prepared to withstand regulatory scrutiny tomorrow. From domestic courts to specialist tribunals and  international arbitration, we are known for our experience in handling multijurisdictional matters in all areas, including:

  • Acute-care violations
  • Class actions
  • Commercial litigation and civil disputes
  • Contract disputes
  • Disputes with third-party payors
  • Enforcement actions
  • Insurance coverage disputes
  • Internal and criminal investigations
  • Labor and employment disputes, Non-compete litigation
  • Government investigations
  • False Claims Act Medical malpractice defense and non-medical personal injury defense
  • Physician termination disputes
  • Qui tam (whistleblower)
  • White collar criminal litigation, including alleged Antikickback, Stark law and False Claims Act violations

We work in concert with all types of healthcare organizations to develop tailored strategies to drive business and maximize goals through: 

  • Corporate research and marketing partnerships
  • Due diligence
  • Financings and reorganizations
  • Joint ventures, combinations and strategic alliances, including management arrangement and other innovative alignments
  • M&A, including multistate roll-ups and dispositions
  • Private equity and venture capital
  • Review, negotiation and preparation of agreements
  • Structuring review and guidance related to fraud and abuse and corporate practice of medicine compliance.
Jennifer Csik Hutchens

Jennifer Csik Hutchens

Partner and Global Leader - Healthcare & Life Sciences Team, Charlotte

+1 704 749 8931
Anne P. Sharamitaro
+1 314 259 2570
Jennifer Csik Hutchens

Jennifer Csik Hutchens

Partner and Global Leader - Healthcare & Life Sciences Team, Charlotte

+1 704 749 8931
Jean-Patrice Labautière
+33 (0) 1 44 17 77 36
Anne P. Sharamitaro
+1 314 259 2570

Meet The Team

Jennifer Csik Hutchens

Jennifer Csik Hutchens

Partner and Global Leader - Healthcare & Life Sciences Team, Charlotte

+1 704 749 8931
Jean-Patrice Labautière
+33 (0) 1 44 17 77 36
Anne P. Sharamitaro
+1 314 259 2570

Related Insights

Insights
May 16, 2024

Navigating the FemTech regulatory landscape

Security, scale or functionality – pick two. This computer science principle coined by the late Professor Anderson is particularly relevant to the FemTech industry. Anderson’s Rule states that for a system to provide high functionality and security, its access may need to be limited (small scale); alternatively, offering high functionality on a larger scale, may require an acceptance of risk, e.g. of inadvertent or deliberate disclosure of information. In real life systems - including FemTech - a balance must be struck. It is no surprise, then, that the regulatory landscape for FemTech is complex and fragmented. Different jurisdictions approach the question of health/medical data in diverse ways and apply different laws and standards to the protection of personal data. All these rules are ultimately intended to mitigate the risks to personal data posed by large databases of sensitive personal information while facilitating the benefits. In part two of our series, we examine the UK, EU and US regulatory privacy landscapes and enforcement priorities and how they apply to the FemTech sector. For more, read our previous article "What is femtech and how can it meet the privacy needs of its users?".
Insights
Mar 08, 2024

What is FemTech and how can it meet the privacy needs of its users?

In part one of our series "FemTech: how this growing industry can build trust, protect privacy and redress healthcare inequity… one app at a time", we take an introductory look at the industry, and offer some commercially-minded approaches to address users’ privacy needs.
Insights
Feb 21, 2024

Lessons from the growth of FemTech and women’s health

BCLP’s Healthcare & Life Sciences Practice Group recently partnered with EMIG Digital Health Group to co-host an in-person breakfast seminar and networking event focused on FemTech. Specialists from across the FemTech and wider digital health, pharma and life sciences sectors heard speakers from Flo Health, Apricity and Theramex, amongst others, discuss key themes and lessons learnt from the growth of FemTech. Chaired by Darren Spevick, Managing Director of Russell Strategy Partners, topics discussed included the ecosystem and market and how innovation, effective partnerships, high quality content, and a simple and tangible digital strategy can drive growth in the sector. Attendees also heard from members of BCLP’s dedicated FemTech team about the current themes in, and the direction of travel for, UK and EU privacy and data protection and how robust compliance can help to fuel trust and drive value.

Related Insights

News
Oct 09, 2024
BCLP advises OrbiMed on restructuring and financing agreement with listed company Poxel
Insights
Jul 19, 2024
Navigating the FemTech regulatory landscape: best practice & future developments
News
May 30, 2024
Partner Amy de Lama and Associate Andrea Rastelli share insights on Washington My Health My Data Act FAQs: Data Subject Rights
Insights
May 16, 2024
Navigating the FemTech regulatory landscape
Security, scale or functionality – pick two. This computer science principle coined by the late Professor Anderson is particularly relevant to the FemTech industry. Anderson’s Rule states that for a system to provide high functionality and security, its access may need to be limited (small scale); alternatively, offering high functionality on a larger scale, may require an acceptance of risk, e.g. of inadvertent or deliberate disclosure of information. In real life systems - including FemTech - a balance must be struck. It is no surprise, then, that the regulatory landscape for FemTech is complex and fragmented. Different jurisdictions approach the question of health/medical data in diverse ways and apply different laws and standards to the protection of personal data. All these rules are ultimately intended to mitigate the risks to personal data posed by large databases of sensitive personal information while facilitating the benefits. In part two of our series, we examine the UK, EU and US regulatory privacy landscapes and enforcement priorities and how they apply to the FemTech sector. For more, read our previous article "What is femtech and how can it meet the privacy needs of its users?".
Events
Apr 15, 2024
American Health Law Association’s Health Care Transactions Program
Insights
Mar 08, 2024
What is FemTech and how can it meet the privacy needs of its users?
In part one of our series "FemTech: how this growing industry can build trust, protect privacy and redress healthcare inequity… one app at a time", we take an introductory look at the industry, and offer some commercially-minded approaches to address users’ privacy needs.
Insights
Feb 21, 2024
Lessons from the growth of FemTech and women’s health
BCLP’s Healthcare & Life Sciences Practice Group recently partnered with EMIG Digital Health Group to co-host an in-person breakfast seminar and networking event focused on FemTech. Specialists from across the FemTech and wider digital health, pharma and life sciences sectors heard speakers from Flo Health, Apricity and Theramex, amongst others, discuss key themes and lessons learnt from the growth of FemTech. Chaired by Darren Spevick, Managing Director of Russell Strategy Partners, topics discussed included the ecosystem and market and how innovation, effective partnerships, high quality content, and a simple and tangible digital strategy can drive growth in the sector. Attendees also heard from members of BCLP’s dedicated FemTech team about the current themes in, and the direction of travel for, UK and EU privacy and data protection and how robust compliance can help to fuel trust and drive value.
News
Feb 05, 2024
BCLP advise Aedifica on establishment of UK REIT
Insights
Jan 15, 2024
Life sciences - ESG holy grail for the life sciences sector