Crowell Health Solutions

• Strategic planning and business counseling (e.g., counseling on new business models and product offerings)
• Advising on federal contracts
• Advising on acquisition strategy
• Operational and organizational process improvements
• Advising on FDA strategy
• Advising on pricing and reimbursement strategy
• Opportunity / risk analysis
• Value proposition / substantiation
• Due diligence
• Support organizational positioning within marketplace
• Market opportunity assessment

• Identifying proactive policy priorities
• Policy monitoring (tailored to client or subscription service)
• Policy and regulatory analysis
• Developing policy options and recommendations
• Federal and state advocacy
• Drafting comment responses to federal policy proposals
• Thought leadership, including roundtables, white papers, articles, research, and collateral material development

• Advising on regulatory compliance
• Advising on reimbursement and coding
• Advising on Medicare reimbursement of new devices
• Internal policy development and implementation, including training staff on compliance
• Health care compliance counseling (ACOs, plans, providers)
• Supporting compliance planning and implementation
• Advising on product and service development to align with regulatory compliance
• Compliance/Privacy Program
  • Effectiveness Reviews
  • Policy Development
  • Infrastructure Design
  • Training
  • Monitoring and Assessment Services
  • Consulting Support During Government Investigations

• Developing and maintaining industry coalitions
• Advising on regulatory and advocacy strategy for existing and future coalitions
• Providing recommendations on private / governmental partnerships
• Managing stakeholder engagements and working on stakeholder mapping and analysis
• Connecting clients with potential partners
• Advising on communications strategies

Our Compliance Services

Compliance is crucial for your Accountable Care Organization’s (ACO) success. We know that the ever-evolving health care regulatory landscape can be challenging. Today’s ACOs must understand the requirements of federal and state Anti-Kickback Statutes, False Claims Act, Stark Law, rapidly developing health care privacy and HIPAA laws, and commercial contract requirements.

Crowell Health Solutions’ experienced team of consultants regularly work alongside ACOs, health care providers, digital health and technology companies, and drug and device manufacturers. We specialize in navigating the complex world of health care compliance, and offer a range of supports to help you do the same. 

We look forward to providing your team with the following services:

• Conducting Environmental/Risk Assessments: We look forward to assessing your organization’s ACO and HIPAA “compliance health, while monitoring regulatory changes specific to your region.
• Developing Compliance Programs/Recommendations: Our risk assessment will determine how we craft our personalized plan and recommendation for your organization’s policies or waivers.
• Providing Compliance Trainings: We’ll develop trainings that will help your team adhere to compliance regulations and provide your team with a toolkit for navigating the everchanging ACO and health information landscapes.
• Delivering Ongoing Compliance Counseling: Compliance adherence isn’t a one-time service, we’re here for on-going continued support to address all your ACO and privacy needs as they arise.

In today's dynamic healthcare landscape, the challenges of navigating regulatory complexities and managing escalating costs are more pronounced than ever. It is imperative for organizations, whether they are in the early stages of development or have a well-established presence, to employ strategic and cost-efficient decision-making practices. This approach is crucial to maintaining agility and competitiveness.

At Crowell Health Solutions, we are committed to empowering both emerging and mature life sciences organizations. Our team of seasoned professionals offers bespoke assistance designed to bolster, transform, and sustain your operations in healthcare, research, and medical devices on a global scale.

Our comprehensive service offerings to life sciences organizations encompass:

• Emerging Company Start Up Advisory Services
• Pipeline and Portfolio Review for Strategic Operational and Organizational Solutions
• Contracting and Budget Support
• Manufacturing and Distribution Logistics and Operations
• Human Subject Protections/Informed Consent Development
• Privacy and Cybersecurity Services
• Data and Artificial Intelligence
• Advice related to Clinical Trial Management Systems Consulting
• Work Force Regulatory Training
• Strategic IP Portfolio Development
• Pharmaceutical and Device Product Development Regulatory Services
• Clinical Trial Strategy for Regulatory Compliance
• Drug Marketing Advisory Services
• Healthcare Business Strategy Consulting
• Strategic Partnership Development

In the current digital healthcare space, artificial intelligence (AI), mobile health (mHealth), personalized medicine, telehealth and telemedicine services, data analysis, and medical devices are driving today’s healthcare delivery system. With those developments come increasing federal and state compliance regulations and privacy concerns.

Whether your organization or business needs assistance creating a compliance program, securing health data for services, or training staff on new digital health policies, our experienced team of former federal healthcare legal veterans can help you stay 100% compliant.

We look forward to providing your team with the following services:

• Regulatory Assessments and Developing Compliance Programs/Recommendations: We conduct assessments and will identify gaps in your organization’s current compliance program and analyze data flows to better understand how your organization protects, collects, maintains, uses, and discloses health information. Based on our risk assessment, we will develop a compliance program and compliance department structure tailored to your company.
• Assessing Health Care Privacy and Data Security: It is important to evaluate whether your organization is complying with HIPAA and other federal and state data protection laws. We will draft privacy statements, HIPAA-required documents, and terms of use while helping your organization respond to security incidents and threats.
• Providing Compliance Trainings: We will develop trainings to help your team adhere to compliance regulations and provide your team with a toolkit for navigating the everchanging digital health landscape.
• Delivering Ongoing Compliance Counseling: Compliance adherence is not a one-time service. We are here for on-going continued support to address all your compliance and privacy/security needs and will continue to update your compliance, interoperability and privacy/security documents and reports as regulations and requirements change.
• Preparation of Compliance-Related Policies and Procedures: We draft and revise existing privacy notices and internal policies and procedures to help your organization align with current regulatory requirements.

The pursuit of healthcare solutions is fundamentally driven by research and innovation. Yet, the highly competitive nature of the research environment presents significant challenges for healthcare organizations. These challenges include cultivating a culture of compliance within research activities and creating effective strategies to identify and support promising innovations, whether for presentations to investment partners or for direct market introduction.

At Crowell Health Solutions, we are acutely aware of these challenges and are dedicated to providing comprehensive support to hospitals, universities, research institutes, contract research organizations (CROs), and related entities. Our focus is on addressing regulatory and operational matters, thereby facilitating the resolution of these critical issues.

Our approach is centered on assisting organizations in refining their research and development processes. By streamlining these processes, we enhance overall operations, fostering an environment that supports compliant, efficient, and cost-effective scientific research. Establishing such a framework is pivotal in nurturing a culture conducive to innovation and compliance alike.

Furthermore, once we establish a robust pipeline, our team helps develop processes and platforms tailored to effectively identify the most promising innovations. This strategic focus ensures a more efficient research strategy, ultimately accelerating the path from concept to market.

Our service offerings in this domain include:

• Grants Management
  • Effort Reporting Advice
  • Uniform Guidance Advice and Support
  • Federal Grant Audit Support
• Responsible/Ethical Conduct of Research
  • Institutional Review Board Support
  • Conflicts of Interest Advice and Support
  • Researcher Misconduct Inquiry and Internal Investigation
• Research Operational Assistance (Clinical, Bench, Grants, etc.)
  • Assessment and Performance Improvement
  • Interim Management
  • Sponsored Project Oversight
  • Mock Audits/Assessments
  • FDA Regulatory Support
  • GMP, GCP Compliance Audits
• Strategies to Develop, License and Market Innovations
  • Developing Business Strategy
  • Identifying Licensing, Joint Venture and Acquisition Opportunities
  • Support for In-house or Spin-off Product Development
  • IP Portfolio Development Strategies
  • Identifying and Acquiring Investment