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Principal Bio
The founder and principal of Regulatory
Compliance Associates is Dr. McGuinness, is a
seasoned professional in regulatory compliance, with significant experience in both
public and private sector compliance for Privacy, Security/Safeguards,
Application (and Systems), and Business Process compliance. He
has extensive direct experience with GLBA, HIPAA, SOX (Sarbanes-Oxley), DoD
DITSCAP, FDA Good Clinical
Practice, FDA Electronic Records & Electronic Signatures (21CFR11), COPPA, FERPA, and is fluent in other many other
regulatory environments. Recently, he has been heavily involved in
developing and refining compliance requirements for the non-traditional
segments of the GLBA and HIPAA compliance communities, as well as SOX
compliance. In the case of
GLBA, these include: Mail Order & Telemarketers, Auto Dealers, Real Estate & Property Management,
Local Government, Parent Teacher Associations, and more. In the
case of HIPAA, these include: Local Government, School Districts,
Health Intervention Services, Medicaid Providers, Medical Equipment &
Systems Manufacturers, and Business Associates - both local and off-shore.
He also extensive expertise in Dept. of Defense DITSCAP security regulatory
requirements and certification, for both site and commercial products
certifications. Of particular focus are regulatory harmonization
compliance projects involving multiple overlapping regulatory schemas, such
as: SOX + GLBA, HIPAA + GLBA, FERPA + HIPAA, FDA + HIPAA, etc.
He has also been a founding member of regulatory
standards bodies, such as the HIPAA Conformance Certification Organization,
and the newly formed Compliance Professionals Association™. He has
also been a key participant in the development of regulatory standards in
privacy and security, such as the new business associate certification
programs. He also serves as a board member for one of the HIPAA
standards bodies.
He has spent significant time educating the
business and government communities about GLBA, HIPAA, SOX, DITSCAP, and other regulatory
environments. He has collaborated with regulatory educational
organizations, as well as with major service providers to expand awareness
of compliance requirements and methodologies. During 2003, Dr.
McGuinness also presented a weekly one-hour national radio program on HIPAA.
As a specialist in regulatory
compliance, he has been involved at many stages of his career with
State, Federal and International agencies and their regulations, and has
successfully applied their requirements to numerous organizations, products, and
processes. In 1998 he was called upon to apply this knowledge to the
re-invention of the pharmaceutical clinical trials business model.
This involved a comprehensive mapping of all processes and work flows, and
their redesign around web-based automation. This involved the
implementation of a fully FDA 21cfr11, GCP, and HIPAA compliant clinical trials
enterprise application. The result was effectively applied to the development of fully FDA and HIPAA compliant
applications and processes affecting large institutional healthcare
providers as well as small clinics the world over. In addition became heavily involved in healthcare regulations
in the US with the various agencies, such as the FDA & DHH, through the
definition, design or development of applications for: immunization
tracking; clinical patient record management; EMT training and
certification; and practice management. He has directly interfaced
with numerous healthcare providers, pharmaceutical and device manufacturers worldwide, as well as with
international regulatory bodies such as ICH. His regulatory expertise includes
both Homeland Security, Department of Defense, Federal Trade Commission, Health
and Human Services, Food and Drug Administration, International Committee
for Harmonization, ANSI, and ISO standards and regulations, such
as: Gramm Leach Bliley, 5USC552a,
GCP,
21cfr11, HCFA (CMS), HIPAA/ASCA,
FERPA, COPPA, ADA/508c, and numerous other privacy and security statutes, as
well as State statutes. In
the security environment, he is certified and fluent in several schemas,
including GLBA Security (FTC Safeguards), HIPAA Security Rule & Privacy Safeguards, NIST 800, and DoD
DITSCAP.
He is also a professional business technologist, computer scientist, senior solutions
architect, and business analyst. For
over 25 years, he has been re-engineering business processes towards
inventing, developing, and deploying technology to improve our lives in
compliance with broad ranges of requirements, both regulatory and technical. Originally a electronics engineer, then a
software developer; he has developed a large number of professional software
and hardware products. He was also one of a small number of engineers that
developed the first generation personal computers while a Senior Corporate Research
Engineer at Atari at the
beginning of the 80's. Over his career, he has conceived, developed,
managed, or marketed over 400 commercial software products, and dozens of
hardware products, all of which were successfully distributed. The common
thread throughout has always been defining, improving or re-inventing core business processes and
work-flows to provide greater ease, productivity, and compliance. One of his early
products,
FormTool™, remains an all time best-seller,
and is still published after 18 years in distribution!
Dr. McGuinness is also an
entrepreneur, and has created or has collaborated in the creation of
several businesses ranging from eHealth portals, to development enterprises,
to mass-market retail. Many have lead to very successful companies
that have launched products filling numerous market segments, including
federally and internationally regulated eHealth applications in
pharmaceutical clinical trials and practice management, as well as
products for for local and state government. Most recently, his
activities have focused on working with government creating compliant
processes, programs, and products.
Dr. McGuinness presently
provides subject matter expertise and consulting services specializing in
Regulatory Security and Privacy, as well as in related regulatory practices.
He also provides Certification services under DITSCAP, NIST800-37, HIPAA,
and other schemas. In addition, he provides consulting services
associated with the design, implementation, and deployment of web-based
healthcare applications conforming with HIPAA (and other regulations and
rules). He was the founding Board Member and National Co-Chairman for Privacy of the HIPAA Conformance Certification Organization (
HCCO )
, the founder of the Compliance Professionals Association, a participant in the development of HIPAA
implementation requirements by WEDI SNIP. He is also a member of SHARP. Dr. McGuinness
has been the featured speaker at numerous organization's meetings, including
the National Association of Counties, Florida League of Cities conferences, the Florida Academy of Family
Practices, and many more. He has also played a significant role with
the National Association of Counties (NACO) on regulatory issues.
Academically,
he has pursued and obtained several degrees, as well as continuing education, in
several fields that coincided with his core interests, including:
electronics engineering; computer science; process engineering, regulatory
compliance; technical writing, quality assurance; and more; as well as in unrelated fields:
archaeology and anthropology. He has obtained additional
certificates
in or for: FDA Clinical Trial Management, Medical Records Auditing, Good
Clinical Practice, HIPAA Chief Privacy Officer, HIPAA Security, GLBA Privacy
and Security.
For additional information, please send an email
to contact @
regulatorypro . us
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