Michael B. Martinelli, Jd, Ms, Ms Email & Phone Number

Philadelphia, PA, US

Provide legal and strategic consulting for tech-startups in crypto/digital currency. Serve as a c-suite executive and equity holder in our portfolio companies. We focus on utilizing blockchain technology for tokenizing various types of real world assets to enable investors to trade these security tokens on exchanges.

Founder & Principal ConsultantProfessional consulting services specializing in federal healthcare regulatory strategy for digital health firms/startups.

Philadelphia, Pennsylvania, US

Philadelphia, Pennsylvania, US

• Projects centered around testing new business models and advancing the commercialization of innovative biomedical and healthcare-related technologies by translating new inventions into practical applications. Specific.
• Evaluated new ideas and inventions from TJU faculty, scientists, physicians, and employees.
• Performed patentability assessments on select technologies in order to secure necessary protections for TJU-owned IP.
• Conducted market research to assess the market size and the potential share accessible to our new technologies, assessed the competitive landscape and evaluated the potential costs/barriers associated with.
• Reviewed contract language and provisions for MTAs, CDAs, and NDAs, and proposed revisions intended to better protect TJU’s interests.
• Contracts involved material transfers for scientific research, licensing TJU technology to outside partners, collaborating with industry for applied research projects, and creating new startups involving a TJU employee.

San Francisco, CA, US

Government business development.-Secure government contracts (primarily federal) for various innovative healthcare pilot programs for which the Standard Care Protocol can be implemented.Maintain role as regulatory lead for the SC Protocol as it continues to evolve.

San Francisco, CA, US

Member of executive team tasked with overseeing policy matters and regulatory strategy.Author of the Standard Care Protocol Whitepaper. Manage government relations and policy involving digital health and digital health startups. In charge of regulatory strategy for the development and implementation of Standard Care Protocol.-Involves strategically.

Philadelphia, PA, US

• Responsible for maintaining research data quality and integrity, implementing study protocols, managing IRB submissions, and analyzing study data for medical publications.
• Centrally involved in the key stages of clinical trials, from protocol development (investigator-initiated) and site initiation visits (sponsored studies) through study completion and close-out.
• Coordinated several clinical trials that involved conducting patient screening, enrollment, follow-ups (to collect protocol-mandated data), and monitoring patient progress throughout the course of the studies..
• Participated in several site monitoring visits and worked closely with CRAs (both sponsor and CRO).
• Gained months of experience performing these tasking fully remote, and extremely effective working independently in the remote setting.

Philadelphia, Pennsylvania, US

• TA for PSCI 150, International Politics (undergraduate)

Philadelphia, PA, US

• Office of the General Counsel
• Conducted legal research and drafted memos to assist counsel with legal issues from practice areas impacting private medical practice including employment law, M&A’s, nonprofit tax law, anti-trust law, and contract.
• Most duties involved the regulatory affairs division, which included healthcare fraud and abuse (Anti-kickback Statute, Stark Law, FCA), and healthcare compliance issues (HIPAA Privacy/Security Rules).

Philadelphia, PA, US

• Note Topic:
• Physician Payments Sunshine ActCommittees:
• Article Selection Committee
• Membership Committee

Philadelphia, PA, US

• Leonard Davis Institute of Health Economics, The Wharton School
• Conducted research on the implementation of the health insurance marketplaces.
• Examined the division of labor between health insurance marketplaces and state agencies that assume various health insurance regulatory functions, such as plan management, QHP certification, network adequacy, essential.
• Researched consumer assistance tools in certain state-based insurance marketplaces and federally-facilitated marketplaces.
• Analyzed the impact of consumer assistance tools on consumer enrollment in health insurance plans on the marketplaces.
• Created and employed a survey-design methodology for collecting and recording research data.

Washington, District Of Columbia, US

• Office for Civil Rights (OCR)
• Conducted research, prepared and drafted office memos for investigation, enforcement, and litigation strategies involving HIPAA Privacy and Security Rule violations by covered entities and business associates.
• Conducted HIPAA compliance reviews of covered entities and enforced the application of policies to ensure consistency in interpretation of the Privacy and Security Rules.
• Assisted senior staff with special projects associated with outreach activities.Civil Rights:
• Researched and analyzed issues affecting vulnerable populations to support the Department’s policy development.
• Tasks included: conducting legal research on issues involving provisions of civil rights statutes, drafting proposed opinions on individual investigations with established precedents; reviewing and analyzing state and.

Philadelphia, Pennsylvania, US

• Pro-bono legal assistance for low-income cancer patients with various legal issues involving: landlord/tenant disputes, credit debt, mortgage foreclosures, custody disputes, planning documents, and problems receiving.
• Conduct client intakes/preliminary interviews to determine any possible legal issues and record all relevant data.
• Research legal issues and assist my supervising attorney devise the best course of action.

Juris Doctor (Jd), Health Law

Master Of Science - Ms, Public Policy

Master Of Science - Ms, Biomedical Sciences

Certificate In Post-Baccalaureate Pre-Professional Health Studies

Bachelor Of Arts (Ba), Political Science

High School Diploma