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Digital Health 

PRACTICE AREA CONTACT

ASAlec Sauchik
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Supporting Digital Health Innovators

The rapidly developing and evolving digital health and healthcare information technology market represents tremendous opportunities but also poses significant risks.  Our mission is to provide the support that digital health innovators need to break the barriers and mitigate uncertainties to advance and prosper.

MDRXLaw attorneys bring a thorough understanding of health law to the vibrant and dynamic field of healthcare information technology and digital health.  Our multi-disciplinary approach to emerging and traditional healthcare legal and regulatory challenges, informed by years of transactional and litigation experience, makes us a valuable partner to any company operating at the point of convergence of technology, health care, medical devices and pharmaceuticals.

We share your vision of the future of healthcare where digital health, artificial intelligence, and instant information exchange among healthcare providers will play as important a role as top-notch medical knowledge and skills and stellar patient care.  We are at the forefront of digital health issues and counsel clients in the following areas:

Information Privacy and Security

From HIPAA compliance to FDA regulations of healthcare IT and everything in between, we provide expert advice on healthcare privacy and security laws, regulations, and practical considerations for established and emerging players in the digital health field.

Intellectual Property

Our multidisciplinary approach permits us to render effective and relevant counsel to digital health companies on matters related to various types of intellectual property.

Digital Health Transactions

When it comes to business agreements in the digital era, traditional contract considerations need to be supplemented with the understanding of the digital business landscape.  We have the knowledge of, and insight into, contracting in the new age of digital health.

Data Analytics and Artificial Intelligence

From privacy implications to data ownership, legal and regulatory implications for companies operating with vast arrays of healthcare-related data can be profound.  Our legal experience is a perfect match for the wide range of digital tools at the disposal of today's and tomorrow's innovators.

Telemedicine

Telemedicine presents unique legal and regulatory challenges because of the multitude of different, and frequently conflicting, laws and regulations applicable to providers in different parts of the country.  We are here to reduce the risks for those who wish to break into the healthcare delivery model of tomorrow.  We provide innovative, dynamic transactional guidance on how to advance along the path to the future of health care - telemedicine.

Patient Engagement and Consumer Wellness Tools

Rationalization, ease of use, seamless customer experience and privacy are the hallmarks of direct-to-consumer services that are establishing the new norm in healthcare delivery.  We creatively analyze new ideas from the legal and regulatory standpoints and help entrepreneurs to innovate in today's rapidly changing legal environment. 

 

Our Services

We deliver the following services to our digital health clients:

Developing Regulatory Strategies

Counseling technology and digital health startups and established companies on choosing the appropriate regulatory strategy and assisting clients in implementing the strategy to achieve desired business goals.

Privacy and Security Planning, Implementation, and Response

Counseling clients on security and privacy laws and guiding clients through compliance with their security and risk analysis obligations under  federal and state laws, and with data-breach response and mitigation.

Full Spectrum of Services for Telemedicine Providers

Advising telemedicine providers on licensure, credentialing, and privileging, e-prescribing, fee-splitting and corporate practice of medicine matters.

Medicare and Medicaid Reimbursement Considerations

Providing guidance to clients on issues related to Medicare and Medicaid reimbursement considerations in the context of digital health delivery applications.

Fraud, Waste and Abuse Compliance

Counseling clients on compliance with the Stark Law, the Anti-Kickback Statute, and other federal and state fraud and abuse laws.

Contract Drafting and Review

Drafting and reviewing contracts for healthcare information technology and digital health products and services.

Start-Up and Corporate Governance Representation

Assisting digital health startups and established companies on the formation, financing, corporate governance matters.

Venture Capital and Private Equity Support

Guiding digital health investors through all stages of venture capital and private equity transactions.

Due Diligence and Investigative Reviews

Conducting health care regulatory, business, and investigatory due diligence in corporate transactions.

M&A and Joint Ventures

Advising and providing transactional legal and regulatory support in connection with joint ventures, mergers and acquisitions, divestitures, and exit stragegies.
 

What We Offer

  • A thorough understanding of health IT, digital health, and the legal and regulatory environment applicable to new and emerging technologies and applications
  • Supporting digital health startups and established entities throughout the entire business cycle
  • Providing comprehensive, relevant, and business-savvy legal and regulatory counsel
  • Multidisciplinary approach to business transactions to minimize regulatory and litigation risks