Through effective use of healthcare information technology (HIT), healthcare providers can improve the health and well-being of their patients. At the same time, HIT holds the promise to permit providers to serve more patients (e.g., through telemedicine), while improving population health (e.g., through electronic healthcare records and disease registries).
At Melnik Legal, we help clients navigate the HIT regulatory framework in order for them to improve the lives of their patients, to provide betters services, and to protect the data entrusted to them. We negotiate and draft agreements, review and advise on regulations, and consult on related business matters.
At Melnik Legal we work with organizations and providers spanning the gamut of healthcare delivery, ranging from healthcare providers and independent physician associations, to established healthcare vendors such as data centers, to technology start-ups.
For more details, see Representative Matters.
- Review and negotiation of data sales agreements, data sharing agreements, licensing agreements and others
- Regulatory compliance
- Data ownership and other intellectual property issues
- Disease Registry
- Data Sharing and Data Use Agreements
- Patient Authorization Review
- Electronic Health Records (EHR), Electronic Medical Records (EMR), and Personal Healthcare Records (PHR)
- Acquisition and implementation of EHRs/EMR/PHRs, including review of master purchase agreements, statements of work, and addendums
- Certification issues
- Compliance with FTC regulations
- Fraud concerns
- Meaningful Use compliance and incentive program
- Safety concerns
- Health Information Exchanges (HIEs)
- Mobile Health (mHealth)
- Privacy and security counseling (e.g., Office of Civil Rights (OCR), Federal Trade Commission (FTC), State Attorney Actions)
- Bring Your Own Device (BYOD) policy drafting and counseling
- ESI management and best practices
- Mobile app development agreements
- Food, Drug and Cosmetic Act compliance
- Controlled Substances Act compliance
- Fraud and Abuse Anti-Kickback Statute compliance
- Physician dispensing regulations
- E-prescribing and telemedicine
- Regulatory review and compliance counseling
- Transactional Services
- Data sharing and data use agreements
- Clinical and disease registry agreements
- Internet and technology-use policies
- Consulting and services agreements
- Consulting on IT procurement and development issues
- Contract review and negotiations
Other Healthcare Services
- Regulatory compliance (Stark and mini-Stark, Anti-Kickback, False Claims Act, fraud & abuse issues)
- Data and records management polices and procedures and state and federal records management laws
- General business management services
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|Related Presentations |
Managing ESI within Health Information Systems -- Now they've Gone Mobile, Panel Member, ABA Information Governance, Electronic Discovery and Digital Evidence National Institute, Jan. 29, 2014.
- HIPAA, It's not just for Hospitals Anymore - Data Center Obligations Under HIPAA/HITECH, 2014 BICSI Winter Conference & Exhibition, Feb. 6, 2014
Identity Fraud and Data Breaches: Criminal and Civil Enforcement Efforts, 2014 HIMSS Conference, Feb. 24, 2014.
- Executive Officer Leadership Summit of the National Council of State Boards of Nursing on various issues including, general privacy and legal issues with social media as they impacting nursing, and social media implementation and related concerns, Co-Speaker, June 19, 2012.
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